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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for postmenopausal women with osteoporosis who have had a bone fracture after age 50. It compares ways of giving romosozumab and zoledronate.
- Age
- From 50 years
- Sex
- Women only
- Disease stage
- Osteoporosis with a BMD T-score below -2.5 at the lumbar spine, total hip or femoral neck, and an osteoporotic fracture within the last 3 years at the spine, hip, pelvis, humerus or forearm after age 50.
- Earlier treatment
- Must not have had osteoporosis treatment, including hormone replacement therapy, within the last 5 years.
- Biomarker or test result
- BMD T-score below -2.5 (bone density scan).
Main reasons for not taking part
- Osteoporosis treatment, including hormone replacement therapy, within the last 5 years
- Metabolic bone disease or other known disorders affecting bone metabolism
- Ongoing treatment with systemic glucocorticoids
- Estimated glomerular filtration rate (eGFR) below 35 mL/min
- Contraindications for zoledronate or romosozumab
Read by machine on 12 November 2026.
Where in Denmark
- Department of Endrocinology and Internal MedicineAarhus, DenmarkContact: Vivi MäkinenTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.