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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00261950
First received: December 2, 2005
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: 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: Baseline to week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]
  • Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52 [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in N - Telopeptide (NTx) at Week 52 [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP) [ Time Frame: Baseline to weeks 40-52 ] [ Designated as safety issue: No ]
  • Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter) [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
    Osteoblast Perimeter was calculated as "Osteoblast Perimeter/Osteoid Perimeter * 100"

  • Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter) [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
    Osteoclast Perimeter was calculated as "Osteoclast Perimeter/Eroded Perimeter * 100"

  • Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
    Categorisation at each timepoint was based on fibrosis area as a percentage of tissue area (Fibrosis Area/Tissue Area * 100)

  • Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
    Eroded Perimeter/Bone Perimeter was calculated as "Eroded Perimeter/Bone Perimeter * 100"

  • Percent Change From Baseline in Osteocalcin (OC) at Week 52 [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52 [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: May 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cinacalcet
All subjects were enrolled into the single arm to receive Cinacalcet. There was no comparator arm.
Drug: Sensipar (Cinacalcet HCl)
All enrolled subjects receive study medication at a starting dose of 30 mg cinacalcet once daily beginning on day 1. Possible sequential doses are 30 mg, 60mg, 90mg, 120mg, 180 mg taken once daily. During the study, dose adjustment (dose increase/decrease/withholding) is based upon iPTH, serum calcium, and subject safety information. Subjects swallowed tablets whole without biting or chewing. Subjects were dispensed investigational product every 4 weeks starting from Day 1 through to Week 48.

Detailed Description:

Secondary hyperparathyroidism (HPT) is common in people with end stage renal disease (kidney disease). Patients with secondary HPT often have enlarged parathyroid glands in the neck and as a result often have elevated parathyroid hormone (PTH) levels . Patients with secondary HPT may have bone disease (osteodystrophy). Cinacalcet has been used to decrease PTH levels in patients with secondary HPT. Patients with secondary HPT may have bone disease (osteodystrophy). This bone disease may cause bone pain, fractures, and poor formation of red blood cells. The purpose of this study is to evaluate effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.

  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 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®
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Amgen
ClinicalTrials.gov Identifier: NCT00261950     History of Changes
Other Study ID Numbers: 20050104, BONAFIDE Study, IND #56,010
Study First Received: December 2, 2005
Results First Received: October 7, 2013
Last Updated: June 24, 2014
Health Authority: EU: CHMP
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Kidney Diseases
Kidney Failure, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014