Status:
UNKNOWN
Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
Lead Sponsor:
University of Calgary
Conditions:
Osteoporosis
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
Brief Summary
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 bo...
Detailed Description
As part of an observational study, twenty female osteoporosis patients looking to transition off denosumab therapy will be recruited from the David Hanley Osteoporosis Centre and affiliated primary ca...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05405894
Start Date
September 1 2022
End Date
July 1 2025
Last Update
May 14 2024
Active Locations (1)
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1
University of Calgary, McCaig Institute for Bone and Joint Health
Calgary, Alberta, Canada, T2N 4Z6