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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT00108394
Eligibility Criteria:
Inclusion Criteria:
* Dialysis dependent for a minimum of 3 months
* Age greater than 18 years
* Low or normal bone turnover as defined by a mean intact PTH ≤400 pg/ml from a minimum of two values 6 months apart
* Informed consent
Exclusion Criteria:
* Mean serum aluminum levels \> 20 mcg/L during 1 year prior to consent
* Documented dementia
* Comorbidity such that survival for \>3 years is unlikely
* Use of steroids within 3 months of consent
* Use of bisphosphonates in previous 2 years
* Use of sex hormones (testosterone or estrogen) within 3 months of consent
* Mean calcium \< 9.0 mg/dL during the two months prior to consent
* Peritoneal dialysis patients
* Body weight \< 45 kg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00108394
Study Brief:
Protocol Section:
NCT00108394