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)

Phase 3CompletedNCT00092066

Organon and Co717 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 the treatment of osteoporosis in men and postmenopausal women.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

717

Conditions

Osteoporosis Vitamin D Deficiency

Interventions

MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 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 significant medical conditions that are not adequately treated

Outcomes

Primary Outcomes

Proportion of patients with Vitamin D insufficiency (defined as serum 25-hydroxyvitamin levels <15 ng/mL) after 15 weeks of treatment.

Secondary Outcomes

Proportion of patients with vitamin D deficiency (serum 25-hydroxyvitamin D levels <9 ng/mL) after 15 weeks of treatment.

Data from ClinicalTrials.gov

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