What are the common side effects of risedronate. How can patients manage these side effects. When should a patient seek medical attention for risedronate side effects. What are the potential long-term effects of risedronate use.

Common Side Effects of Risedronate: What to Expect

Risedronate, like all medications, can cause side effects in some individuals. While many people experience no side effects or only minor ones, it’s important to be aware of potential reactions. Common side effects, occurring in more than 1 in 100 people, include:

• Constipation
• Diarrhea
• Indigestion, bloating, stomach pain, or wind
• Nausea
• Headaches
• Mild muscle, bone, or joint pain

Understanding these common side effects can help patients better manage their treatment and know when to seek medical advice.

Managing Gastrointestinal Side Effects of Risedronate

Gastrointestinal issues are among the most frequently reported side effects of risedronate. How can patients alleviate these symptoms?

Dealing with Constipation

To combat constipation, patients are advised to:

• Increase intake of high-fiber foods such as fresh fruits, vegetables, and cereals
• Drink plenty of water
• Engage in regular exercise, such as daily walks or runs

Coping with Diarrhea

If experiencing diarrhea, it’s crucial to:

• Drink lots of fluids to avoid dehydration
• Consult a pharmacist if signs of dehydration occur, such as decreased urination or dark, strong-smelling urine
• Avoid self-medicating without professional advice
• Be aware of potential interactions with contraceptive pills if diarrhea is severe and prolonged

Alleviating Indigestion and Related Issues

For indigestion, bloating, stomach pain, or wind, patients should:

• Follow instructions for taking risedronate carefully, including sitting or standing for at least 30 minutes after taking the medication
• Consider eating smaller, more frequent meals
• Eat and drink slowly
• Maintain regular exercise

If symptoms worsen, immediate medical attention is necessary.

Addressing Nausea and Headaches Associated with Risedronate

Nausea and headaches can be challenging side effects for some patients. How can these symptoms be managed effectively?

Managing Nausea

To help alleviate nausea:

• Stick to simple meals
• Avoid rich or spicy foods
• Consider eating smaller, more frequent meals throughout the day

Coping with Headaches

For headache relief:

• Ensure adequate rest
• Stay hydrated by drinking plenty of fluids
• Limit alcohol consumption
• Use over-the-counter painkillers as recommended by a pharmacist

If headaches persist for more than a week or become severe, consult a doctor.

Recognizing and Responding to Serious Side Effects of Risedronate

While less common, serious side effects can occur with risedronate use. Prompt recognition and response are crucial. When should patients seek immediate medical attention?

Contact a doctor or emergency services immediately if experiencing:

• Severe heartburn or difficulty swallowing
• Dental issues such as loose teeth, mouth sores, or jaw pain
• Pain or discomfort in the thigh, hip, or groin
• Severe joint, muscle, or bone pain
• Ear pain, discharge, or infection
• Black or red stools
• Vision problems or eye pain
• Muscle cramps, spasms, or tingling sensations

These symptoms may indicate serious complications and require prompt medical evaluation.

Understanding the Risk of Allergic Reactions to Risedronate

Although rare, risedronate can cause severe allergic reactions (anaphylaxis). How can patients identify a potential allergic reaction, and what actions should they take?

Signs of a serious allergic reaction include:

• Skin rash (itchy, red, swollen, blistered, or peeling)
• Wheezing
• Tightness in the chest or throat
• Difficulty breathing or talking
• Swelling of the mouth, face, lips, tongue, or throat

If any of these symptoms occur, seek emergency medical attention immediately by calling 999 or going to the nearest A&E department. Prompt treatment is essential in cases of anaphylaxis.

Long-Term Effects and Considerations for Risedronate Use

Extended use of risedronate may lead to rare but significant long-term effects. What should patients be aware of when using this medication for extended periods?

For a small number of individuals taking risedronate for more than two years, there is an increased risk of:

• Rare bone damage in the inner ear
• Certain types of thigh bone fractures

To monitor long-term effects:

• Doctors typically reassess the benefits and risks of treatment after 5 years
• Bone density tests may be conducted to evaluate bone strength
• Based on these assessments, healthcare providers will advise whether to continue or discontinue treatment

It’s important to note that for most patients, the benefits of taking risedronate outweigh the potential risks. However, open communication with healthcare providers about any concerns is crucial for optimal treatment management.

Reporting and Monitoring Risedronate Side Effects

Vigilant reporting of side effects is essential for ongoing medication safety. How can patients contribute to this process?

The Yellow Card safety scheme provides a platform for reporting suspected side effects. Patients and healthcare professionals can use this system to:

• Report any unusual or concerning symptoms potentially related to risedronate use
• Contribute to the ongoing safety monitoring of the medication
• Help identify new or rare side effects that may not be currently known

By actively participating in side effect reporting, patients play a crucial role in improving medication safety for themselves and others.

Balancing Benefits and Risks: Making Informed Decisions About Risedronate Treatment

While side effects are a concern, it’s essential to consider the overall picture of risedronate treatment. How can patients and healthcare providers work together to make informed decisions?

