Treatment with zoledronate subsequent to denosumab in osteoporosis 2
- Conditions
- OsteoporosisTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- CTIS2022-502621-17-00
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1
Postmenopausal women (postmenopausal for at least two years), Age = 40 years, Treatment for at least two years with denosumab, Last denosumab injection less than five months ago, At least 2 lumbar vertebrae that can be evaluated by DXA
Low-energy vertebral fracture within the last ten years, Treatment with other bisphosphonates (risedronate, ibandronate) for more than three years prior to denosumab treatment within the last five years, Diabetes Mellitus, Ongoing treatment with systemic glucocorticoids, Estimated glomerular filtration rate (eGFR) = 35 mL/min, Contraindications for zoledronate according to the SPC, Unable to read and understand Danish, Immobility, Metabolic bone disease (for example osteogenesis imperfecta, Paget's disease of bone), Hormone replacement therapy, Active cancer within the last 5 years with the exception of basal cell skin cancer, Multiple low-energy vertebral fractures (>= 3) at any time, Low-energy hip fracture within the last 12 months, BMD T-score < -2.0 (lumbar spine, total hip or femoral neck), Zoledronate treatment for more than three years prior to denosumab treatment within the last ten years, Alendronate treatment for more than three years prior to denosumab treatment within the last five years or for more than five years within the last the years
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