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Study Complete
Sponsor ID
20050104

Bone Biopsy Study For Dialysis Patients with Secondary Hyperparathyroidism of End Stage Renal DiseaseBONAFIDE

Sponsor ID
20050104
Clinicaltrials.gov ID
NCT00261950
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to evaluate the effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.

Additional Study Details

Phase
Phase 2
Product
cinacalcet hcl
Type
Interventional
Masking
None (Open Label)
Enrollment
110
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change from baseline in bone turnover parameters

Timeframe: 52 weeks

Secondary Outcome Measures

Changes in bone turnover parameters at one year; safety and tolerability of cinacalcet at one year.

Timeframe: 52 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Flushing, NY, United States, 11355
Status
Completed
Location
Research Site
St Louis, MO, United States, 63110
Status
Completed
Location
Research Site
Los Angeles, CA, United States, 90095
Status
Completed
Location
Research Site
New Orleans, LA, United States, 70121
Status
Completed
Location
Research Site
Allentown, PA, United States, 18103
Status
Completed
Location
Research Site
Denver, CO, United States, 80220
Status
Completed
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Study Info
Age
18+ years
Condition
  • Hyperparathyroidism
    • Sex
    All
    Trial Dates
    May 2006 - May 2011
    Inclusion and Exclusion 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®