Tests romosozumab and zoledronate timing in people with osteoporosis
Compares different schedules of two bone drugs in adults with osteoporosis, aged 50 or older.
Plain-language title generated from the registry record
Registry title: The Optimised Use of Romozosumab Study
Key facts
- Where
- Aarhus, DenmarkSee the site
- Phase
- Phase 4
Where in Denmark
- Department of Endrocinology and Internal MedicineAarhus, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Aarhus
- Trial code
- NCT06059222
- Record updated
- 2 July 2026
- Original description
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).Read full original descriptionShow less
The Optimised Use of Romozosumab Study
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.
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; Ongoing treatment with glucocorticoids (systemic); 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; 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.