A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis
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|