ALEXIS
Phase 1
- Conditions
- osteoporosisTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- CTIS2023-510042-24-01
- Lead Sponsor
- Odense University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1400
Inclusion Criteria
Female, Postmenopausal, Current treatment with Alendronate, Alendronate treatment >3 år AND no fracture OR Alendronate treatment >5 år AND latest low energy fracture > 3 years ago
Exclusion Criteria
T-score < - 3,5 in hip (total hip or femoral neck) or lumbar spine, Treatment with systemic glucocorticoids, ongoing or within 12 months, Uncontrolled inflammatory disease, Active malignancy, eGFR < 40 mL/min, Atypical femur fracture (ever), OsteoNecrosis of the Jaw (active), Unable to give inform consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method