A Study and 12 Month Extension to Evaluate Two Investigational Drugs in Postmenopausal Women With Osteoporosis (MK-0217-907)
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
2 other identifiers
interventional
936
0 countries
N/A
Brief Summary
The purpose of this study and 12 month extension is to evaluate the effects of two investigational drugs on osteoporosis in postmenopausal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2003
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2003
CompletedFirst Submitted
Initial submission to the registry
September 21, 2004
CompletedFirst Posted
Study publicly available on registry
September 24, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2005
CompletedAugust 14, 2024
February 1, 2022
1.6 years
September 21, 2004
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Mean percent change from baseline in hip trochanter bone mineral density (BMD)
Secondary Outcomes (1)
Mean percent change from baseline in PA lumbar spine, total hip, and femoral neck BMD
Interventions
Eligibility Criteria
You may qualify if:
- Postmenopausal women with osteoporosis
You may not qualify if:
- Any known allergy to the study drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (2)
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. doi: 10.2165/00044011-200626020-00002.
PMID: 17163237BACKGROUNDReid 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.
PMID: 18324951BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2004
First Posted
September 24, 2004
Study Start
March 18, 2003
Primary Completion
October 18, 2004
Study Completion
September 28, 2005
Last Updated
August 14, 2024
Record last verified: 2022-02