To ensure optimal treatment outcomes:

• Regularly discuss the benefits and potential risks of risedronate with healthcare providers
• Report any new or persistent side effects promptly
• Attend scheduled follow-up appointments and bone density screenings
• Consider lifestyle factors that may impact bone health, such as diet and exercise
• Explore alternative treatments if side effects become problematic or if risedronate efficacy diminishes over time

By maintaining open communication and actively participating in treatment decisions, patients can help ensure that the benefits of risedronate continue to outweigh any potential risks.

Beyond Common Side Effects: Rare and Uncommon Reactions to Risedronate

While the focus is often on common side effects, it’s important to be aware of rare and uncommon reactions that may occur with risedronate use. What are some of these lesser-known effects?

Rare side effects of risedronate may include:

• Esophageal ulcers or erosions
• Osteonecrosis of the jaw (ONJ)
• Atypical femur fractures
• Eye inflammation
• Severe skin reactions

While these reactions are uncommon, awareness is crucial. Patients should:

• Familiarize themselves with the potential for these rare side effects
• Report any unusual symptoms to their healthcare provider promptly
• Understand that early detection and intervention can often mitigate more serious complications

Healthcare providers play a vital role in educating patients about these potential reactions and monitoring for early signs during treatment.

Risedronate and Bone Health: Maximizing Benefits While Minimizing Risks

Risedronate is prescribed to improve bone health, but how can patients maximize its benefits while minimizing potential risks?

To optimize risedronate treatment:

• Follow dosing instructions carefully, including proper posture after taking the medication
• Maintain adequate calcium and vitamin D intake through diet or supplements as recommended by a healthcare provider
• Engage in weight-bearing exercises and strength training to support bone health
• Avoid smoking and limit alcohol consumption, as these can negatively impact bone density
• Attend regular check-ups and bone density scans as scheduled
• Discuss any concerns or changes in health status with healthcare providers promptly

By combining medication adherence with lifestyle modifications, patients can enhance the effectiveness of risedronate while potentially reducing the risk of side effects.

Special Considerations: Risedronate Use in Specific Populations

Certain groups may require special consideration when using risedronate. How does treatment approach differ for these populations?

Elderly Patients

Older adults may be more susceptible to certain side effects and require:

• Closer monitoring for gastrointestinal issues
• Regular assessment of kidney function
• Careful evaluation of fall risk and preventive measures

Patients with Kidney Issues

Those with impaired kidney function may need:

• Dose adjustments based on kidney function tests
• More frequent monitoring of serum calcium and phosphate levels
• Consideration of alternative treatments if kidney function is severely compromised

Pregnant or Breastfeeding Women

Risedronate use in pregnancy and breastfeeding requires careful consideration:

• The medication is generally not recommended during pregnancy due to potential risks to the fetus
• Breastfeeding mothers should discuss the risks and benefits with their healthcare provider before use

Tailoring treatment approaches to specific patient populations ensures safer and more effective use of risedronate.

Future Directions: Research and Developments in Risedronate Treatment

As medical science advances, what can patients expect in terms of future developments in risedronate treatment and side effect management?

Ongoing research in bisphosphonate therapy, including risedronate, focuses on:

• Developing new formulations with potentially fewer side effects
• Investigating optimal treatment durations and drug holiday periods
• Exploring combination therapies to enhance efficacy and reduce risks
• Improving methods for early detection of rare but serious side effects
• Personalized medicine approaches to tailor treatment based on individual patient factors

Patients should stay informed about these developments and discuss emerging options with their healthcare providers to ensure they receive the most up-to-date and appropriate treatment for their specific needs.

Side effects of risedronate – NHS

Like all medicines, risedronate can cause side effects in some people, but many people have no side effects or only minor ones.

Common side effects

These common side effects of risedronate happen in more than 1 in 100 people. There are things you can do to help cope with them:

Constipation

Eat more high-fibre foods such as fresh fruit, vegetables and cereals, and drink plenty of water. Try to exercise more regularly, by going for a daily walk or run for example.

Diarrhoea

Drink lots of fluids such as water or squash to avoid dehydration. Speak to a pharmacist if you have signs of dehydration, such as peeing less than usual or having dark, strong-smelling pee. Do not take any medicines to treat diarrhoea without speaking to a pharmacist or doctor.

If you take contraceptive pills and you have severe diarrhoea for more than 24 hours, your contraception may not protect you from pregnancy. Check the pill packet for advice.

Indigestion, bloating, stomach pain or wind

Make sure you follow the instructions for taking risedronate carefully and sit or stand for at least 30 minutes after taking it. It might help to eat smaller and more frequent meals, eat and drink slowly, and exercise regularly.

If the symptoms get worse, contact your doctor straight away.

Feeling sick (nausea)

Stick to simple meals and do not eat rich or spicy food.

Headaches

Make sure you rest and drink plenty of fluids. Do not drink too much alcohol. Ask your pharmacist to recommend a painkiller.

Talk to your doctor if the headaches last longer than a week or are severe.

Mild muscle, bone or joint pain

Make sure you rest and drink plenty of fluids. Do not drink too much alcohol. Ask your pharmacist to recommend a painkiller.

Talk to your doctor if the pain lasts longer than a week or is severe.

Speak to a doctor or pharmacist if the advice on how to cope does not help and a side effect is still bothering you or does not go away.

