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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT00261950
Eligibility Criteria:
Inclusion Criteria: Subjects will be eligible for the study if they meet all of the following criteria:
* One Intact Parathyroid Hormone (iPTH) determination obtained from the central laboratory must be \>/= 300 pg/mL.
* One serum calcium determination obtained from the central laboratory must be \>/= 8.4 mg/dL (2.1 mmol/L).
* One Bone Alkaline Phosphatase (BALP) determination obtained from the central laboratory must be \>/= 20.9 ng/mL.
* Positive histologic confirmation of high bone turnover disease as assessed by the central bone histology center.
* Treated with dialysis \>/= 1 month before the date of informed consent.
Exclusion Criteria: Subjects will be ineligible for the study if they:
* Have an unstable medical condition in the judgment of the investigator.
* Are pregnant or nursing women.
* Had a parathyroidectomy in the 3 months before the date of informed consent.
* For subjects prescribed vitamin D, have received vitamin D therapy for less than 30 days before day 1 or required a change in vitamin D brand or dose level within 30 days before day 1.
* Ever received therapy with Sensipar®/Mimpara®
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00261950
Study Brief:
Protocol Section:
NCT00261950