Treatment with zoledronate subsequent to denosumab in osteoporosis 2
Key facts
- Where
- Aalborg és Aarhus N, DániaSee the 2 sites
- Phase
- 4. fázis
Where in Dánia
- Aalborg University HospitalAalborg, DániaTaking people
- Aarhus University HospitalAarhus N, DániaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aarhus University Hospital
- Trial code
- EU 2022-502621-17-00
- Record updated
- 2026. július 1.
- Original description
The aims of ZOLARMAB2 are fourfold. First, we want to investigate if multiple infusions of zoledronate can prevent the rebound activation of bone turnover and the subsequent bone loss in patients previously treated with denosumab and if there is difference between infusing zoledronate at fixed time-points after the last injection of denosumab or when bone turnover is increased. Second, we want to investigate if bone loss will resume after controlling the rebound activation of bone turnover during the first year after denosumab discontinuation and if this can be prevented by yearly infusions of zoledronate. Third, we want to investigate the underlying pathophysiological mechanisms by investigating biochemical markers, oste-oclast and osteoblast activation signals in the bone and bone marrow, and the pool of preosteoclasts/mature osteoclasts before and after treatment with zoledronate. Fourth, we want to investigate the effect of denosumab discontinuation on muscle mass and muscle strength and on insulin sensitivity.Read full original descriptionShow less
The aims of ZOLARMAB2 are fourfold. First, we want to investigate if multiple infusions of zoledronate can prevent the rebound activation of bone turnover and the subsequent bone loss in patients previously treated with denosumab and if there is difference between infusing zoledronate at fixed time-points after the last injection of denosumab or when bone turnover is increased. Second, we want to investigate if bone loss will resume after controlling the rebound activation of bone turnover during the first year after denosumab discontinuation and if this can be prevented by yearly infusions of zoledronate. Third, we want to investigate the underlying pathophysiological mechanisms by investigating biochemical markers, oste-oclast and osteoblast activation signals in the bone and bone marrow, and the pool of preosteoclasts/mature osteoclasts before and after treatment with zoledronate. Fourth, we want to investigate the effect of denosumab discontinuation on muscle mass and muscle strength and on insulin sensitivity.
Inclusion: 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: Treatment with other bisphosphonates (risedronate, ibandronate) for more than three years prior to denosumab treatment within the last five years; Ongoing treatment with systemic glucocorticoids; Hormone replacement therapy; 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; Diabetes Mellitus; Metabolic bone disease (for example osteogenesis imperfecta, Paget's disease of bone); Active cancer within the last 5 years with the exception of basal cell skin cancer; Estimated glomerular filtration rate (eGFR) ≤ 35 mL/min; Low-energy vertebral fracture within the last ten years; Contraindications for zoledronate according to the SPC; Unable to read and understand Danish; Immobility; 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).