Serious side effects

Some people may have serious side effects when taking risedronate.

Tell a doctor or contact 111 straight away if you have:

• heartburn (or heartburn that gets worse), or problems or pain when swallowing – these may be signs of ulcers in your food pipe. If this happens, stop taking risedronate and speak to a doctor
• a loose tooth, mouth sores, or swelling or pain in your mouth or jaw – contact your dentist as well as your doctor, as this could be a sign of damage to your jawbone
• pain, weakness or discomfort in your thigh, hip or groin – this happens rarely but may be an early sign of a broken thigh bone
• severe pain in the joints, muscles or bones
• ear pain, discharge from your ear or an ear infection – these can be signs of damage to the bones in your inner ear
• black or red poo – these can be signs of an ulcer or bleeding from your gut
• blurred vision, light sensitivity, or painful or red eyes – these can be signs of swelling of the eye
• muscle cramps or spasms, a tingling sensation in your fingers or around your mouth – these can be symptoms of low calcium levels in your blood

Go to 111. nhs.uk or call 111.

Serious allergic reaction

In rare cases, risedronate may cause a serious allergic reaction (anaphylaxis).

Immediate action required: Call 999 or go to A&E now if:

• you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
• you’re wheezing
• you get tightness in the chest or throat
• you have trouble breathing or talking
• your mouth, face, lips, tongue or throat start swelling

You could be having a serious allergic reaction and may need immediate treatment in hospital.

Long-term side effects

For a very small number of people, taking risedronate for more than 2 years can increase their chances of getting a rare type of bone damage in their inner ear and certain types of breaks to their thigh bones.

If risedronate is working for you long term, your doctor will look at the benefits and risks of your treatment after 5 years. They may do some tests to check the strength (density) of your bones. Then they’ll advise you if you should keep taking it.

The benefits of taking risedronate generally outweigh the risks. If you’re concerned or have any questions, talk to your doctor or pharmacist.

Other side effects

These are not all the side effects of risedronate. For a full list, see the leaflet inside your medicine packet.

Information:

You can report any suspected side effect using the Yellow Card safety scheme.

Visit Yellow Card for further information.

Page last reviewed: 25 October 2022

Next review due: 25 October 2025

Side Effects, Dosage, Uses, and More

Highlights for risedronate

1. Risedronate is available as brand-name drugs and as generic drugs. Brand names: Actonel, Atelvia.
2. Risedronate comes in two forms: immediate-release tablet and delayed-release tablet. Both forms are taken by mouth.
3. Risedronate is used to prevent or treat osteoporosis. It’s also used to treat Paget’s disease of bone.

• Sores in the esophagus warning: Risedronate may cause ulcers (sores) in the esophagus. These can be severe. Your doctor may monitor you for signs of these problems. These signs can include trouble swallowing, pain when swallowing, chest pain, or frequent heartburn.
• Muscle and bone pain warning: Risedronate can cause severe bone, joint, or muscle pain. If you have these symptoms, stop taking this drug and call your doctor.
• Bone death of the jaw warning: Risedronate can cause poor blood supply to the jaw. This may lead to osteonecrosis (bone death) of the jaw. This is more likely to occur after a major dental procedure. If you need to have dental work done, tell your doctor. You may need to stop taking this drug.
• Broken bones warning: Risedronate can cause unusual fractures in the hip or leg bones. Before a fracture, you may have a dull, aching pain in your hips, groin, or thighs for weeks to months. If you have this kind of pain, talk to your doctor.

Risedronate is a prescription drug. It comes in the form of an immediate-release tablet or delayed-release tablet. Both forms are taken by mouth. Delayed-release drugs are slowly released into the bloodstream over time.

Risedronate is available as the brand-name drugs Actonel (immediate-release tablet) or Atelvia (delayed-release tablet). Both tablets are also available as generic drugs. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug.

Risedronate may be used as part of a combination therapy. This means you may need to take it with other medications. You may also need to take it with calcium or vitamin D supplements. These supplements can help strengthen your bones and help keep them from breaking.

Why it’s used

Risedronate is used to prevent or treat osteoporosis. With this condition, the bones become thin and weak, and break easily. Risedronate is also used to treat Paget’s disease of bone. With this disease, the bones become soft and weak. They may also become deformed or painful, or they may break easily.

How it works

Risedronate belongs to a class of drugs called bisphosphonates. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Risedronate works by slowing the body’s natural breakdown of bone. It also increases the thickness of bone.

Risedronate oral tablet doesn’t cause drowsiness, but it can cause other side effects.

More common side effects

The more common side effects of risedronate can include:

• back pain
• joint pain
• pain in your stomach area
• upset stomach
• diarrhea
• influenza (the flu)

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Ulcers (sores) in your esophagus. Symptoms can include:
• new or worsening heartburn
• trouble swallowing
• pain when swallowing
• chest pain
• bloody vomit
• black or bloody stools
• Bone death of the jaw. Symptoms can include:
• painful or swollen gums
• loosening of the teeth
• numbness or heavy feeling in the jaw
• poor healing after dental surgery or damage to the jaw
• Broken bones. Symptoms can include:
• dull, aching pain in the hip, groin, or thigh

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

Risedronate oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Examples of drugs that can cause interactions with risedronate are listed below.

