Efficacy of a Single Infusion of Zoledronic Acid to Mitigate the Rebound Effect of Rapid Bone Loss Following Denosumab Treatment Discontinuation

REB21-1898

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.

2022-09-01

2024-07-01

2025-07-01

Active (not recruiting)

20

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

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2024-05-14