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Study of Investigational Drug in Osteoporosis (MK-0217-908)

NCT00092053 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2022-02-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of an investigational drug in postmenopausal women with osteoporosis. The primary hypothesis of this study is that in postmenopausal women with osteoporosis, oral monthly ibandronate, at doses of 100 mg and 150 mg, does not achieve persistence in reduction of bone resorption throughout the monthly dosing interval, as demonstrated by a larger change in the serum carboxyterminal crosslinked telopeptide of Type I collagen (CTX-I) log-transformed fraction from baseline four weeks post dose compared to one week post dose, during the third month of treatment, in the participants taking ibandronate than in the participants taking placebo.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

Placebo

tablets

DRUG

ibandronate

50 mg tablets

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2005-07-31
Completion
2005-07-31

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Drugs

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 NCT00092053 on ClinicalTrials.gov