Interactions that can make your drugs less effective

When risedronate is used with certain drugs, it may not work as well. Examples of these drugs include:

• Calcium supplements or antacids
  • When these drugs are used with risedronate, the amount of risedronate in your body may be reduced. Your doctor may suggest that you take the supplement at a different time of day than when you take risedronate.
• Drugs that lower stomach acid, including proton pump inhibitors (PPIs) and h3 blockers. Examples of these drugs include omeprazole, lansoprazole, esomeprazole, famotidine, and cimetidine
  • When these drugs are used with risedronate delayed-release tablets, they can make the drug enter your bloodstream too quickly. This may keep it from working well. To avoid this, your doctor may switch you to the regular risedronate tablet, or give you a different drug to take for stomach acid.
• Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs)
  • When these drugs are used with risedronate, they can increase your risk of nausea, vomiting, upset stomach, abdominal cramps, diarrhea, and constipation.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

This drug comes with several warnings.

Allergy warning

Risedronate can cause a severe allergic reaction. Symptoms can include:

• trouble breathing
• swelling of your throat or tongue

If you develop these symptoms, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Food interactions warning

Take risedronate only with water. Don’t have juice, coffee, tea, milk, soda, or other drinks with this drug. These drinks can reduce the amount of risedronate your body absorbs. This can keep the drug from working well.

Also, don’t take this drug at the same time that you eat food. If you do, it can increase side effects, as well as make the drug less effective.

Alcohol interaction warning

The use of drinks that contain alcohol can increase your risk of certain side effects from risedronate. These include stomach upset and diarrhea. If you drink alcohol, talk to your doctor about whether this drug is safe for you.

Warnings for people with certain health conditions

For people with an abnormal esophagus: If you have problems with your esophagus, you shouldn’t take risedronate. These problems can include Barrett’s esophagus, stricture, or achalasia.

For people with low calcium blood levels: If you have low calcium blood levels, you should take calcium supplements before you start taking risedronate. Your doctor can tell you more.

For people with kidney problems: If you have severe kidney problems or a history of kidney disease, you shouldn’t take risedronate. Your kidneys clear this drug from your body. If they’re not working well, high levels of this drug can build up in your body. This raises your risk of side effects.

Warnings for other groups

For pregnant women: Risedronate is a category C pregnancy drug. That means two things:

1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should only be used if the potential benefit justifies the potential risk.

If you become pregnant while taking this drug, call your doctor right away.

For women who are breastfeeding: It’s not known whether risedronate passes into breast milk. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For seniors: The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, a higher amount of a drug stays in your body for a longer time. This raises your risk of side effects.

For children: This medication shouldn’t be used in people younger than 18 years.

All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

Dosage for osteoporosis in postmenopausal women (treatment and prevention)

Generic: Risedronate

• Form: oral immediate-release tablet
• Strengths: 5 mg, 30 mg, 35 mg, 75 mg, 150 mg

• Form: oral delayed-release tablet
• Strength: 35 mg

Brand: Actonel

• Form: oral immediate-release tablet
• Strengths: 5 mg, 30 mg, 35 mg, 150 mg

Brand: Atelvia

• Form: oral delayed-release tablet
• Strength: 35 mg

Adult dosage (ages 18–64 years)

For treatment of osteoporosis:

• Typical dosages: Your doctor will prescribe one of the following dosages for you:
• one 5-mg immediate-release tablet daily, OR
• one 35-mg immediate-release tablet or delayed-release tablet per week, OR
• one 75-mg immediate-release tablet taken 2 days in a row, for a total of 2 tablets taken each month, OR
• one 150-mg immediate-release tablet once per month.

For prevention of osteoporosis:

• Typical dosages: Your doctor will prescribe one of the following dosages for you:
• one 5-mg immediate-release tablet daily, OR
• one 35-mg immediate-release tablet per week, OR
• one 75-mg immediate-release tablet taken 2 days in a row, for a total of 2 tablets per month, OR
• one 150-mg immediate-release tablet once per month.

Child dosage (ages 0–17 years)

This medication shouldn’t be used in children younger than 18 years.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, a higher amount of a drug stays in your body for a longer time. This raises your risk of side effects.

Your doctor may start you on a lowered dosage or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Dosage for osteoporosis in men

Generic: Risedronate

• Form: oral immediate-release tablet
• Strengths: 5 mg, 30 mg, 35 mg, 75 mg, 150 mg

Brand: Actonel

• Form: oral immediate-release tablet
• Strengths: 5 mg, 30 mg, 35 mg, 150 mg

Adult dosage (ages 18–64 years)

The typical dosage is one 35-mg tablet per week.

Child dosage (ages 0–17 years)

This medication shouldn’t be used in children younger than 18 years.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, a higher amount of a drug stays in your body for a longer time. This raises your risk of side effects.

Your doctor may start you on a lowered dosage or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Dosage for glucocorticoid-induced osteoporosis

Generic: Risedronate

• Form: oral immediate-release tablet
• Strengths: 5 mg, 30 mg, 35 mg, 75 mg, 150 mg

Brand: Actonel

• Form: oral immediate-release tablet
• Strengths: 5 mg, 30 mg, 35 mg, 150 mg

Adult dosage (ages 18–64 years)

The typical dosage is one 5-mg tablet daily.

