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

Secondary Hyperparathyroidism Clinical Trial

— BONAFIDE  

Official title:

Bone Histomorphometry Assessment For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261950
• Other study ID #: 20050104
• Secondary ID: BONAFIDE StudyIN
• Status: Completed
• Phase: Phase 2
• First received: December 2, 2005
• Last updated: June 24, 2014
• Start date: May 2006
• Est. completion date: May 2011

Study information

• Verified date: June 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: EU: CHMPUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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®

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Failure, Chronic
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

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.

Locations

Country	Name	City	State
Belgium	Research Site	Antwerpen
Belgium	Research Site	Antwerpen
Belgium	Research Site	Bruxelles
Belgium	Research Site	Leuven
Belgium	Research Site	Liege
Czech Republic	Research Site	Hradec Kralove
Czech Republic	Research Site	Praha 6
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Gyor
Hungary	Research Site	Miskolc
Hungary	Research Site	Nyiregyhaza
Italy	Research Site	Avellino
Italy	Research Site	Cremona
Italy	Research Site	Genova
Italy	Research Site	Milano
Italy	Research Site	Ortona CH
Italy	Research Site	Ostia RM
Italy	Research Site	Roma
Italy	Research Site	Roma
Italy	Research Site	Roma (RM)
Macedonia, The Former Yugoslav R	Research Site	Skopje
Poland	Research Site	Krakow
Poland	Research Site	Lodz
Poland	Research Site	Wroclaw
Portugal	Research Site	Almada
Portugal	Research Site	Estoril
Portugal	Research Site	Guimarães
Portugal	Research Site	Porto
Portugal	Research Site	Porto	PR
Portugal	Research Site	Vila Franca de Xira
Spain	Research Site	Alcorcón	Madrid
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Madrid
Spain	Research Site	Santander	Cantabria
Switzerland	Research Site	Zurich
Turkey	Research Site	Izmir
United Kingdom	Research Site	Manchester
United States	Research Site	Allentown	Pennsylvania
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bronx	New York
United States	Research Site	Denver	Colorado
United States	Research Site	Evanston	Illinois
United States	Research Site	Flushing	New York
United States	Research Site	Fort Lauderdale	Florida
United States	Research Site	Great Neck	New York
United States	Research Site	Houston	Texas
United States	Research Site	Los Angeles	California
United States	Research Site	New Haven	Connecticut
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New York	New York
United States	Research Site	Phoenix	Arizona
United States	Research Site	St Louis	Missouri
United States	Research Site	Teaneck	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Belgium,  Czech Republic,  Hungary,  Italy,  Macedonia, The Former Yugoslav Republic of,  Poland,  Portugal,  Spain,  Switzerland,  Turkey,  United Kingdom, 

References & Publications (2)

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. — View Citation

TBD.BONAFIDE Baseline/Primary Results.Journal-004521;

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to End of Study in Bone Formation Rate (BFR)		Baseline to week 52	No
Secondary	Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP)		Baseline to weeks 40-52	No
Secondary	Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP)		Baseline to weeks 40-52	No
Secondary	Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP)		Baseline to weeks 40-52	No
Secondary	Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52		Baseline to week 52	No
Secondary	Percent Change From Baseline in N - Telopeptide (NTx) at Week 52		Baseline to week 52	No
Secondary	Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP)		Baseline to weeks 40-52	No
Secondary	Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter)	Osteoblast Perimeter was calculated as "Osteoblast Perimeter/Osteoid Perimeter * 100"	Baseline to week 52	No
Secondary	Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter)	Osteoclast Perimeter was calculated as "Osteoclast Perimeter/Eroded Perimeter * 100"	Baseline to week 52	No
Secondary	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)	Baseline to week 52	No
Secondary	Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter	Eroded Perimeter/Bone Perimeter was calculated as "Eroded Perimeter/Bone Perimeter * 100"	Baseline to week 52	No
Secondary	Percent Change From Baseline in Osteocalcin (OC) at Week 52		Baseline to week 52	No
Secondary	Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52		Baseline to week 52	No

External Links

•   AmgenTrials clinical trials website