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Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)

NCT00729651 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2024-04-23

Study results available
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Summary

To demonstrate the efficacy/safety of Fosamax Plus D

Conditions

  • Osteoporosis Postmenopausal

Interventions

DRUG

alendronate sodium (+) cholecalciferol

Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks

DRUG

Comparator: Alendronate sodium (Fosamax)

Alendronate sodium; tablet, once weekly, for 16 weeks

DIETARY_SUPPLEMENT

Comparator: Calcium

500 mg oral tablet calcium once daily, for 16 weeks

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-20
Primary Completion
2009-04-10
Completion
2009-04-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00729651 on ClinicalTrials.gov