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

  Hide Study Locations
Locations
United States, Arizona
Research Site
Phoenix, Arizona, United States, 85012
United States, California
Research Site
Los Angeles, California, United States, 90095
United States, Colorado
Research Site
Denver, Colorado, United States, 80220
United States, Connecticut
Research Site
New Haven, Connecticut, United States, 06511
United States, Florida
Research Site
Fort Lauderdale, Florida, United States, 33334
United States, Illinois
Research Site
Evanston, Illinois, United States, 60201
United States, Louisiana
Research Site
New Orleans, Louisiana, United States, 70121
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21205
United States, Missouri
Research Site
St Louis, Missouri, United States, 63110
United States, New Jersey
Research Site
Teaneck, New Jersey, United States, 07666
United States, New York
Research Site
Bronx, New York, United States, 10467
Research Site
Flushing, New York, United States, 11355
Research Site
Great Neck, New York, United States, 11021
Research Site
New York, New York, United States, 10032
United States, Pennsylvania
Research Site
Allentown, Pennsylvania, United States, 18103
United States, Texas
Research Site
Houston, Texas, United States, 77076
Belgium
Research Site
Antwerpen, Belgium, 2020
Research Site
Antwerpen, Belgium, 2060
Research Site
Bruxelles, Belgium, 1070
Research Site
Leuven, Belgium, 3000
Research Site
Liege, Belgium, 4000
Czech Republic
Research Site
Hradec Kralove, Czech Republic, 500 05
Research Site
Praha 6, Czech Republic, 169 00
Hungary
Research Site
Budapest, Hungary, 1083
Research Site
Debrecen, Hungary, 4012
Research Site
Gyor, Hungary, 9023
Research Site
Miskolc, Hungary, 3526
Research Site
Nyiregyhaza, Hungary, 4400
Italy
Research Site
Avellino, Italy, 83100
Research Site
Cremona, Italy, 26100
Research Site
Genova, Italy, 16132
Research Site
Milano, Italy, 20162
Research Site
Ortona CH, Italy, 66026
Research Site
Ostia RM, Italy, 00122
Research Site
Roma, Italy, 00184
Research Site
Roma, Italy, 00149
Research Site
Roma (RM), Italy, 00133
Macedonia, The Former Yugoslav Republic of
Research Site
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Poland
Research Site
Krakow, Poland, 31-501
Research Site
Lodz, Poland, 90-153
Research Site
Wroclaw, Poland, 50-556
Portugal
Research Site
Porto, PR, Portugal, 4250-499
Research Site
Almada, Portugal, 2800-455
Research Site
Estoril, Portugal, 2765-294
Research Site
Guimarães, Portugal, 4810-273
Research Site
Porto, Portugal, 4200-072
Research Site
Vila Franca de Xira, Portugal, 2600-076
Spain
Research Site
Santander, Cantabria, Spain, 39008
Research Site
Barcelona, Cataluña, Spain, 08003
Research Site
Barcelona, Cataluña, Spain, 08036
Research Site
Alcorcón, Madrid, Spain, 28922
Research Site
Madrid, Spain, 28046
Switzerland
Research Site
Zurich, Switzerland, 8091
Turkey
Research Site
Izmir, Turkey, 35360
United Kingdom
Research Site
Manchester, United Kingdom, M13 9WL
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:
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 July 28, 2014