The Optimised Use of Romozosumab Study
University of Aarhus
270 participants
Oct 2, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Romosozumab 210 mg/2.34 ml from baseline to month 11
5 mg/100 ml at month 12
210 mg/2.34 ml from baseline to month 5 and from month 18 to month 23
5 mg/100 ml at month 6
210 mg/2.34 ml from baseline to month 5
5 mg/100 ml at month 5 and month 18
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06059222