Child dosage (ages 0–17 years)

This medication shouldn’t be used in children younger than 18 years.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, a higher amount of a drug stays in your body for a longer time. This raises your risk of side effects.

Your doctor may start you on a lowered dosage or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Dosage for Paget’s disease of bone

Generic: Risedronate

• Form: oral immediate-release tablet
• Strengths: 5 mg, 30 mg, 35 mg, 75 mg, 150 mg

Brand: Actonel

• Form: oral immediate-release tablet
• Strengths: 5 mg, 30 mg, 35 mg, 150 mg

Adult dosage (ages 18–64 years)

The typical dosage is 30 mg daily for 2 months.

Note: In certain cases, repeating treatment with the same dosage and length of therapy may be considered. This may occur if the treatment doesn’t work the first time, or if the disease comes back. A second round of treatment should only be given at least 2 months after the first round.

Child dosage (ages 0–17 years)

This medication shouldn’t be used in children younger than 18 years.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, a higher amount of a drug stays in your body for a longer time. This raises your risk of side effects.

Your doctor may start you on a lowered dosage or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Risedronate oral tablet is used for long-term treatment. It comes with serious risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all: If you don’t take risedronate, your condition may not be controlled. Your risk of broken bones is increased.

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

• upset stomach
• heartburn
• ulcers
• low blood calcium, which can cause muscle cramps or confusion

If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: Take your dose as soon as you remember. But if you remember just a few hours before your next scheduled dose, take only one dose. Never try to catch up by taking two doses at once. This could result in dangerous side effects.

How to tell if the drug is working: You will not feel any different if risedronate is working. Your doctor may do a test called a bone scan to check if the drug is working.

Keep these considerations in mind if your doctor prescribes risedronate for you.

General

• Don’t crush or cut the immediate-release or delayed-release tablets.

Storage

• Store risedronate tablets at room temperature between 68°F and 77°F (20°C and 25°C).
• Don’t store this medication in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They can’t harm your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Self-management

• Take risedronate tablets in the morning.
• Immediate-release tablet: Take this tablet first thing in the morning, with water. Take it at least 30 minutes before your first food, drink (other than water), or medication of the day.
• Delayed-release tablet: Take this tablet right after breakfast, with water. Your risk of stomach pain is higher if you don’t eat breakfast first.
• This drug can irritate your esophagus. To help avoid this:
• Swallow each tablet of risedronate with a full glass of water. This will help make sure the drug reaches your stomach before dissolving.
• Don’t lie down for at least 30 minutes after taking this drug. Also, don’t lie down until after your first food of the day.
• Don’t take risedronate with food. Food is likely to reduce the amount of risedronate your body absorbs. This can keep the drug from working well. It also raises your risk of side effects.
• Take risedronate only with water. Don’t have any other drinks with this drug. Other drinks can reduce the amount of risedronate your body absorbs. This can keep the drug from working well.

Clinical monitoring

Your doctor may monitor your kidney function while you take this drug. Blood tests can check how well your kidneys are working. If your kidneys aren’t working well, your doctor may have you stop taking this drug.

Hidden costs

You may need to have blood tests or a bone scan during your treatment with risedronate. The cost of these tests will depend on your insurance coverage.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

What we know about the effectiveness of risedronate in osteoporosis uMEDp

Osteoporosis (OP) is one of the most common diseases among the elderly, which is characterized by a decrease in mineral density and deterioration of bone quality, resulting in increased bone fragility. The consequences of OP in the form of fractures of the vertebrae and tubular bones cause a significant increase in morbidity, disability and mortality. The lifetime risk of any fracture is about 40% and is equivalent to the risk of cardiovascular disease (1). For women, the risk of hip fracture, the most formidable complication of OP, is 1: 6, while the risk, for example, of breast cancer is 1: 9(2).

Figure 1. Effect of risedronate on the risk of vertebral fracture: results of a 7-year study

In accordance with the international classification of diseases, OP belongs to class 13 – “Diseases of the musculoskeletal system and connective tissue”. In connection with the use of advanced, primarily radiological research methods, the development and implementation of new methods of prevention and treatment, as well as the active and purposeful educational activities of the International Osteoporosis Foundation (IOF) and its 186 National Societies in 9In 0 countries of the world, including the Russian Association for Osteoporosis (RAOP), the social and medical significance of the disease has increased significantly. The official registration of the incidence of OP began in the Russian Federation in 1999, and over the past 10 years (1999-2008), the total number of recorded cases of OP among adult residents of Russia increased by almost 4 times (from 31,500 people in 1999 to 115,530 people . in 2008). The improvement of the technical base for diagnosis had a significant impact on the frequency of detection of the disease, namely, the supply of bone densitometers to medical institutions, which made it possible to measure bone mineral density (BMD) and diagnose OP.

OP develops gradually and is clinically often detected after fractures, which was the basis for calling it a “hidden epidemic”. It should be noted that the frequency of OP increases with age, therefore, the increase in life expectancy observed in recent decades in developed countries and the associated rapid increase in the number of elderly people, especially women, leads to an increase in the frequency of this disease, making it one of the most important health problems in the world. the world.

