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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:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00261950
First received: December 2, 2005
Last updated: June 24, 2014
Last verified: June 2014
History of Changes

December 2, 2005
June 24, 2014
May 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: Baseline to week 52 ] [ 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
  • 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 ]
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 markers of bone turnover in patients with kidney disease who are receiving dialysis.
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.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Secondary Hyperparathyroidism
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.
Experimental: Cinacalcet
All subjects were enrolled into the single arm to receive Cinacalcet. There was no comparator arm.
Intervention: Drug: Sensipar (Cinacalcet HCl)

*   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 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®
Both
18 Years and older   (Adult, Senior)
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, IND #56,010
No
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
June 2014

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