Optimizing osteoporosis treatment with romosozumab and zoledronate

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The OPTIMIST trial is a two-year, randomized, active controlled, open-label intervention that aims to maximize the effects of romosozumab in treating osteoporosis. It involves 270 postmenopausal women who will be assigned to three different treatment regimens combining romosozumab and zoledronate. The study will compare the effectiveness of these regimens in increasing bone mineral density and reducing fracture risk. Participants will receive either uninterrupted romosozumab followed by zoledronate or a combination of both treatments in varying sequences.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Endrocinology and Internal Medicine
  Aarhus, Denmark Recruiting

Study contacts

• Study coordinator: Vivi Makinen, MD
• Email: vivmaa@rm.dk
• Phone: 78450000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.