Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT05405894
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT05405894
Study Brief:
Protocol Section:
NCT05405894