Taking people in DenmarkPhase 4
Compares ways of using romosozumab to treat osteoporosis in adults
Tests different treatment strategies with romosozumab in adults with osteoporosis.
Key facts
- Who runs it
- Aarhus University Hospital
- Where
- Aalborg, Aarhus N, Copenhagen Nv, Hvidovre, and Odense C, DenmarkSee the 5 sites
- Trial code
- Registry title
- The OPTIMIST study
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 270 people, planned
- Started
- 26 Sept 2023
- Expected to end
- 31 Aug 2029
- Type of study
- Interventional
- Record updated
- 5 October 2026
Who can take part
AI summary
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 women after menopause who have osteoporosis and have already had a bone fracture. It compares 3 ways of using the drug romosozumab.
- Age
- 18 years or older
- Sex
- Women only (postmenopausal)
- Disease stage
- Osteoporosis with a BMD T-score below -2.5 at the spine, total hip or femoral neck, and an osteoporotic fracture of the spine, hip, pelvis, forearm or humerus within 3 years after the age of 50
- Earlier treatment
- No osteoporosis treatment within the last 5 years
Main reasons for not taking part
- Osteoporosis treatment within the last 5 years
- Metabolic bone disease or other known disorders affecting bone metabolism
- Ongoing treatment with glucocorticoids
- eGFR below 35 ml/min
- Contraindication or intolerance to romosozumab or zoledronate
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- postmenopausal women
- Osteoporosis defined as BMD T-score < -2.5 at spine, total hip or femoral neck
- Osteoporotic fracture at spine, hip, pelvis, forearm, or humerus within 3 years after the age of 50 years
Who cannot take part
- Ongoing treatment with glucocorticoids
- Metabolic bone disease
- Known disorders affecting bone metabolism
- Estimated glomerular filtration rate (eGFR) < 35 ml/min
- Osteoporosis treatment within the last 5 years
- Contraindications or intolerance to romosozumab or zoledronate
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkTaking people
- Aarhus UniversitetshospitalAarhus N, DenmarkTaking people
- Bispebjerg HospitalCopenhagen Nv, DenmarkTaking people
- Hvidovre HospitalHvidovre, DenmarkTaking people
- Odense University HospitalOdense C, DenmarkTaking people
About the trial
What the trial wants to find out
The main objective of the OPTIMIST study is to identify the optimal use of romosozumab for the treatment of osteoporosis by investigating 3 different treatment strategies.
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
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- The Optimised use of Romosozumab Study
- Plain-language title
- Compares ways of using romosozumab to treat osteoporosis in adultsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 5 October 2026