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A Study and 12 Month Extension to Evaluate Two Investigational Drugs in Postmenopausal Women With Osteoporosis (MK-0217-907)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis, Postmenopausal

Intervention: MK0217, alendronate sodium/Duration of Intervention: 12 mo (Drug); Comparator: risedronate / Duration of Intervention: 12 mo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

The purpose of this study and 12 month extension is to evaluate the effects of two investigational drugs on osteoporosis in postmenopausal women.

Clinical Details

Official title: 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; 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

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

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Postmenopausal women with osteoporosis

Exclusion Criteria:

- Any known allergy to the study drug

Locations and Contacts

Additional Information

Related 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. doi: 10.1111/j.1742-1241.2008.01704.x.

Starting date: March 2003
Last updated: February 26, 2015

Page last updated: August 20, 2015

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