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)

Organon

Status and phase: Completed; Phase 3

Conditions: Osteoporosis; Vitamin D Deficiency

Treatments: Drug: MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092066

2004_020

0217A-227

Details and patient eligibility

About

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.

Enrollment: 717 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or postmenopausal women who are osteoporotic

Exclusion criteria

• Vitamin D deficiency
• Other disease of bone or mineral metabolism
• Digestive disease causing malabsorption
• Other significant medical conditions that are not adequately treated

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind