CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 716 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.

Search/NCT00545363
NCT00545363Phase 4Completed
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A Randomized Open-Label Study to Investigate the Impact of Bone Marker Feedback at 3 Months on Adherence to Monthly Oral Bonviva in Women With Post-Menopausal Osteoporosis Supported by a Patient Relationship Program

Hoffmann-La Roche·interventional·Posted Oct 17, 2007·Updated Oct 24, 2016

In Brief

A Phase 4 clinical trial evaluating Ibandronate for Postmenopausal Osteoporosis. Completed, enrolled 716 participants across 52 sites in 7 countries.

Detailed Summary

This 2 arm study will assess the impact of bone marker feedback (BMF), using serum carboxy-terminal collagen crosslinks (CTX) and communication of results at 3 months, on adherence to once monthly ibandronate (150 milligrams \[mg\] per oral \[po\]) in women with post-menopausal osteoporosis supported by patient-relationship program (PRP). Participants will be randomized either to receive BMF or no BMF; both groups will be supported by PRP. The anticipated time on study treatment is 3-12 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
CountriesHungary, Latvia, Poland, Romania, Russia, Slovakia, Slovenia
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 17, 2007
Enrollment StartApr 1, 2006
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.7 years ago

Interventions

Ibandronatedrug

Participants will receive ibandronate 150 mg QM orally for 6 months.