The Optimised Use of Romozosumab Study

• Status: Recruiting
• Trial end date: 2026-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Treatments: Antibodies, Monoclonal; Zoledronic Acid

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Osteoporosis treatment including hormone replacement therapy within the last 5 years

• Metabolic bone disease

• Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, liver dysfunction (baseline phosphatase higher than twice upper limit), rheumatism, severe COPD (chronic obstructive pulmonary disease), hypopituitarism, Cushing's disease

• Ongoing treatment with glucocorticoids (systemic)

• Estimated glomerular filtration rate (eGFR) < 35 mL/min

• Contraindications for zoledronate according to the Supplementary protection certificates (SPC)

• Contraindications for romosozumab according to the SPC

• For the subgroup with Jamshidi biopsies contraindications for local anaesthetics according to the SPC

• For the subgroup with Jamshidi biopsies contraindications for tetracycline or doxycykline according to the SPC