The Optimised Use of Romozosumab Study
Recruiting
Phase 4
Interventional Study
Osteoporosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 50 and older
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 270 (estimated)
- Sponsor
- University of Aarhus · Other
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About This Trial
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 …
Trial Locations
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Eligibility 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:
* Osteo…
Contacts