Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00261950
First received: December 2, 2005
Last updated: October 7, 2013
Last verified: October 2013

December 2, 2005
October 7, 2013
January 2006
May 2011   (final data collection date for primary outcome measure)
Change From Baseline to End of Study in Bone Formation Rate (BFR) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Change from baseline in bone turnover parameters
Complete list of historical versions of study NCT00261950 on ClinicalTrials.gov Archive Site
  • Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in BALP at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Osteocalcin (OC) at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in NTx at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in TRAP at Week 52 [ Time Frame: 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in PTH During the Efficacy Assessment Phase (EAP) [ Time Frame: Baseline to weeks 40-52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP) [ Time Frame: Baseline to weeks 40-52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP) [ Time Frame: Baseline to weeks 40-52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP) [ Time Frame: Baseline to weeks 40-52 ] [ Designated as safety issue: No ]
Changes in bone turnover parameters at one year; safety and tolerability of cinacalcet at one year.
Not Provided
Not Provided
 
Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
Bone Histomorphometry Assessment For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease

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

Secondary HPT is common in people with end stage renal disease (kidney disease). Patients with secondary HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck. Patients with secondary HPT may have bone disease (osteodystrophy). This bone disease may cause bone pain, fractures, and poor formation of red blood cells. Other problems from secondary HPT may include increases in blood levels of calcium and phosphorus. These may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis, muscle inflammation, itching, gangrene, or heart and lung problems. The purpose of this study is to evaluate the effects of cinacalcet on bone function and bone cells in patients with kidney disease who are receiving dialysis. Cinacalcet has been used to decrease PTH levels in patients with secondary HPT.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Secondary Hyperparathyroidism
Drug: Sensipar (Cinacalcet HCl)
30 mg, 60mg, 90mg, 120mg, 180 mg taken once daily
Experimental: I
100% of subjects on study (85 subjects)
Intervention: Drug: Sensipar (Cinacalcet HCl)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria: Subjects will be eligible for the study if they meet all of the following criteria:

  • One 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 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®
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Czech Republic,   Hungary,   Italy,   Macedonia, The Former Yugoslav Republic of,   Poland,   Portugal,   Spain,   Switzerland,   Turkey,   United Kingdom
 
NCT00261950
20050104, BONAFIDE Study
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP