NCT06059222RecruitingPhase 4
The Optimised Use of Romozosumab Study
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- First submitted
- 8 Sept 2023
- Start date
- 2 Oct 2023
- Primary completion date
- 31 Aug 2030
- Lead sponsor
- University of Aarhus
- Diseases
- Osteoporosis
- NCT number
- NCT06059222
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 270
- From 2 Oct 2023 to the primary completion date, 31 Aug 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Osteoporosis treatment including hormone replacement therapy within the last 5 years
- Ongoing treatment with glucocorticoids (systemic)
Other illness
- 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
Lab values
- Estimated glomerular filtration rate (eGFR) \< 35 mL/min
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Endrocinology and Internal Medicine Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.