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)
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.
Vitamin D Deficiency
Drug: MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 weeks
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A 15-Week, Double-Blind, Randomized, Active-Controlled, Multi-Center Study With 24-Week Extension to Evaluate the Safety, Tolerability, Efficacy of Alendronate 70 mg Plus Vitamin D3 2800 IU Combination Tablet in Men and Postmenopausal Women With Osteoporosis|
- Proportion of patients with Vitamin D insufficiency (defined as serum 25-hydroxyvitamin levels <15 ng/mL) after 15 weeks of treatment.
- Proportion of patients with vitamin D deficiency (serum 25-hydroxyvitamin D levels <9 ng/mL) after 15 weeks of treatment.
|Study Start Date:||September 2003|
|Study Completion Date:||May 2004|
|Primary Completion Date:||May 2004 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092066
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|