Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease (BONAFIDE)
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ClinicalTrials.gov Identifier: NCT00261950 |
Recruitment Status
:
Completed
First Posted
: December 6, 2005
Results First Posted
: December 4, 2013
Last Update Posted
: July 21, 2014
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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Tracking Information | ||||
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First Submitted Date ICMJE | December 2, 2005 | |||
First Posted Date ICMJE | December 6, 2005 | |||
Results First Submitted Date | October 7, 2013 | |||
Results First Posted Date | December 4, 2013 | |||
Last Update Posted Date | July 21, 2014 | |||
Study Start Date ICMJE | May 2006 | |||
Actual Primary Completion Date | May 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change From Baseline to End of Study in Bone Formation Rate (BFR) [ Time Frame: Baseline to week 52 ] | |||
Original Primary Outcome Measures ICMJE |
Change from baseline in bone turnover parameters | |||
Change History | Complete list of historical versions of study NCT00261950 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Changes in bone turnover parameters at one year; safety and tolerability of cinacalcet at one year. | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease | |||
Official Title ICMJE | Bone Histomorphometry Assessment For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease | |||
Brief Summary | 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. | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Secondary Hyperparathyroidism | |||
Intervention ICMJE | 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. |
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Study Arms | Experimental: Cinacalcet
All subjects were enrolled into the single arm to receive Cinacalcet. There was no comparator arm.
Intervention: Drug: Sensipar (Cinacalcet HCl) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
110 | |||
Original Enrollment ICMJE |
85 | |||
Actual Study Completion Date | May 2011 | |||
Actual Primary Completion Date | May 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Subjects will be eligible for the study if they meet all of the following criteria:
Exclusion Criteria: Subjects will be ineligible for the study if they:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Czech Republic, Hungary, Italy, Macedonia, The Former Yugoslav Republic of, Poland, Portugal, Spain, Switzerland, Turkey, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00261950 | |||
Other Study ID Numbers ICMJE | 20050104 BONAFIDE Study ( Other Identifier: Amgen ) IND #56,010 ( Other Identifier: Food and Drug Administration ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Amgen | |||
Study Sponsor ICMJE | Amgen | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Amgen | |||
Verification Date | June 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |