Using Zoledronate to Prevent Bone Loss After Denosumab in Postmenopausal Women
Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2 (ZOLARMAB2)
This study is testing if giving zoledronate to postmenopausal women after stopping denosumab can help prevent bone loss and keep their bones healthy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 40 Years to 100 Years |
| Sex | Female |
| Sponsor | Aarhus University Hospital Academic / other |
| Drugs / interventions | denosumab |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT05655013 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of multiple infusions of zoledronate in postmenopausal women who have previously been treated with denosumab for osteoporosis. It aims to determine if zoledronate can prevent rebound bone turnover and subsequent bone loss after discontinuation of denosumab. The study is divided into two parts: the first part involves a randomized open-label design with 200 participants, while the second part is a double-blind study assessing the long-term effects of yearly zoledronate infusions. Participants will be monitored for changes in bone mineral density using DXA scans at various intervals.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 40 and older who have been treated with denosumab for at least two years.
Not a fit: Patients with recent low-energy fractures or severe osteoporosis (BMD T-score < -2.5) may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of bone loss and fractures in postmenopausal women after stopping denosumab.
How similar studies have performed: While the specific approach of this study is novel, previous studies have shown that bisphosphonates like zoledronate can be effective in managing osteoporosis.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aarhus
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Principal investigator: Bente Langdahl, MD, Professor, DMSc, PhD — Aarhus University Hospital
- Study coordinator: Anne Sophie Søllling, MD, PhD
- Email: annesoel@rm.dk
- Phone: 78 45 00 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.