The Optimised Use of Romozosumab Study - Trial NCT06059222
Access comprehensive clinical trial information for NCT06059222 through Pure Global AI's free database. This Phase 4 trial is sponsored by University of Aarhus and is currently Recruiting. The study focuses on Osteoporosis. Target enrollment is 270 participants.
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Study Focus
Sponsor & Location
University of Aarhus
Timeline & Enrollment
Phase 4
Oct 02, 2023
Aug 01, 2026
Primary Outcome
Change in total hip BMD
Summary
OPTIMIST is a two-year, randomised, active controlled, open-label, multicentre intervention
 trial. OPTIMIST includes 3 treatment groups each comprising combinations of romosozumab
 (ROMO) and zoledronate (ZOL) treatment used in standard doses (210 mg monthly (sc) and 5 mg
 yearly (iv), respectively).
 
 The study will investigate if it is possible to maximize the effect of romosozumab by giving
 it in 2 periods of 6 months interrupted by zoledronate for 12 months compared to romosozumab
 for 12 months uninterrupted followed by zoledronate for 12 months. The investigators will
 also evaluate if 6 months of romosozumab followed by 18 months of zoledronate is non-inferior
 to the standard regimen of romosozumab for 12 months followed by zoledronate for 12 months.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06059222
Non-Device Trial