Actonel vs Atelvia: Comparing Risedronate Sodium Medications for Osteoporosis Treatment

19.09.202327.06.2023 by alexxlab

How do Actonel and Atelvia differ in their formulation and administration. What are the key benefits and drawbacks of these risedronate sodium medications for osteoporosis. Which patients may be better suited for Actonel vs Atelvia based on their specific needs.

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Understanding Risedronate Sodium: The Active Ingredient in Actonel and Atelvia

Risedronate sodium is the active pharmaceutical ingredient found in both Actonel and Atelvia. It belongs to a class of drugs called bisphosphonates, which are commonly prescribed for the treatment and prevention of osteoporosis. Bisphosphonates work by slowing down bone loss and increasing bone density, thereby reducing the risk of fractures in individuals with weakened bones.

Are bisphosphonates the most frequently prescribed osteoporosis medications? Indeed, oral bisphosphonate drugs, including alendronate (Fosamax), risedronate (Actonel and Atelvia), and ibandronate (Boniva), are the most commonly prescribed treatments for osteoporosis. Their popularity stems from their relatively low cost, long-term safety profile, and proven effectiveness in preventing fractures.

Actonel: The Original Risedronate Sodium Formulation

Actonel has been a staple in osteoporosis treatment for many years. It is typically prescribed as a daily, weekly, or monthly oral medication. The standard dosing regimen requires patients to take the medication on an empty stomach with water and remain upright for at least 30 minutes afterward to minimize the risk of esophageal irritation.

Can Actonel be taken with food? No, Actonel should be taken on an empty stomach, at least 30 minutes before the first food or drink of the day (other than water). This requirement is due to the fact that food can interfere with the absorption of the medication, potentially reducing its effectiveness.

Advantages of Actonel

Proven track record in osteoporosis treatment
Available in multiple dosing options (daily, weekly, monthly)
Generally well-tolerated by most patients
Extensive research data available on long-term use

Potential Drawbacks of Actonel

Strict administration requirements (fasting, remaining upright)
Possible gastrointestinal side effects
Risk of esophageal irritation if not taken properly
May not be suitable for patients with kidney problems

Atelvia: The Next Generation of Risedronate Sodium

Atelvia, approved by the FDA in 2010, represents a new formulation of risedronate sodium. The key innovation of Atelvia lies in its delayed-release coating, which allows for a different administration protocol compared to traditional bisphosphonates like Actonel.

How does Atelvia’s delayed-release formulation benefit patients? The delayed-release coating of Atelvia enables patients to take the medication immediately after breakfast, eliminating the need for fasting. This can significantly improve patient compliance and reduce the risk of gastrointestinal side effects associated with taking bisphosphonates on an empty stomach.

Advantages of Atelvia

Can be taken immediately after breakfast
May improve patient compliance due to easier administration
Potentially reduced risk of gastrointestinal side effects
Eliminates the need for fasting before taking the medication

Potential Drawbacks of Atelvia

Limited long-term data compared to Actonel
May be more expensive than generic risedronate options
Still requires patients to remain upright for at least 30 minutes after taking
Not suitable for patients with certain gastrointestinal conditions

Comparing Efficacy: Actonel vs Atelvia in Osteoporosis Treatment

When it comes to efficacy in treating osteoporosis, both Actonel and Atelvia contain the same active ingredient, risedronate sodium. Therefore, their effectiveness in increasing bone density and reducing fracture risk is generally considered to be equivalent.

Do Actonel and Atelvia have different success rates in clinical trials? Clinical trials have shown similar efficacy between Actonel and Atelvia in terms of increasing bone mineral density and reducing the risk of vertebral and non-vertebral fractures. The primary difference lies in their formulation and administration, rather than their effectiveness in treating osteoporosis.

Key Findings from Clinical Studies

Both medications significantly increase bone mineral density in the spine and hip
Risedronate sodium has been shown to reduce the risk of vertebral fractures by up to 49% over three years
Non-vertebral fracture risk reduction of approximately 36% has been observed with risedronate treatment
The medications demonstrate similar efficacy in postmenopausal women and men with osteoporosis

Patient Considerations: Choosing Between Actonel and Atelvia

The choice between Actonel and Atelvia often comes down to individual patient factors and preferences. Healthcare providers consider several aspects when recommending one formulation over the other.

Which patients might benefit more from Atelvia’s unique formulation? Atelvia may be particularly beneficial for patients who have difficulty complying with the fasting requirements of traditional bisphosphonates, those with a history of gastrointestinal issues, or individuals who prefer to take their medication with food. However, it’s essential to consult with a healthcare provider to determine the most appropriate option based on individual circumstances.

Factors Influencing Medication Choice

Patient’s ability to comply with fasting requirements
History of gastrointestinal issues or sensitivity
Preference for taking medication with or without food
Cost considerations and insurance coverage
Presence of other medical conditions or medications

Side Effects and Safety Profile: Actonel vs Atelvia

As both Actonel and Atelvia contain the same active ingredient, their overall side effect profiles are similar. However, the delayed-release formulation of Atelvia may offer some advantages in terms of gastrointestinal tolerability.

Are there any unique side effects associated with Atelvia’s delayed-release formulation? While the overall side effect profile is similar to Actonel, some patients may experience fewer gastrointestinal side effects with Atelvia due to its ability to be taken with food. However, both medications can potentially cause side effects such as bone, joint, or muscle pain, and in rare cases, more serious complications like osteonecrosis of the jaw or atypical femur fractures.

Common Side Effects of Risedronate Sodium

Stomach pain or upset
Nausea
Diarrhea
Constipation
Headache
Dizziness
Flu-like symptoms

Rare but Serious Side Effects

Osteonecrosis of the jaw
Atypical femur fractures
Severe bone, joint, or muscle pain
Esophageal ulcers (more common with Actonel than Atelvia)

Alternative Treatments for Osteoporosis

While bisphosphonates like Actonel and Atelvia are commonly prescribed for osteoporosis, they may not be suitable or effective for all patients. In such cases, healthcare providers may consider alternative treatments.

What options are available for patients who cannot tolerate or do not respond to bisphosphonates? Several alternatives exist for osteoporosis treatment, including denosumab (Prolia), teriparatide (Forteo), and raloxifene (Evista). Each of these medications works differently and may be more appropriate for certain patients based on their specific needs and medical history.

Alternative Osteoporosis Treatments

Denosumab (Prolia): A monoclonal antibody given as a subcutaneous injection every six months
Teriparatide (Forteo): A synthetic form of parathyroid hormone administered via daily subcutaneous injections
Raloxifene (Evista): A selective estrogen receptor modulator taken orally
Zoledronic acid (Reclast): An intravenous bisphosphonate administered once a year
Abaloparatide (Tymlos): A synthetic peptide analog of parathyroid hormone-related protein

The Future of Osteoporosis Treatment: Beyond Actonel and Atelvia

As research in the field of osteoporosis continues to advance, new treatments and formulations are being developed to address the limitations of current therapies and provide more personalized options for patients.

What emerging therapies show promise in osteoporosis treatment? Several innovative approaches are being explored, including new anabolic agents that stimulate bone formation, combination therapies that target both bone resorption and formation, and novel drug delivery systems that could improve efficacy and reduce side effects. Additionally, researchers are investigating the potential of gene therapies and stem cell treatments for osteoporosis.

Promising Areas of Research

Sclerostin inhibitors to promote bone formation
Cathepsin K inhibitors for more targeted bone resorption inhibition
Dual-action therapies combining anabolic and anti-resorptive effects
Nanotechnology-based drug delivery systems
Gene therapies targeting specific pathways in bone metabolism
Stem cell treatments to regenerate bone tissue

As the landscape of osteoporosis treatment continues to evolve, patients and healthcare providers will have access to an increasingly diverse array of options. While Actonel and Atelvia remain important tools in the management of osteoporosis, ongoing research promises to deliver even more effective and personalized treatments in the future. It is crucial for individuals with osteoporosis to work closely with their healthcare providers to determine the most appropriate treatment plan based on their specific needs, medical history, and the latest available evidence.

Mayo Clinic Q and A: Finding the right osteoporosis medication

By
Liza Torborg
October 13, 2017

DEAR MAYO CLINIC: The bisphosphonate drugs I take for osteoporosis aren’t working in my case. My doctor has suggested a few alternatives. Any thoughts on what might be best?

ANSWER: Oral bisphosphonate drugs — including alendronate (Fosamax), risedronate (Actonel and Atelvia) and ibandronate (Boniva) — are the most commonly prescribed osteoporosis drugs. Bisphosphonates are less expensive than the alternatives, are safe in the long term, and are effective in preventing fractures. Still, some women aren’t sufficiently helped by bisphosphonates, and some can’t take them due to issues with swallowing, stomach upset, heartburn, low-functioning kidneys, or other side effects, such as bone or muscle aches.

In recent years, the drug denosumab (Prolia) has emerged as an alternative to bisphosphonates for the treatment of postmenopausal osteoporosis. Denosumab may be considered a first-line treatment for women with osteoporosis who are at high risk of fracture or in women who can’t take bisphosphonates. Since denosumab isn’t metabolized by the kidneys, it’s also a first-line option for women with more advanced chronic kidney disease.

