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

• Conditions: Secondary hyperparathyroidism (HPT) in subjects withCKD receiving dialysis.; MedDRA version: 14.1Level: SOCClassification code 10038359Term: Renal and urinary disordersSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2005-004643-53-IT
• Lead Sponsor: AMGEN S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-23
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 85

Inclusion 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 (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

Exclusion Criteria

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
General

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified