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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)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 21, 2004
Last updated: March 31, 2017
Last verified: March 2017
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
Vitamin D Deficiency
Drug: MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, 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
Actual Study Start Date: September 24, 2003
Study Completion Date: May 1, 2004
Primary Completion Date: May 1, 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00092066

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

Study Data/Documents: CSR Synopsis  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00092066     History of Changes
Other Study ID Numbers: 0217A-227
Study First Received: September 21, 2004
Last Updated: March 31, 2017

Additional relevant MeSH terms:
Vitamin D Deficiency
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Deficiency Diseases
Nutrition Disorders
Bone Density Conservation Agents
Physiological Effects of Drugs
Growth Substances processed this record on May 25, 2017