The Optimised Use of Romozosumab Study

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.

NCT Number	NCT06059222
Lead Sponsor	University of Aarhus
Conditions	Osteoporosis
Enrollment	270 participants
Start Date	2023-10-02
Primary Completion	2030-08-31 (estimated)
Study Completion	2032-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-02