Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2
Osteoporosis, Postmenopausal
About this trial
This is an interventional treatment trial for Osteoporosis, Postmenopausal
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Low-energy vertebral fracture at any time Low-energy hip fracture within the last 12 months BMD T-score < -2.0 (lumbar spine, total hip or femoral neck) Bisphosphonate treatment for more than three years prior to denosumab treatment Diabetes Mellitus Ongoing treatment with systemic glucocorticoids 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 Estimated glomerular filtration rate (eGFR) ≤ 35 mL/min Contraindications for zoledronate according to the SPC Unable to read and understand Danish
Sites / Locations
- Aarhus University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
First part (year 1): groups 1+2
First part (year 1): groups 3+4
Second part (year 2-3): groups 1+3
Second part (year 2-3): groups 2+4
Zoledronate will be administered as an infusion six months after the last injection of denosumab followed by zoledronate infusions 3 and 6 months thereafter
Zoledronate will be administered as an infusion six months after the last injection of denosumab followed by zoledronate infusions when bone turnover is increased (s-carboxy-terminal collagen crosslinks (p-CTX) > 0.4 ug/l which corresponds to the upper 50 % of the normal range for premenopausal women).
Patients will receive yearly infusions of zoledronate 5 mg
Patients will receive yearly infusions of placebo.