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

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.

Completed

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Key information

Conditions

Osteoporosis Avitaminosis Bone Diseases Bone Diseases, Metabolic Deficiency Diseases Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2004
Primary completion: 2004
Study completion: 2004
First posted: Sep 24, 2004
Registry last updated: Nov 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed