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
Inclusion Criteria3
- 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 Criteria9
- 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
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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