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Clinical Trials in Denmark / NCT05655013
Active, not recruiting Phase 4

Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2 (ZOLARMAB2)

NCT05655013 · tracked via the Priya Life Science Denmark tracker
Sponsor
Aarhus University Hospital
Phase
Phase 4
Started
2023-05-10
Last updated
2025-10-02

Condition(s) studied

Osteoporosis, Postmenopausal

Investigational drug(s) / intervention(s)

Zoledronate →Placebo

Zoledronate: zoledronate 5 mg

Placebo: isotonic saline 100 mL

Study 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.

Eligibility

Sex
FEMALE
Min age
40 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in lumbar spine bone mineral density (BMD) — After 12 and 36 months.
    Change in lumbar spine BMD after 12 and 36 months.
  • The proportion of patients who fails to maintain bone mineral density (BMD) — After 12 months.
    The proportion of patients (%) with significant decrease in BMD (≥ 3 % BMD loss at the lumbar spine or ≥ 5 % BMD loss at the femoral neck or total hip) after 12 months.

Trial sites (1)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05655013 on ClinicalTrials.gov ↗ ← All trials in Denmark