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)

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.

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 significant medical conditions that are not adequately treated

Treatment and study plan

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

Drug

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.

Sponsors and collaborators

Lead sponsor

Organon and Co

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: 2003
Primary completion: 2004
Study completion: 2004
First posted: Sep 24, 2004
Registry last updated: Aug 14, 2024

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