Optimizing osteoporosis treatment with romosozumab and zoledronate
The Optimised Use of Romozosumab Study
This study is testing different ways to use two osteoporosis treatments, romosozumab and zoledronate, to see which combination helps postmenopausal women build stronger bones and lower their risk of fractures.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | University of Aarhus Academic / other |
| Drugs / interventions | romosozumab |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT06059222 on ClinicalTrials.gov |
What this trial studies
The OPTIMIST trial is a two-year, randomized, active controlled, open-label intervention that aims to maximize the effects of romosozumab in treating osteoporosis. It involves 270 postmenopausal women who will be assigned to three different treatment regimens combining romosozumab and zoledronate. The study will compare the effectiveness of these regimens in increasing bone mineral density and reducing fracture risk. Participants will receive either uninterrupted romosozumab followed by zoledronate or a combination of both treatments in varying sequences.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women with a BMD T-score of less than -2.5 and a history of osteoporotic fractures.
Not a fit: Patients currently receiving osteoporosis treatment or with certain metabolic bone diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for osteoporosis, enhancing bone density and reducing fracture risk in postmenopausal women.
How similar studies have performed: Previous studies have shown the benefits of romosozumab in osteoporosis treatment, but this specific combination approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aarhus
- Department of Endrocinology and Internal Medicine — Aarhus, Denmark (Recruiting)
Study contacts
- Study coordinator: Vivi Makinen, MD
- Email: vivmaa@rm.dk
- Phone: 78450000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.