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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
Results First Received: October 7, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Secondary Hyperparathyroidism
Intervention: Drug: Sensipar (Cinacalcet HCl)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
May 22 2006 is study initiation date and 13 May 2011 is study completion date.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cinacalcet cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.

Participant Flow:   Overall Study
    Cinacalcet  
STARTED     110  
COMPLETED     84  
NOT COMPLETED     26  
Lost to Follow-up                 2  
Death                 6  
Withdrawal by Subject                 5  
not specified                 1  
Physician Decision                 1  
Protocol specified Criteria                 11  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cinacalcet cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.

Baseline Measures
    Cinacalcet  
Number of Participants  
[units: participants]
  110  
Age  
[units: years]
Mean ± Standard Deviation
  55.2  ± 14.2  
Gender  
[units: Participants]
 
Female     40  
Male     70  
Race/Ethnicity, Customized  
[units: Participants]
 
White     91  
Black     10  
Other     9  



  Outcome Measures
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1.  Primary:   Change From Baseline to End of Study in Bone Formation Rate (BFR)   [ Time Frame: Baseline to week 52 ]

2.  Secondary:   Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP)   [ Time Frame: Baseline to weeks 40-52 ]

3.  Secondary:   Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP)   [ Time Frame: Baseline to weeks 40-52 ]

4.  Secondary:   Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP)   [ Time Frame: Baseline to weeks 40-52 ]

5.  Secondary:   Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52   [ Time Frame: Baseline to week 52 ]

6.  Secondary:   Percent Change From Baseline in N – Telopeptide (NTx) at Week 52   [ Time Frame: Baseline to week 52 ]

7.  Secondary:   Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP)   [ Time Frame: Baseline to weeks 40-52 ]

8.  Secondary:   Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter)   [ Time Frame: Baseline to week 52 ]

9.  Secondary:   Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter)   [ Time Frame: Baseline to week 52 ]

10.  Secondary:   Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area   [ Time Frame: Baseline to week 52 ]

11.  Secondary:   Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter   [ Time Frame: Baseline to week 52 ]

12.  Secondary:   Percent Change From Baseline in Osteocalcin (OC) at Week 52   [ Time Frame: Baseline to week 52 ]

13.  Secondary:   Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52   [ Time Frame: Baseline to week 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


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