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A Study to Evaluate Two Investigational Drugs in Postmenopausal Women With Osteoporosis
This study has been completed.
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00092040
  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 III

MedlinePlus related topics: Minerals Osteoporosis
Drug Information available for: Alendronate Alendronate sodium Risedronate sodium Risedronic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2004_019, MK0217-907
Study First Received: September 21, 2004
Last Updated: March 14, 2008
ClinicalTrials.gov Identifier: NCT00092040  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Calcium, Dietary
Musculoskeletal Diseases
Alendronate
Osteoporosis, Postmenopausal
 Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Risedronic acid

Additional relevant MeSH terms:
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
 Calcium Channel Blockers
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009



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