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Treatment with zoledronate subsequent to denosumab in osteoporosis 2
EU CTIS ID: 2022-502621-17-00
What this study is testing
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.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.