NCT06059222 The Optimised Use of Romozosumab Study
| NCT ID | NCT06059222 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Aarhus |
| Condition | Osteoporosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2023-10-02 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 270 participants in total. It began in 2023-10-02 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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: * 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) * 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
Contact & Investigator
Bente Langdahl, MD, Professor, DMSc, PhD,
STUDY DIRECTOR
Department of Endocrinology and Internal medicin, Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT06059222 clinical trial?
This trial is open to female participants only, aged 50 Years or older, studying Osteoporosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06059222 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06059222 currently recruiting?
Yes, NCT06059222 is actively recruiting participants. Contact the research team at vivmaa@rm.dk for enrollment information.
Where is the NCT06059222 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT06059222 clinical trial?
NCT06059222 is sponsored by University of Aarhus. The principal investigator is Bente Langdahl, MD, Professor, DMSc, PhD, at Department of Endocrinology and Internal medicin, Aarhus University Hospital. The trial plans to enroll 270 participants.