Atelvia (Risedronate Sodium Hemi-Pentahydrate / Risedronate Sodium Monohydrate) - Summary

ATELVIA SUMMARY

Atelvia (risedronate sodium) delayed-release tablets contain a pH-sensitive enteric coating and a chelating agent (EDTA). Risedronate is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each Atelvia tablet for oral administration contains the equivalent of 35 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The empirical formula for risedronate sodium hemi-pentahydrate is C₇H₁₀NO₇P₂Na •2.5 H₂O.

Postmenopausal Osteoporosis

Atelvia is indicated for the treatment of osteoporosis in postmenopausal women. Bone mineral density increases achieved at one year with Atelvia are non-inferior to increases seen with risedronate sodium 5 mg (immediate-release) daily. Daily risedronate sodium 5 mg (immediate-release) has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [ see Clinical Studies ].

Important Limitations of Use

The safety and effectiveness of Atelvia for the treatment of osteoporosis are based on clinical data of one year duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.

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NEWS HIGHLIGHTS

Published Studies Related to Atelvia (Risedronic Acid / Risedronic Acid)

Anti-fracture efficacy of risedronic acid in men: A meta-analysis of randomized controlled trials. [2009]
BACKGROUND AND OBJECTIVE: Male osteoporosis is an important public health issue and remains undertreated. We performed this meta-analysis to clarify the anti-fracture efficacy of risedronic acid in men... CONCLUSION: The results of this meta-analysis show that risedronic acid treatment is associated with a reduced risk of fractures in men.

Alendronic acid produces greater effects than risedronic acid on bone density and turnover in postmenopausal women with osteoporosis : results of FACTS -international. [2006]
BACKGROUND: The objective of the study was to evaluate the effects of alendronic acid once weekly relative to risedronic acid once weekly on bone mineral density (BMD), markers of bone turnover and tolerability in the treatment of osteoporosis in postmenopausal women... CONCLUSIONS: Alendronic acid once weekly produced greater BMD increases at both hip and spine sites and greater reductions in bone turnover relative to risedronic acid once weekly. Both agents were well tolerated with no significant difference in upper gastrointestinal adverse experiences. Clinicians should consider these results when making treatment decisions for postmenopausal women with osteoporosis.

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Clinical Trials Related to Atelvia (Risedronic Acid / Risedronic Acid)

Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone [Recruiting]

A Study to Show That Treatment With Denosumab is as Good as Treatment With Risedronate in Subjects Who Are Starting to Take or Currently Taking Glucocorticoids. [Recruiting]
This study is being conducted in patients taking glucocorticoids for treatment of various diseases. It is a 2-year study that will compare the effects of denosumab and risedronate.

Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis [Recruiting]
The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis.

IGF-1 and Bone Loss in Women With Anorexia Nervosa [Recruiting]
Anorexia nervosa is an eating disorder that can cause thinning of the bones (a decrease in bone density). A significant decrease in bone density is called osteopenia or osteoporosis. Sometimes the loss of bone density can be severe enough to cause breaks and fractures of the bones. It is not known what causes the bones to thin in anorexia nervosa. Women who have this condition often have thin or weak bones that are more likely to break. They also have very low levels of a chemical called IGF-1 in their body. This chemical is very important for increasing bone growth in puberty and for maintaining healthy adult bones. The investigators would like to find out if giving rhIGF-1 followed by risedronate or risedronate alone can lead to an increase in bone formation, bone density, and bone strength in women with anorexia nervosa.

Effect of Actonel on Periodontal Health of Postmenopausal Women [Recruiting]
Hypothesis: Women who use Actonel (risedronate) for osteopenia will show beneficial periodontal effects.

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Reports of Suspected Atelvia (Risedronic Acid / Risedronic Acid) Side Effects

Arthralgia (15),  Back Pain (9),  Abdominal Pain (8),  Myalgia (8),  Headache (7),  Pyrexia (6),  Influenza Like Illness (6),  Abdominal Pain Upper (6),  Flatulence (5),  Pain (5), more >>