A Study to Evaluate and Compare the Effects of Two Approved Drugs in Women With Postmenopausal Osteoporosis - Full Text View

Purpose

This study is to evaluate and compare the effects of two approved medications to treat women with postmenopausal osteoporosis.

Condition	Intervention	Phase
Postmenopausal Osteoporosis	Drug: MK0217, alendronate sodium/Duration of Treatment: 12 mo Drug: Comparator: risedronate/Duration of Treatment: 12 mo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A 12-Month Extension to: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Once Weekly Alendronate and Risedronate on Bone Mineral Density in Postmenopausal Women With Osteoporosis

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Minerals Osteoporosis

Drug Information available for: Risedronate sodium Alendronate sodium

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

To evaluate the mean percent change from baseline in hip trochanter bone mineral density (BMD) at 24 months

Secondary Outcome Measures:

Evaluate mean % change from baseline in: total hip/femoral neck/PA lumbar BMD at 24 mo and biochemical markers of bone turnover at 24 mo
Evaluate overall safety & tolerability
Assess % of responders at 24 mo

Estimated Enrollment:	900
Study Start Date:	February 2002

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women with postmenopausal osteoporosis

Exclusion Criteria:

Bilateral hip replacements
Esophageal abnormalities
Metabolic bone disease (example - vitamin D deficiency)
Medications that would affect the breakdown or build-up of bone turnover

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092014

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Rosen CJ, Hochberg MC, Bonnick SL, McClung M, Miller P, Broy S, Kagan R, Chen E, Petruschke RA, Thompson DE, de Papp AE; Fosamax Actonel Comparison Trial Investigators. Treatment with once-weekly alendronate 70 mg compared with once-weekly risedronate 35 mg in women with postmenopausal osteoporosis: a randomized double-blind study. J Bone Miner Res. 2005 Jan;20(1):141-51. Epub 2004 Sep 29.

Sebba AI, Bonnick SL, Kagan R, Thompson DE, Skalky CS, Chen E, de Papp AE; Fosamax Actonel Comparison Trial investigators. Response to therapy with once-weekly alendronate 70 mg compared to once-weekly risedronate 35 mg in the treatment of postmenopausal osteoporosis. Curr Med Res Opin. 2004 Dec;20(12):2031-41. Erratum in: Curr Med Res Opin. 2005 Feb;21(2):325.

Bonnick S, Saag KG, Kiel DP, McClung M, Hochberg M, Burnett SA, Sebba A, Kagan R, Chen E, Thompson DE, de Papp AE. Comparison of weekly treatment of postmenopausal osteoporosis with alendronate versus risedronate over two years. J Clin Endocrinol Metab. 2006 Jul;91(7):2631-7. Epub 2006 Apr 24.

Burnett-Bowie SA, Saag K, Sebba A, de Papp AE, Chen E, Rosenberg E, Greenspan SL. Prediction of changes in bone mineral density in postmenopausal women treated with once-weekly bisphosphonates. J Clin Endocrinol Metab. 2009 Apr;94(4):1097-103. Epub 2009 Jan 13.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00092014 History of Changes
Other Study ID Numbers:	2004_016, MK0217-211
Study First Received:	September 21, 2004
Last Updated:	January 21, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Alendronate
Bone Density Conservation Agents

Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013