When it comes to improving bone density and reducing fracture risk, denosumab may provide better results than do bisphosphonates. As with bisphosphonates, it has a small risk of serious side effects, such as skin infections, headache and fatigue. For people with osteoporosis, the risk of a condition in which the jawbone doesn’t heal following an injury, such as having a tooth pulled (osteonecrosis of the jaw), appears to be lower with denosumab than it is with bisphosphonates. Long-term use of denosumab over eight years has been shown to be both safe and effective. Still, denosumab may not be covered by insurance, unless a trial of bisphosphonate drugs has been attempted.

Denosumab is given by an injection just under the skin (subcutaneously) every six months, meaning you don’t need to remember to take your osteoporosis pills, and it won’t bother your digestive system. The bisphosphonate drug zoledronic acid (Reclast), another option, can be given once a year by intravenous infusion.

Other drugs occasionally used to treat osteoporosis include teriparatide (Forteo), a drug often reserved for the treatment of severe osteoporosis. It requires daily subcutaneous injections. Oral raloxifene (Evista) isn’t as effective in preventing fractures as either bisphosphonates or denosumab, but there are very select situations when these drugs may be considered. (adapted from Mayo Clinic Health Letter) — Dr. Kurt Kennel, Endocrinology, Mayo Clinic, Rochester, Minnesota

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Atelvia: My Review – Save Our Bones

Atelvia (risedronate sodium), an oral bisphophonate made by Warner Chilcott, has been approved in the US on October 8, 2010. Here’s the simple trick used for creating Atelvia: clever marketing sleight of hand.

Let me explain.

Atelvia’s active ingredient is identical to its twin Actonel, and similar to its cousins Fosamax (including the generic alendronate) and Boniva (ibandronate).

So what’s Atelvia’s new twist? It comes in the form of a delayed-release coating which eliminates the fasting requirements applicable to the other bisphosphonate drugs.

It’s like a car salesman desperately trying to sell an old, beat up, and unsafe car with a new paint job as a “new” car.

Masters of Disguise

Based on its delayed release formulation, Atelvia was awarded its own patent and joined the rest of the bisphophonate family in October 2010.

Part of my research routine is to closely monitor new osteoporosis drug developments as well as patent expirations for existing drugs.

Actonel was especially on my radar, since its patent was about to expire on 2011, until it received an extension for another three years. Actonel’s future didn’t look too bright. According to the drug’s manufacturer Warner Chilcott, the total filled prescriptions for Actonel in the US declined by almost 22% in the first quarter of 2010 as compared to the same period in 2009.¹

But now, thanks to Atelvia’s patent protection awarded in the US until the year 2026, Actonel’s active ingredient risedronate has regained new longevity.

And I couldn’t help but laugh when I recently caught a glimpse of Atelvia’s television ad during a brief break. The ad seems to spoof Boniva, depicting it as an “inconvenient” osteoporosis drug because of having to wait at least one hour to have breakfast after taking it. And it attempts to send the clear message that Atelvia is the “smart” woman’s choice for osteoporosis because it eliminates the wait to eat or drink. Well, we in the Save Our Bones community know better.

Same Old Formula, Same Terrible Side Effects

Atelvia has the exact same side effects as Actonel and the rest of the oral bisphosphonates. Hardly a “smart” way to tackle osteoporosis! You may already know the long list of undesirable side effects of bisphosphonates, but here’s a refresher. As I write in the Osteoporosis Reversal Program, the most common side effects are:

Nausea
Inflammation and ulceration of the esophagus
Chest pain, heartburn or difficulty swallowing
Abdominal cramping
Flatulence
Skin rash
Blurred vision
Generalized pain of the muscles, joints and/or bones
Decreased mobility of joints

And of course, let’s not forget the increased risk of atrial fibrillation, esophageal cancer, blood clotting disorders, anemia, and the horrendous and irreversible osteonecrosis of the jaw. But that’s not all, because there’s…

A New Addition to the List

According to a study published in the Journal of Bone and Mineral Research, using bisphosphonates for at least five years increases the risk for atypical femoral fractures. It reviewed 310 cases of atypical femur fractures and found that a staggering 291 (94%) had taken the drugs for more than five years.²

But the researchers were quick to point out that they don’t recommend stopping the use of these drugs because the benefits appear to outweigh the risks.

In view of this new problem, what is the medical establishment’s best solution? Nothing more than to include a warning about femur fractures on all bisphosphonate drugs!

Watch the two minute video below with the study findings and recommendations, which also apply to Atelvia:

Surprised?

