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Clinical Trials/NCT00092079
NCT00092079
Completed
Phase 3

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

Merck Sharp & Dohme LLC0 sites652 target enrollmentJanuary 2004
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ConditionsOsteoporosisVitamin D Deficiency
DrugsMK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 24 weeks

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Osteoporosis
Sponsor
Merck Sharp & Dohme LLC
Enrollment
652
Primary Endpoint
Safety and tolerability; primary parameter assessed is the proportion of patients who develop hypercalcuria
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2004
End Date
November 2004
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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 medical conditions that are not adequately treated

Outcomes

Primary Outcomes

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

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