Bone Histomorphometry Assessment For Incident Dialysis Patients with Secondary Hyperparathyroidism of End Stage Renal Disease(BONAFIDE STUDY) - (BONAFIDE STUDY)

AMGEN S.P.A.0 个研究点目标入组 85 人开始时间: 2006年6月23日最近更新: 2013年1月7日

研究概览

暂无简介。

•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
•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
•? 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
•Treated with dialysis for ≥ 1 month and ≤ 6 months before the date of informed
•Ethical - Before any study-specific procedure, the appropriate written informed
•consent must be obtained (see Section 13.1).
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•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

•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

发起方

AMGEN S.P.A.