The Optimised Use of Romozosumab Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 50
Healthy Volunteers: f
View:

• Postmenopausal women (postmenopausal for at least two years)

• BMD T-score \< -2.5 at lumbar spine, total hip, or femoral neck

• Osteoporotic fracture within the last 3 years at the spine, hip, pelvis, humerus or forearm after the age of 50 years.

Locations
Other Locations
Denmark
Department of Endrocinology and Internal Medicine
RECRUITING
Aarhus
Contact Information
Primary
Vivi Makinen, MD
vivmaa@rm.dk
78450000
Time Frame
Start Date: 2023-10-02
Estimated Completion Date: 2026-08
Participants
Target number of participants: 270
Treatments
Active_comparator: Group 1 - ROMO 12 months, ZOL 12 months
90 patients 12 months of romosozumab (ROMO) followed by 12 months of zoledronate (ZOL)
Active_comparator: Group 2 - ROMO 6 months, ZOL 12 months, ROMO 6 months
90 patients 6 months of romosozumab followed by 12 months of zoledronate and lastly 6 months of romosozumab.
Active_comparator: Group 3 - ROMO 6 months, ZOL 18 months
90 patients 6 months of romosozumab followed by 18 months of zoledronate~.
Related Therapeutic Areas
Sponsors
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov