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 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT00774020
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of PDB by radiological reports
* Serum Alkaline Phosphatase level (SAP) at least two times the upper limit of the normal (ULN)
Exclusion Criteria:
* History of hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates;
* History of malignancy of any organ system
* Severe liver or bladder disease;
* Calculated creatinine clearance \< 35 mL/min at baseline;
* Hypocalcaemia;
* Patients with pre-existing dental diseases or who predict to have dental surgeries during the study;
* Evidence of vitamin D deficiency.
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT00774020
Study Brief:
Protocol Section:
NCT00774020