In 2005, RAOP experts, specialists in various fields of medicine, developed clinical guidelines for the diagnosis, prevention and treatment of OP, including glucocorticoid OP, and in 2009 they were revised and supplemented (3). The recommendations are ranked according to the unified international system of levels of evidence. Despite general recommendations, the treatment of OP in a particular patient is often a difficult task and depends both on the doctor’s interpretation of the patient’s condition and on the patient’s readiness for long-term therapy. The provision of medical care to patients with OP is carried out at the outpatient stage, treatment and observation are long-term, for several years, if secondary causes of the possible development of OP are identified, the patient should be referred for a consultation with a specialist (rheumatologist, endocrinologist, etc.).

Treatment of OP includes both non-pharmacological interventions and drug therapy.

Drug treatment of OP is not an easy task, especially when there are already fractures of various localization in the anamnesis, it should be long-term, and therefore there is a constant search for highly effective and inexpensive drugs. Currently, the range of drugs for the treatment and prevention of OP has expanded significantly, their use reduces the risk of individual fractures by 20-70%. The drugs of the first choice for pathogenetic therapy are nitrogen-containing bisphosphonates (BP), the mechanism of their action is based on the suppression of osteoclast resorption processes and the restoration of bone tissue metabolism to the premenopausal level, which prevents microarchitectural disorders and loss of bone tissue. Today in our country three drugs of this class are already quite well known to doctors – alendronate, ibandronate and zoledronic acid. However, all over the world, along with these drugs, another drug of this class is widely used, which, along with alendronate, is the “gold standard” for the treatment of OP – this is risedronate.

The effectiveness of risedronate in patients with OP has been proven in several randomized clinical double-blind placebo-controlled trials (RCTs). Thus, in two 3-year RCTs in 3684 postmenopausal women with established osteoporosis and a history of vertebral fractures, risedronate was administered daily at doses of 2.5 mg or 5.0 mg simultaneously with 1000 mg of calcium and 500 IU of vitamin D. Within a year treatment, the frequency of new vertebral fractures decreased when taking 5.0 mg by 61-65%, and after 3 years this decrease also remained at a fairly high level – 41-49% compared to control (p

Histological examination of the biopsy material did not reveal a violation of the processes of bone mineralization, as well as damage to the bone marrow when taking 5.0 mg of risedronate. Based on histomorphometric analysis, it was shown that taking this drug reduced bone turnover by almost 50% compared to placebo. Risedronate resulted in a positive balance at the level of the remodeling unit, resulting in an increase in cortical thickness (+20%), while in the placebo group there was a negative trend (-11%) after 3 years of treatment (5).

Tolerability of the drug was satisfactory, it should be noted that the frequency of adverse events (AEs) associated with lesions of the upper gastrointestinal tract (GIT) was similar in all three observation groups. Most of the AEs were mild or moderate in severity, while 35% of the patients included in the study had a history of gastrointestinal diseases (5). There was no increase in the number of these AEs in patients who received non-steroidal anti-inflammatory drugs and aspirin-containing drugs as concomitant treatment. During gastroduodenal endoscopy in patients who received risedronate daily for 3 years, changes in the esophagus, stomach and duodenum were similar to those when taking placebo (6).

A systematic review published in 2008 (7) assessed the efficacy of risedronate in reducing fracture risk based on five meta-analyses pooling ten RCTs and fourteen RCTs that were not included in any of these meta-analyses. A pooled analysis of meta-analyses showed a reduction in the risk of vertebral fractures in postmenopausal women after a year of treatment with 2. 5 mg/day. and 5 mg/day. risedronate versus placebo by 47% (95% CI 23%; 63%) and 62% (95% CI 44%; 75%), respectively. In six studies not included in the meta-analyses, fractures were the primary endpoint. A significant reduction in the risk of vertebral fractures and peripheral fractures with risedronate compared with placebo was shown in four of these studies conducted in populations at high risk of fractures (8-11). One RCT in young military personnel found no reduction in the risk of stress fractures with risedronate prophylaxis compared with placebo (12).

In addition, 3 RCTs have been published comparing different doses of risedronate. The risk of fractures did not differ between groups. However, fractures were assessed as an adverse event in these studies (secondary endpoint) and sample sizes did not allow for differences between groups. Studies that assessed fractures as the primary endpoint, but did not compare different doses of risedronate within the same study, showed a reduction in the risk of all fractures, peripheral fractures and hip fractures at 2. 5 mg / day. and reduced risk of vertebral fractures at doses of 5.0 mg/day. and 35 mg/week. compared to placebo (7).

The effectiveness of risedronate in reducing the risk of fracture in postmenopausal women with osteopenia (BMD by T-score from -1 to -2.5 SD) and without previous vertebral deformities was shown in a retrospective analysis of 4 RCTs. It was found that taking risedronate 5.0 mg for 3 years reduced the risk of any fractures (vertebral and peripheral) by 73% (RR = 0.27, 95% CI 0.09-0.83, p = 0.023) , and in separate analysis, this decrease was 56% for vertebral fractures (p = 0.249), for peripheral fractures – 99% (RR = 0.09, 95% CI 0.01-0.71, p = 0.022) (13).

