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)

Study Comparing Bone Loss in Women Who Take Calcium and Vitamin D With Women Who Also Take Risedronate or Exercise [Recruiting]
The purpose of this study is to identify the best way to prevent bone loss in the first years after menopause. The HOPE study will compare bone loss at 12 months in women: 1) who take calcium and vitamin D only; 2) who take calcium and vitamin D plus the medication "risedronate"; or 3) who take calcium and vitamin D plus participate in bone-loading exercises. Our central hypothesis is that improvements in bone health will be greater in women randomized to bone-loading exercises with calcium and vitamin D compared to women who take calcium and vitamin D only or women who take calcium and vitamin D plus risedronate.

A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets [Active, not recruiting]
The present phase II/III, multicenter, randomized, double-blind, parallel group comparative study is designed to evaluate the efficacy and safety of oral administration of NE-58095NF(New formulation) tablets for 12 months in patients with involutional osteoporosis. For this study, patients receiving oral NE-58095 2. 5-mg tablets once daily for 12 months are set as the control group.

Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use [Completed]
The purpose of the study is to learn if one year of treatment with parathyroid hormone (PTH), either alone or with risedronate, will increase the thickness of the bones in the hip and spine in subjects with osteoporosis from chronic low dose steroid use. During the second year, the study will also look at whether taking risedronate will preserve the bone thickness created by one year of rhPTH 1-34 treatment.

Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer [Completed]
Prostate cancer patients treated with LHRH agonists (e. g., leuprolide) lose bone mineral density. This is similar to post-menopausal osteoporosis. Risedronate is approved to prevent osteoporosis. We hypothesize that risedronate may also be effective in prostate cancer patients treated with LHRH agonists.

Assess the Influence of a High-fat Meal on the Relative Bioavailability Of Two Formulations of Risedronate [Completed]
This is a randomized, open-label, multi-center, 4-treatment, 4-period crossover study. Approximately 72 healthy, surgically sterile or postmenopausal subjects will be enrolled and have urine collected over 72 hours following administration of risedronate for all 4 treatment periods).

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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 >>