A Study of MK0217A and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)

Phase 3CompletedNCT00092079

Merck Sharp & Dohme LLC652 enrolled

Overview

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 treatment of osteoporosis in men and postmenopausal women.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

652

Conditions

Osteoporosis Vitamin D Deficiency

Interventions

MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 24 weeksDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

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 medical conditions that are not adequately treated

Outcomes

Primary Outcomes

Safety and tolerability; primary parameter assessed is the proportion of patients who develop hypercalcuria

Data from ClinicalTrials.gov

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