Status:
RECRUITING
The Optimised Use of Romozosumab Study
Lead Sponsor:
University of Aarhus
Conditions:
Osteoporosis
Eligibility:
FEMALE
50+ years
Phase:
PHASE4
Brief 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 zoledrona...
Detailed Description
Recent clinical trials have demonstrated the benefit of bone anabolic treatment over no treatment or antiresorptive treatment in terms of increasing bone mineral density (BMD) and reducing fracture ri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT06059222
Start Date
October 2 2023
End Date
August 1 2026
Last Update
October 25 2023
Active Locations (1)
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1
Department of Endrocinology and Internal Medicine
Aarhus, Denmark, 8000