Bone Histomorphometry Assessment For Incident Dialysis Patients withSecondary Hyperparathyroidism of End Stage Renal Disease - BONAFIDE

Amgen Inc.0 个研究点目标入组 85 人开始时间: 2006年1月30日最近更新: 2012年4月18日

适应症

试验速览

暂无简介。

•Subjects will be eligible for the study if they meet all of the following criteria:
•Men or women = 18 years of age at screening.
•Agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study.
•One biPTH determination obtained from the central laboratory must be = 160 pg/mL (17.0 pmol/L).
•One serum calcium determination obtained from the central laboratory must be =8.4 mg/dL (2.1 mmol/L).
•One BALP determination obtained from the central laboratory must be > 20.9 ng/mL.
•Positive histologic confirmation of high bone turnover disease. Positive confirmation is defined as any of the following:
•Osteoid area < 12%, BFR > 613 µm2/mm2/day, and no evidence of fibrosis
•Osteoid area < 12%, BFR > 97 µm2/mm2/day, and evidence of fibrosis
•Osteoid area > 12%, BFR > 97 µm2/mm2/day, with or without evidence of fibrosis
•Treated with dialysis for = 1 month and = 6 months before the date of informed consent.
•Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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.
•Received within 30 days before day 1, therapy FORTEOTM.
•Ever received therapy with Sensipar®/Mimpara®
•Ever received therapy with bisphosphonates
•- Other investigational procedures are excluded.
•- Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
•- Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study.
•- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.

发起方

Amgen Inc.