Osteoporosis Clinical Trial
Official title:
Efficacy of a Single Infusion of Zoledronic Acid to Mitigate the Rebound Effect of Rapid Bone Loss Following Denosumab Treatment Discontinuation
Verified date | November 2023 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This two-year observational, open-label clinical trial will evaluate the efficacy of a once-yearly infusion of zoledronic acid after denosumab discontinuation to maintain tissue mineral density and bone microarchitecture using high-resolution peripheral quantitative computed tomography (HR-pQCT) among post-menopausal women with osteoporosis.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | July 1, 2025 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Post-menopausal females with osteoporosis - Anticipating or preparing to transition off active denosumab treatment for osteoporosis with the use of a once-yearly infusion of zoledronic acid - Received at least 2 injections of denosumab treatment - Had a recent test (within 6 months) of serum creatine, calcium and phosphate Exclusion Criteria: - Any person for whom zoledronic acid would be considered contraindicated - Pre-menopausal females - Any person with significant chronic kidney disease (eGFR < 50 ml/m2 at time of osteoporosis clinical assessment) - Any person with previous adverse reactions or allergy to bisphosphonate therapies - Any person with non-corrected hypocalcaemia - Any person currently taking, and unable to discontinue the use of, prohibited medications including: ZOMETA, other bisphosphonate therapies, calcitonin, aminoglycosides, loop diuretics and agiogenesis inhibitors - Any person with other history, condition, therapy, or uncontrolled intercurrent illness, which could in the opinion of the Qualified Medical Investigator affect compliance with study requirements or which would make the participant unsuitable for this study - Any person with simultaneous participation in another interventional clinical study (e.g., Phase 1-3 clinical studies) or treatment with any investigational medicinal product within 30 days prior to screening visit |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary, McCaig Institute for Bone and Joint Health | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
Anastasilakis AD, Polyzos SA, Makras P, Aubry-Rozier B, Kaouri S, Lamy O. Clinical Features of 24 Patients With Rebound-Associated Vertebral Fractures After Denosumab Discontinuation: Systematic Review and Additional Cases. J Bone Miner Res. 2017 Jun;32(6):1291-1296. doi: 10.1002/jbmr.3110. Epub 2017 Mar 13. — View Citation
Solling AS, Harslof T, Langdahl B. Treatment with Zoledronate Subsequent to Denosumab in Osteoporosis: a Randomized Trial. J Bone Miner Res. 2020 Oct;35(10):1858-1870. doi: 10.1002/jbmr.4098. Epub 2020 Jul 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Optional further assessment of change in volumetric Bone Mineral Density (BMD)/bone microarchitecture from baseline | High-resolution peripheral computed tomography scan (radius and tibia) will be used to quantify volumetric BMD/bone microarchitecture | Change from Baseline to 24-months | |
Other | Optional further assessment of change in areal Bone Mineral Density (BMD) from baseline | Dual X-ray absorptiometry scan (lumbar spine, lateral vertebral assessment, and hip) will be used to quantify areal BMD | Change from Baseline to 24-months | |
Primary | Change in volumetric Bone Mineral Density (BMD)/bone microarchitecture from baseline | High-resolution peripheral computed tomography scan (radius and tibia) will be used to quantify volumetric BMD/bone microarchitecture | Change from Baseline (within 1-month of infusion) to 6-months and 12-months | |
Primary | Change in areal Bone Mineral Density (BMD) from baseline | Dual X-ray absorptiometry scan (lumbar spine, lateral vertebral assessment, and hip) will be used to quantify areal BMD | Change from Baseline (within 1-month of infusion) to 6-months and 12-months | |
Secondary | Fractures | Any clinically diagnosed fractures will be reported by treating physician | 1 year | |
Secondary | MoJo Fracture Risk Questionnaire | An assessment of fracture risk | 1 year |
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