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:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT00325468
Eligibility Criteria:
Inclusion Criteria:
* Subject must be ambulatory
* Subject must have atteneded the 20010223 end-of-study visit and have completed all tests and procedures during the end-of-study visit
* signed informed consent must be obtained before any study-specific procedures
Exclusion Criteria:
* Experienced severe and/or serious adverse event which were thought to be related to denosumab administration during the 20010223 study.
* Developed grade 3 or 4 laboratory abnormalities based on Common Terminology Criteria for Adverse Events v3.0 during the 20010223 study which did not normalized upon follow up or did not have diagnosis or treatment.
* Newly diagnosed conditions such as hyper/hypo thyroidism, rheumatoid arthritis, other bone diseases, renal disease.
* Using therapies while participating in the 20010223 study such as oral bisphosphonates, calcitonin, oral strontium, SERMS, systemic glucocortiocosteriods.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00325468
Study Brief:
Protocol Section:
NCT00325468