drugset / Trial / NCT00092053

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

NCT00092053

Phase 3 Completed 203 enrolled Organon and Co
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibandronate Other / unclassified 100 mg Oral
Subject Ibandronate Other / unclassified 150 mg Oral