A Study to Evaluate Two Investigational Drugs in Postmenopausal Women With Osteoporosis

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00092040

First received: September 21, 2004

Last updated: January 21, 2010

Last verified: January 2010

History of Changes

Purpose

The purpose of this study is to evaluate the effects of two investigational drugs on osteoporosis in postmenopausal women.

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

Mean percent change from baseline in hip trochanter bone mineral density (BMD)

Secondary Outcome Measures:

Mean percent change from baseline in PA lumbar spine, total hip, and femoral neck BMD

Estimated Enrollment:	760
Study Start Date:	March 2003

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal women with osteoporosis

Exclusion Criteria:

Any known allergy to the study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092040

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Reid DM, Hosking D, Kendler D, Brandi ML, Wark JD, Weryha G, Marques-Neto JF, Gaines KA, Verbruggen N, Melton ME. Alendronic acid produces greater effects than risedronic acid on bone density and turnover in postmenopausal women with osteoporosis : results of FACTS -international. Clin Drug Investig. 2006;26(2):63-74.

Reid DM, Hosking D, Kendler D, Brandi ML, Wark JD, Marques-Neto JF, Weryha G, Verbruggen N, Hustad CM, Mahlis EM, Melton ME. A comparison of the effect of alendronate and risedronate on bone mineral density in postmenopausal women with osteoporosis: 24-month results from FACTS-International. Int J Clin Pract. 2008 Apr;62(4):575-84.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00092040 History of Changes
Other Study ID Numbers:	2004_019, MK0217-907
Study First Received:	September 21, 2004
Last Updated:	January 21, 2010
Health Authority:	United States: Institutional Review Board

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 19, 2013

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