None listed
Conditions
Brief summary
ZEAL is a single-centre, open-label, 1:1 randomised controlled trial at Westmead Hospital enrolling adults with osteoporosis who are stopping denosumab after greater than or equal to 2.5 to less than or equal to 6 years of therapy. It compares early zoledronic acid 5 mg IV at 3 months after the last denosumab dose (second dose 6 months later) versus on-time zoledronic acid at 6 months (second dose 6 months later). The primary endpoint is change in lumbar spine and total hip BMD from baseline to 18 months after the last denosumab dose. Secondary outcomes include bone turnover markers, proportion with >5% BMD loss, incident vertebral and non-vertebral fractures, and safety, with biomarker-guided rescue dosing permitted. Thirty-six participants will be followed for up to 24 months with 3-monthly assessments.
Interventions
Zoledronic acid 5 mg Intravenous infusion over ~30 minutes (100 mL solution) by a research nurse.
First dose 3 months after the participant’s last denosumab injection; second dose 9 months after the last denosumab injection (i.e., 6 months after the first dose). Additional doses may be given per protocol-defined triggers including elevated bone resorption as measured by serum CTX and/or loss in bone mineral density.
Adherence to the intervention will be assessed and recorded on the participant's
Zoledronic acid 5 mg Intravenous infusion over ~30 minutes (100 mL solution) by a research nurse. First dose 3 months after the participant’s last denosumab injection; second dose 9 months after the last denosumab injection (i.e., 6 months after the first dose). Additional doses may be given per protocol-defined triggers including elevated bone resorption as measured by serum CTX and/or loss in bone mineral density. Adherence to the intervention will be assessed and recorded on the participant's medical record and study visit log.
Sponsors
Western Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged above 50 years of age Received denosumab for 2.5-6 years for the management of osteoporosis BMD T-score at the lumbar spine and total hip greater than -2.5 SD Planned to discontinue denosumab therapy
Exclusion criteria
Baseline BMD T-score measured by DXA at the lumbar spine or total hip less than -2.5SD Previous allergic reaction to denosumab or zoledronic acid Known renal impairment (creatinine clearance 20% loss of height Unable to give informed consent – including dementia or other cognitive impairment
Outcome results
None listed