2022-502621-17-00RecruitingPhase 4
Treatment with zoledronate subsequent to denosumab in osteoporosis 2
Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1 (estimated)
- First submitted
- 7 Dec 2022
- Start date
- 11 May 2023
- Lead sponsor
- Aarhus University Hospital
- Diseases
- Osteoporosis
- EU CT number
- 2022-502621-17-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for postmenopausal women who have taken denosumab for osteoporosis for at least two years and had their last injection less than five months ago.
- Age
- 40 years or older
- Sex
- Women only
- Disease stage
- Osteoporosis; postmenopausal for at least two years; at least 2 lumbar vertebrae that can be checked by a DXA bone scan
- Earlier treatment
- Must have had denosumab for at least two years, with the last injection less than five months ago. Long earlier use of some other bone drugs, or recent hormone replacement therapy, is not allowed.
Main reasons for not taking part
- Diabetes
- Low-energy vertebral fracture within the last ten years, or 3 or more at any time
- Low-energy hip fracture within the last 12 months
- Ongoing treatment with systemic glucocorticoids
- eGFR of 35 mL/min or less, or a contraindication for zoledronate
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
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
- 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)
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 five months ago
- At least 2 lumbar vertebrae that can be evaluated by DXA
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | Recruiting |
| Aarhus University Hospital | Aarhus N | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.