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NCT00092040 Clinical Trial

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

Osteoporosis, Postmenopausal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00092040
Other study ID # 0217-907
Secondary ID 2004_019
Status Completed
Phase Phase 3
First received
Last updated
Start date March 18, 2003
Est. completion date September 28, 2005

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 936
Est. completion date September 28, 2005
Est. primary completion date October 18, 2004
Accepts healthy volunteers No
Gender Female
Age group 40 Years and older
Eligibility Inclusion Criteria: - Postmenopausal women with osteoporosis Exclusion Criteria: - Any known allergy to the study drug

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0217, alendronate sodium/Duration of Intervention: 12 mo

• Comparator: risedronate / Duration of Intervention: 12 mo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Mean percent change from baseline in hip trochanter bone mineral density (BMD)
Secondary Mean percent change from baseline in PA lumbar spine, total hip, and femoral neck BMD
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