Actively Recruiting
The Optimised Use of Romozosumab Study
Led by University of Aarhus · Updated on 2023-10-25
270
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Optimised Use of Romozosumab Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenopausal women (postmenopausal for at least two years)
- Bone mineral density T-score less than -2.5 at lumbar spine, total hip, or femoral neck
- Osteoporotic fracture within the last 3 years at spine, hip, pelvis, humerus, or forearm after age 50
You will not qualify if you...
- Osteoporosis treatment including hormone replacement therapy within the last 5 years
- Metabolic bone disease
- Known disorders affecting bone metabolism such as uncontrolled thyrotoxicosis, liver dysfunction with phosphatase higher than twice upper limit, rheumatism, severe COPD, hypopituitarism, Cushing's disease
- Ongoing systemic glucocorticoid treatment
- Estimated glomerular filtration rate (eGFR) less than 35 mL/min
- Contraindications for zoledronate according to Supplementary Protection Certificates (SPC)
- Contraindications for romosozumab according to SPC
- For the subgroup with Jamshidi biopsies, contraindications for local anaesthetics, tetracycline, or doxycycline according to SPC
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Endrocinology and Internal Medicine
Aarhus, Denmark, 8000
Actively Recruiting
Research Team
V
Vivi Makinen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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