A study of the aftereffect of risedronate for a year after discontinuation of the drug, although it demonstrated a decrease in BMD in the spine and femoral neck in patients, however, mineral density in these regions remained significantly higher than these indicators when included in the study and higher than in the control group (p

To date, there is evidence of long-term use of risedronate (5 and 7 years) during the extension of a 3-year RCT. Thus, 265 women took risedronate (n = 135) or placebo (n = 130) for 5 years, while the endpoints of the study were not only changes in BMD and bone turnover markers, but also fractures (15). The risk of vertebral fractures in the study drug group was significantly reduced by 59% (95% CI 19-79%, p = 0.01), while the reduction in the risk of peripheral fractures was 41%, however, due to the small number of fractures that occurred, this indicator did not reach the level of statistical significance. After 5 years, during treatment, a further increase in BMD was noted in the spine, which amounted to 9.3%, in the femoral neck – + 2.2%, and the greater trochanter – + 5.7%, while in the placebo group there was bone loss. Risedronate resulted in a reduction in bone resorption markers as early as 3 months of treatment, and this reduction was stable throughout the entire 5-year treatment period. In addition, after 6 months of therapy, a decrease in bone formation markers in the treatment group was recorded and amounted to 18. 4% by the 5th year of observation. In the second extension phase (years 6-7), only 164 women participated, and 136 people completed it, while all patients received risedronate, including the placebo group. During this period, there was a further increase in BMD (for example, in the spine it was 11.5%), markers of bone metabolism remained at the premenopausal level, and the frequency of vertebral fractures did not differ from that in the first phase of extension (6%), which demonstrates the absence of a decrease effectiveness in relation to the risk of fractures compared with 4-5 years of follow-up. At the same time, there was a significant reduction in the risk of vertebral fractures in the second group, which began taking risedronate only after 5 years of follow-up (p = 0.007) (Figure 1) (16).

Several placebo-controlled RCTs have focused on the efficacy of risedronate in glucocorticoid osteoporosis. The largest of them (509 patients) showed a reduction in the risk of vertebral fractures after 12 months. by 58% and 70% when taking 2.5 mg / day. and 5 mg/day. respectively compared to placebo (17).

In 2008, a systematic review of the Cochrane Digital Library was published, evaluating the effectiveness of risedronate 5 mg / day. compared with placebo in postmenopausal women. The meta-analysis included 7 RCTs (14049women). In primary prevention, risedronate did not show an effect on the risk of vertebral and peripheral fractures. Secondary prevention showed a 39% relative risk reduction for vertebral fractures (RR = 0.61, 95% CI 0.50; 0.76) with a 5% absolute risk reduction. There was a significant decrease in the relative risk of peripheral fractures by 20% (RR = 0.80, 95% CI 0.72; 0.90) with a decrease in absolute risk by 2%, and a decrease in the risk of hip fracture by 26% (RR = 0.74 , 95% CI 0.59, 0.94) with a 1% reduction in absolute risk. When primary and secondary prevention studies were pooled, the reduction in fracture risk remained significant for both vertebral fractures (RR = 0. 63, 95% CI 0.51; 0.77) and peripheral fractures (RR = 0.80, 95% CI 0.72; 0.90). None of the analyzed studies identified significant differences in adverse events between groups. However, according to observational data, there is a risk of damage to the upper gastrointestinal tract and, in a very small number of cases, osteonecrosis of the jaw (18).

And another study on the effectiveness of risedronate in relation to peripheral fractures, and in particular, hip fractures, was carried out during an observational study during the first year of treatment in real clinical practice. At the same time, the effectiveness of the well-known drug alendronate in our country was studied using the same parameters (19). For this, 2 cohorts of women aged 65 years and older were formed, one of them was 12215 people who took 35 mg of risedronate 1 time per week, the second (21615 patients) – 70 mg of alendronate according to the same scheme. The incidence of peripheral fractures was 18% lower among those treated with risedronate (2. 0%) compared to those taking alendronate (2.3%), and hip fractures were 43% lower (0.4% and 0.6% respectively). The authors do not exclude the influence of possible systematic errors that occur during this kind of work, for example, in this case, the cohorts initially differed in a number of input characteristics, which could subsequently lead to differences in the frequency of fractures. Therefore, additional statistical processing of the obtained material was carried out, patients with risk factors that could affect the frequency of fractures were excluded from the analysis.
In the end, the results of the study did not change significantly, and the conclusions of this work remained the same.

Thus, the results obtained indicate the effectiveness of risedronate in the treatment of osteoporosis, reducing the risk of fractures and quite satisfactory tolerability.

Risedronate should be taken on an empty stomach immediately after getting out of bed, the tablet should be washed down with 1 glass of clean water, and after taking it should be in an upright position (sitting or standing) for at least 30 minutes. BF can cause side effects associated with damage to the gastrointestinal tract, as well as headache, pain in muscles and bones, a decrease in the level of calcium and phosphorus in the blood serum, and in rare cases, rash and erythema. Compliance with the recommendations for taking the drug significantly reduces the risk of gastrointestinal AEs. Contraindications to their use: hypersensitivity to the drug, severe renal failure (creatinine clearance below 30 ml/min.), hypocalcemia, pregnancy and breastfeeding, children’s age. It should be remembered that taking drugs that affect the pathogenesis of OP, in particular BP, should take place against the background of sufficient intake of calcium and vitamin D from food or in the form of drugs.

