At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 308 enrolled
Drug / intervention
Ibandronatedrug
Likely dose
Ibandronate 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Open-Label, Multicenter Study to Evaluate the Change in Bone Turnover Markers After Once Monthly Oral Ibandronate Therapy in Treatment Naive Postmenopausal Osteoporosis Patients
In Brief
A Phase 4 clinical trial evaluating Ibandronate for Post Menopausal Osteoporosis. Completed, enrolled 308 participants across 53 sites in 2 countries.
Detailed Summary
This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Menopausal Osteoporosis
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2004
Primary CompletionMay 2006
First PostedNov 2015
TodayJul 2026
First PostedNov 6, 2015
Enrollment StartAug 1, 2004
Primary CompletionMay 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.7 years ago
Interventions
Ibandronatedrug
Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.