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Clinical Trials/NCT00092066
NCT00092066
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

Organon and Co0 sites717 target enrollmentSeptember 24, 2003
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ConditionsOsteoporosisVitamin D Deficiency
DrugsMK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 weeks

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Osteoporosis
Sponsor
Organon and Co
Enrollment
717
Primary Endpoint
Proportion of patients with Vitamin D insufficiency (defined as serum 25-hydroxyvitamin levels <15 ng/mL) after 15 weeks of treatment.
Status
Completed
Last Updated
last year
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 the treatment of osteoporosis in men and postmenopausal women.

Registry
clinicaltrials.gov
Start Date
September 24, 2003
End Date
May 1, 2004
Last Updated
last year
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 significant medical conditions that are not adequately treated

Outcomes

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.

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