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
  Purpose

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.


Condition Intervention Phase
Secondary Hyperparathyroidism
Drug: Sensipar (Cinacalcet HCl)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bone Histomorphometry Assessment For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Change From Baseline to End of Study in Bone Formation Rate (BFR) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 110
Study Start Date: January 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
100% of subjects on study (85 subjects)
Drug: Sensipar (Cinacalcet HCl)
30 mg, 60mg, 90mg, 120mg, 180 mg taken once daily

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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®
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261950

  Show 55 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00261950     History of Changes
Other Study ID Numbers: 20050104, BONAFIDE Study
Study First Received: December 2, 2005
Results First Received: October 7, 2013
Last Updated: October 7, 2013
Health Authority: EU: CHMP
United States: Food and Drug Administration

Keywords provided by Amgen:
Cinacalcet HCl, Cinacalcet, AMG 073, Sensipar, Mimpara, Calcimimetic

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Kidney Failure, Chronic
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on April 23, 2014