The OPTIMIST study
Phase 1
Recruiting
- Conditions
- osteoporosisTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- CTIS2023-505940-20-00
- Lead Sponsor
- Region Midtjylland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 270
Inclusion Criteria
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
Exclusion Criteria
Osteoporosis treatment within the last 5 years, Metabolic bone disease, Known disorders affecting bone metabolism, Ongoing treatment with glucocorticoids, Estimated glomerular filtration rate (eGFR) < 35 ml/min, Contraindications or intolerance to romosozumab or zoledronate
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: to investigate if romosozumab affects insulin sensitivity;Primary end point(s): Change in total hip BMD at 24 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Change in lumbar spine and femoral neck BMD at 24 months;Secondary end point(s):Change in HRpQCT derived bone microarchitecture at 24 months;Secondary end point(s):Changes in bone turnover markers during the course of the trial;Secondary end point(s):Bone modelling and remodelling assessed by histomorphometry of bone biopsies;Secondary end point(s):Increase in number and composition of osteoprogenitor cells in the bone marrow;Secondary end point(s):Effect of romosozumab on glucose metabolism and interaction with changes in bone turnover markers and BMD