A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
NCT00092066 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 717
Last updated 2024-08-14
Summary
The purpose of this study is to test the safety, tolerability and effectiveness of an investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and deficiency during the treatment of osteoporosis in men and postmenopausal women.
Conditions
- Osteoporosis
- Vitamin D Deficiency
Interventions
- DRUG
-
MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 weeks
Sponsors & Collaborators
-
Organon and Co
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-09-24
- Primary Completion
- 2004-05-01
- Completion
- 2004-05-01
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