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

Tracking Information
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; (submitted: June 24, 2014)	Change From Baseline to End of Study in Bone Formation Rate (BFR) [ Time Frame: Baseline to week 52 ]
Original Primary Outcome Measures ICMJE; (submitted: December 2, 2005)	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; (submitted: June 24, 2014)	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 ]
Original Secondary Outcome Measures ICMJE; (submitted: December 2, 2005)	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
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.
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)
Publications *	TBD.BONAFIDE Baseline/Primary Results.Journal-004521;; Behets GJ, Spasovski G, Sterling LR, Goodman WG, Spiegel DM, De Broe ME, D'Haese PC. Bone histomorphometry before and after long-term treatment with cinacalcet in dialysis patients with secondary hyperparathyroidism. Kidney Int. 2015 Apr;87(4):846-56. doi: 10.1038/ki.2014.349. Epub 2014 Oct 22.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 25, 2011)	110
Original Enrollment ICMJE; (submitted: December 2, 2005)	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: 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®
Sex/Gender	Sexes Eligible for Study: All
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 )
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	Study Director: MD Amgen
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