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The Optimised Use of Romozosumab Study
Sponsor: University of Aarhus
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.
Key Details
Gender
FEMALE
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
270
Start Date
2023-10-02
Completion Date
2026-08
Last Updated
2023-10-25
Healthy Volunteers
No
Conditions
Interventions
Romosozumab
Romosozumab 210 mg/2.34 ml from baseline to month 11
Zoledronate
5 mg/100 ml at month 12
Romosozumab
210 mg/2.34 ml from baseline to month 5 and from month 18 to month 23
Zoledronate
5 mg/100 ml at month 6
Romosozumab
210 mg/2.34 ml from baseline to month 5
Zoledronate
5 mg/100 ml at month 5 and month 18
Locations (1)
Department of Endrocinology and Internal Medicine
Aarhus, Denmark