The Optimised Use of Romozosumab Study

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• Change in total hip BMD — 24 months
  Change in total hip BMD

Trial sites (1)

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