Back to resultsBone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease (BONAFIDE)
Primary Purpose
Secondary Hyperparathyroidism
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sensipar (Cinacalcet HCl)
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Cinacalcet HCl, Cinacalcet, Amgen (AMG) 073, Sensipar, Mimpara, Calcimimetic
Eligibility 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®
Sites / Locations
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cinacalcet
Arm Description
All subjects were enrolled into the single arm to receive Cinacalcet. There was no comparator arm.
Outcomes
Primary Outcome Measures
Change From Baseline to End of Study in Bone Formation Rate (BFR)
Secondary Outcome Measures
Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP)
Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP)
Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP)
Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52
Percent Change From Baseline in N - Telopeptide (NTx) at Week 52
Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP)
Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter)
Osteoblast Perimeter was calculated as "Osteoblast Perimeter/Osteoid Perimeter * 100"
Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter)
Osteoclast Perimeter was calculated as "Osteoclast Perimeter/Eroded Perimeter * 100"
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
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
Eroded Perimeter/Bone Perimeter was calculated as "Eroded Perimeter/Bone Perimeter * 100"
Percent Change From Baseline in Osteocalcin (OC) at Week 52
Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00261950
Brief Title
Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
Acronym
BONAFIDE
Official Title
Bone Histomorphometry Assessment For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism
Keywords
Cinacalcet HCl, Cinacalcet, Amgen (AMG) 073, Sensipar, Mimpara, Calcimimetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cinacalcet
Arm Type
Experimental
Arm Description
All subjects were enrolled into the single arm to receive Cinacalcet. There was no comparator arm.
Intervention Type
Drug
Intervention Name(s)
Sensipar (Cinacalcet HCl)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline to End of Study in Bone Formation Rate (BFR)
Time Frame
Baseline to week 52
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP)
Time Frame
Baseline to weeks 40-52
Title
Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP)
Time Frame
Baseline to weeks 40-52
Title
Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP)
Time Frame
Baseline to weeks 40-52
Title
Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52
Time Frame
Baseline to week 52
Title
Percent Change From Baseline in N - Telopeptide (NTx) at Week 52
Time Frame
Baseline to week 52
Title
Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP)
Time Frame
Baseline to weeks 40-52
Title
Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter)
Description
Osteoblast Perimeter was calculated as "Osteoblast Perimeter/Osteoid Perimeter * 100"
Time Frame
Baseline to week 52
Title
Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter)
Description
Osteoclast Perimeter was calculated as "Osteoclast Perimeter/Eroded Perimeter * 100"
Time Frame
Baseline to week 52
Title
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Description
Categorisation at each timepoint was based on fibrosis area as a percentage of tissue area (Fibrosis Area/Tissue Area * 100)
Time Frame
Baseline to week 52
Title
Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter
Description
Eroded Perimeter/Bone Perimeter was calculated as "Eroded Perimeter/Bone Perimeter * 100"
Time Frame
Baseline to week 52
Title
Percent Change From Baseline in Osteocalcin (OC) at Week 52
Time Frame
Baseline to week 52
Title
Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52
Time Frame
Baseline to week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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®
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Research Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Research Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Research Site
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research Site
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Research Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Research Site
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Research Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Research Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77076
Country
United States
Facility Name
Research Site
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Research Site
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Research Site
City
Praha 6
ZIP/Postal Code
169 00
Country
Czech Republic
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Research Site
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Research Site
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Research Site
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Facility Name
Research Site
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Research Site
City
Ortona CH
ZIP/Postal Code
66026
Country
Italy
Facility Name
Research Site
City
Ostia RM
ZIP/Postal Code
00122
Country
Italy
Facility Name
Research Site
City
Roma (RM)
ZIP/Postal Code
00133
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00149
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00184
Country
Italy
Facility Name
Research Site
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Research Site
City
Porto
State/Province
PR
ZIP/Postal Code
4250-499
Country
Portugal
Facility Name
Research Site
City
Almada
ZIP/Postal Code
2800-455
Country
Portugal
Facility Name
Research Site
City
Estoril
ZIP/Postal Code
2765-294
Country
Portugal
Facility Name
Research Site
City
Guimarães
ZIP/Postal Code
4810-273
Country
Portugal
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Research Site
City
Vila Franca de Xira
ZIP/Postal Code
2600-076
Country
Portugal
Facility Name
Research Site
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08003
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Site
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35360
Country
Turkey
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
12. IPD Sharing Statement
Citations:
Citation
TBD.BONAFIDE Baseline/Primary Results.Journal-004521;
Results Reference
background
PubMed Identifier
25337774
Citation
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.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
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