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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT02721433
Eligibility Criteria:
Inclusion Criteria:
* Patients with either radiologically and/or histologically confirmed bone metastases from castrate resistant prostate cancer (36) or breast cancer.
* About to start or currently receiving BTA therapy.
* Serum creatinine \>30 ml/min and corrected serum calcium ≥ 2 mmol/l
* Age ≥ 18 years.
* Able to provide verbal consent
Exclusion Criteria:
* For CRPC patients - Definite contraindication for denosumab at baseline (e.g. hypocalcaemia \[Albumin-corrected serum calcium \< 2.0 mmol/l\]).
* History of or current evidence of osteonecrosis of the jaw.
* Radiotherapy or surgery to the bone planned within 4 weeks after randomization.
* Known hypersensitivity to trial drug or hypersensitivity to any other component of the trial drug (e.g. fructose).
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02721433
Study Brief:
Protocol Section:
NCT02721433