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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

717 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-24

Study Completion Date

2004-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoporosis Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No