The Optimised Use of Romozosumab Study
ConditionOsteoporosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age50+
SponsorUniversity of Aarhus
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 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Osteoporosis treatment including hormone replacement therapy within the last 5 years
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
Ongoing treatment with glucocorticoids (systemic)
Trial design
Treatments tested in this trial
- Romosozumab
- Zoledronate
- Romosozumab
- Zoledronate
- Romosozumab
- Zoledronate
Treatment groups
270 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov