NCT05655013Active, not recruitingPhase 4
Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2 (ZOLARMAB2)
Source: ClinicalTrials.gov · Last updated 2 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 29 Nov 2022
- Start date
- 10 May 2023
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Aarhus University Hospital
- Diseases
- Osteoporosis
- NCT number
- NCT05655013
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- From 10 May 2023 to the primary completion date, 1 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Ongoing treatment with systemic glucocorticoids
- Hormone replacement therapy
Other illness
- 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
Lab values
- Estimated glomerular filtration rate (eGFR) ≤ 35 mL/min
Other
- 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)
- Contraindications for zoledronate according to the SPC
- Unable to read and understand Danish
- Immobility
Who the study is looking for
- 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
Age in the registry: 40 years to 100 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.