At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 436 enrolled
Drug / intervention
Romozosumab +1 moredrug
Likely dose
Not stated in 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.
An Open-label, Randomized, Teriparatide-controlled Study to Evaluate the Effect of Treatment With Romosozumab in Postmenopausal Women With Osteoporosis Previously Treated With Bisphosphonate Therapy
In Brief
A Phase 3 clinical trial evaluating Romozosumab and Teriparatide for Postmenopausal Osteoporosis. Completed, enrolled 436 participants across 50 sites in 11 countries.
Detailed Summary
The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
CountriesArgentina, Belgium, Canada, Colombia, Czechia, Denmark, Hungary, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2013
First PostedFeb 2013
Primary CompletionMay 2015
TodayJul 2026
First PostedFeb 21, 2013
Enrollment StartJan 31, 2013
Primary CompletionMay 14, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.4 years ago
Interventions
Romozosumabdrug
Administered by subcutaneous injection once a month.
Teriparatidedrug
Administered by subcutaneous injection once a day.