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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00261950
First Posted: December 6, 2005
Last Update Posted: July 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP) [ Time Frame: Baseline to weeks 40-52 ]
  • Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP) [ Time Frame: Baseline to weeks 40-52 ]
  • Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP) [ Time Frame: Baseline to weeks 40-52 ]
  • Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52 [ Time Frame: Baseline to week 52 ]
  • Percent Change From Baseline in N - Telopeptide (NTx) at Week 52 [ Time Frame: Baseline to week 52 ]
  • Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP) [ Time Frame: Baseline to weeks 40-52 ]
  • Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter) [ Time Frame: Baseline to week 52 ]
    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 ]
    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 ]
    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 ]
    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 ]
  • Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52 [ Time Frame: Baseline to week 52 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261950


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

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00261950     History of Changes
Other Study ID Numbers: 20050104
BONAFIDE Study ( Other Identifier: Amgen )
IND #56,010 ( Other Identifier: Food and Drug Administration )
First Submitted: December 2, 2005
First Posted: December 6, 2005
Results First Submitted: October 7, 2013
Results First Posted: December 4, 2013
Last Update Posted: July 21, 2014
Last Verified: June 2014

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
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs