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)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092066
First received: September 21, 2004
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Vitamin D Deficiency
Drug: MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

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

Enrollment: 717
Study Start Date: September 2003
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092066

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092066     History of Changes
Other Study ID Numbers: 0217A-227, 2004_020
Study First Received: September 21, 2004
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Vitamin D Deficiency
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Alendronate
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 16, 2014