Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2 (ZOLARMAB2) (NCT05655013) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2 (ZOLARMAB2)
Denmark200 participantsStarted 2023-05-10
Plain-language summary
The aims of ZOLARMAB2 are fourfold. First, the investigators 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, the investigators 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, the investigators want to investigate the underlying pathophysiological mechanisms by investigating biochemical markers, osteoclast and osteoblast activation signals in the bone and bone marrow, and the pool of preosteoclasts/mature osteoclasts before and after treatment with zoledronate.
Fourth, the investigators want to investigate the effect of denosumab discontinuation on muscle mass and muscle strength and on insulin sensitivity.
Who can participate
Age range
40 Years – 100 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 six months ago
* At least 2 lumbar vertebrae that can be evaluated by DXA
Exclusion Criteria:
* Low-energy vertebral fracture within the last ten years
* Multiple low-energy vertebral fractures (\> 3) at any time
* Low-energy hip fracture within the last 12 months
* BMD T-score \< -2.5 (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 10 the 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
* 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
* Immobility
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in lumbar spine bone mineral density (BMD)
Timeframe: After 12 and 36 months.
2
The proportion of patients who fails to maintain bone mineral density (BMD)