You shouldn’t be. As I explain in great detail on this website and in the Osteoporosis Reversal Program, bisphosphonates alter the natural bone remodeling cycle, which affects bone quality, making it more susceptible to fracture.

Fortunately, common sense is slowly but surely filtering through to mainstream medicine. Two studies have recently revealed that long-term suppression of bone remodeling can adversely affect the bone’s mechanical integrity. ³

Researchers are finally recognizing what we have been saying here all along: that while bisphosphonates can affect bone quantity, they actually hurt bone quality.

Take a look at the X-rays of atypical femur fractures below, published in the same study. You can clearly see the fracture line right across the bone:

Source: JAMA

The good news is that you have found this website, and that you are part of the Save Our Bones Community. You’re already on the right path. Stay with us, explore the website, and I’ll continue to do my best to keep you up-to-date and well informed, as we continue on this “health journey” together.

References

¹https://www.morningstar.com/earnings/13798854-warner-chilcott-limited-wcrx-q1-2010.aspx?pindex=1
²Shane E. et al. Atypical subtrochanteric and diaphyseal femoral fractures: report of a task force of the American Society for Bone and Mineral Research. J. Bone Miner Res. 2010 Nov;25(11):2267-94.
³Kuehn B M. Studies Probe Possible Link Between Bisphosphonates and Femoral Fractures. JAMA. 2010;303(18):1795-1796.

Atelvia instructions, description and reviews

Pronunciation

Common name: risedronate (rih SED ro nayt)
Names marks : Actonel, Atelvia

Atelvia (risedron ate) belongs to a group of drugs called bisphosphonates (bis FOS fo nayts). Risedronate reverses the cycle of bone formation and destruction in the body. Risedronate slows down bone loss while increasing bone mass, which may prevent bone fractures.

Atelvia delayed release is a prescription medicine used to treat osteoporosis in postmenopausal women.

Atelvia may also be used for purposes not listed in this medication guide.

You should not use Atelvia if you have low blood calcium levels (hypocalcemia) or a problem with muscle movement in your esophagus.

Slideshow Joint Effort: Provider’s Guide to Orthopedic Pain Options

Do not take Atelvia Tablet if you cannot sit upright or stand for at least 30 minutes. Risedronate can cause serious problems in the stomach or esophagus (the tube that connects the mouth and stomach).

You should not use Atelvia if you are allergic to risedronate, or if you have:

Do not take Atelvia tablet if you cannot sit upright or stand for at least 30 minutes. Risedronate can cause serious problems in the stomach or esophagus (the tube that connects the mouth and stomach). You will need to remain upright for at least 30 minutes after taking this medication.

To make sure Atelvia is safe for you, tell your doctor if you have:

Rarely, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing from dental work. The longer you use Atelvia, the more likely you are to develop this condition.

Osteonecrosis of the jaw may be more likely if you have cancer or chemotherapy, radiation, or steroids. Other risk factors include clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

Talk to your doctor about the risks and benefits of using this medication.

It is not known if Atelvia will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether risedronate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breastfeeding a baby.

Take Atelvia exactly as prescribed by your doctor. Follow all directions on the prescription label. Do not take this medicine in larger or smaller amounts, or for longer than recommended.

Take an Atelvia tablet once a week, immediately after breakfast, with at least 4 ounces of plain water. Take the tablet on the same day and every week.

When using an Atelvia tablet, use plain water only (not mineral water).

Follow these instructions carefully after taking an Atelvia tablet:

Do not lie down or recline for at least 30 minutes after taking Atelvia.
Do not eat or drink anything other than plain water.
Do not take any other medications, including vitamins, calcium, or antacids, for at least 30 minutes after taking Atelvia. It is best to take your other medicines at other times of the day. Talk to your doctor about the best dosing schedule for your other medications.

Do not crush, cut, chew, or suck on an Atelvia tablet. Swallow it all. The tablet is specially coated to protect your stomach. Breaking the tablet can damage this coating.

If you need dental work (especially surgery), let your dentist know in advance that you are using Atelvia. You may need to stop using the medicine for a short time.

To be sure this medicine is helping your condition, your bone mineral density should be checked regularly. You may not need to take Atelvia for more than 3 to 5 years if you are taking it for osteoporosis.

Atelvia is only part of a complete treatment program that may also include dietary changes, exercise, and calcium and vitamin supplements. Watch your diet, medications, and exercise very carefully.

Store at room temperature away from moisture and heat.

See also: Dosing Information (more details)

If you forget to take Atelvia on your scheduled date, do so first thing in the morning the next day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take two (2) tablets in one day.