The original risedronate was registered in Russia back in 2001, but it is not available in the pharmacy chain. In 2010, a generic risedronate manufactured by Zentiva (Czech Republic) was registered, 35 mg 1 time / week. Conducted studies on the comparability of the action of these two drugs in vitro and in vivo showed their bioequivalence in terms of pharmacokinetics and bioavailability. Thus, today in our country the range of drugs that are successfully used worldwide for the treatment of OP has been expanded.

Treatment of osteoporosis in Israel | Israel Medical Centers Association

Professor Doron Norman

Head of the Orthopedic Unit at the Rambam Hospital. Specialization:
treatment of complex fractures of the lower and upper extremities

Specialization:

ORTHOPEDICS

Doctor’s page

What is osteoparosis

Osteoporosis is a disease characterized by a pathological change in bone tissue, as a result of which the bones become brittle and break easily. Osteoporosis most commonly affects the hips, wrists, and vertebrae.

Bone tissue is constantly renewed. In osteoporosis, new bone cells are rapidly destroyed and do not have time to be replaced by new ones.

The Rambam Medical Center provides comprehensive treatment of osteoporosis using the latest generation of medicines. Clinic specialists continuously monitor the degree of treatment effectiveness and, if necessary, immediately change tactics, choosing more effective drugs.

Symptoms of osteoporosis

As a rule, in the early stages of bone loss, osteoporosis is asymptomatic. The disease begins to manifest itself after a pronounced weakening of the bones. The signs and symptoms of osteoporosis are:

• back pain due to fracture or displacement of the vertebrae;
• gradual decrease in height;
• stoop;
• tendency to fracture.

Causes of osteoporosis

Our bones are constantly being renewed. Old cells are destroyed, they are replaced by new ones. At a young age, new bone cells are produced faster than old ones die off, so there is an increase in bone mass. For most people, peak bone density occurs between 17 and 20 years of age. As we age, bone density decreases.

The risk of osteoporosis depends in part on the highest bone density the patient had in their youth. The higher the peak mass was, the less likely it was to develop osteoporosis with age.

Who is at risk for developing osteoporosis?

There are several groups of factors that increase the risk of developing osteoporosis. These include:

Unchanged risk factors

• Gender – Women are more likely to develop osteoporosis than men.
• Age – As we age, bone loss occurs.
• Genetic predisposition
• Race – Europeans and Asians are more likely to suffer from osteoporosis.

Hormonal risk factors

• Sex hormones – Decreased levels of sex hormones increase the risk of osteoporosis. In women, estrogen levels may decrease during menopause; in men, testosterone levels fall as we age.
• Thyroid hormones – Excess thyroid hormones can cause bone loss.
• Other hormones – Osteoporosis may develop due to overactive parathyroid and adrenal glands.

Dietary risk factors

• Low calcium intake
• Eating disorder
• Stomach or intestinal surgery

Lifestyle risk factors

• Sedentary lifestyle
• Alcohol abuse
• Smoking

Diagnosis of osteoporosis

The detection of osteoporosis in the Rambam Clinic is carried out by measuring bone mineral density. The study can be carried out using a special x-ray, ultrasound or computed tomography.

Treatment of osteoporosis in Rambam

Before starting treatment, Rambam Medical Center experts assess the risk of bone fracture in the next 10 years. The evaluation is based on the results of measuring bone mineral density. If the risk is low, drug therapy is not required. The goal of treatment in this case is lifestyle changes and other measures aimed at safety and elimination of risk factors for bone loss.

At high risk of fractures, drug therapy with drugs of the bisphosphonate group is prescribed. Examples of osteoporosis drugs are alendronate, risedronate, ibandronate, zoledronic acid.

Side effects of bone resorption inhibitors include: nausea, stomach pain, difficulty swallowing, and the risk of inflammation or ulceration of the esophagus. Undesirable effects can be avoided if the drugs are taken correctly. Intravenous forms of bisphosphonates do not cause stomach upset. In some cases, doctors recommend giving intravenous injections several times a year instead of taking daily pills.

Taking bisphosphonates for more than five years is associated with the risk of serious side effects such as subtrochanteric femoral fractures and osteonecrosis of the jaw. Osteonecrosis can occur after tooth extraction. The hole does not heal for a long time, after which the process of death of the jaw bone tissue begins. Therefore, before taking bisphosphonates, Israeli experts recommend that you consult a dentist.

Hormone therapy for osteoporosis

Estrogen therapy, especially during menopause, may help maintain bone density. However, such treatment may increase the risk of thrombosis, endometrial cancer, breast cancer, and cardiovascular disease. In this regard, the treatment of osteoporosis with estrogens is carried out only when a woman needs hormonal treatment of menopause symptoms.

Raloxifene (Evista) is an estrogen analogue that positively affects bone density in postmenopausal women without the associated risks.