New study tests drug combo to keep bones strong after osteoporosis treatment ends
NCT ID NCT05655013
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving zoledronate infusions can prevent bone loss in postmenopausal women who have stopped taking denosumab for osteoporosis. About 200 women who took denosumab for at least two years will receive zoledronate at different times. The goal is to find the best way to maintain bone density and prevent fractures.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 100 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aarhus University Hospital
Aarhus, Denmark
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Other studies related to the condition(s) this trial covers.
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