Clinical trial NCT00261950: Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
Official title: Bone Histomorphometry Assessment For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Secondary Hyperparathyroidism
Keywords: Cinacalcet HCl, Cinacalcet, Amgen (AMG) 073, Sensipar, Mimpara, Calcimimetic
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-12-06
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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®

Primary outcomes:
measure: Change From Baseline to End of Study in Bone Formation Rate (BFR)
timeFrame: Baseline to week 52
Secondary outcomes:
measure: Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP)
timeFrame: Baseline to weeks 40-52
measure: Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP)
timeFrame: Baseline to weeks 40-52
measure: Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP)
timeFrame: Baseline to weeks 40-52
measure: Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52
timeFrame: Baseline to week 52
measure: Percent Change From Baseline in N - Telopeptide (NTx) at Week 52
timeFrame: Baseline to week 52
measure: Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP)
timeFrame: Baseline to weeks 40-52
measure: Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter)
timeFrame: Baseline to week 52
measure: Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter)
timeFrame: Baseline to week 52
measure: Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
timeFrame: Baseline to week 52
measure: Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter
timeFrame: Baseline to week 52
measure: Percent Change From Baseline in Osteocalcin (OC) at Week 52
timeFrame: Baseline to week 52
measure: Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52
timeFrame: Baseline to week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: New Haven
country: United States
facility: Research Site
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Research Site
state: Florida
city: Evanston
country: United States
facility: Research Site
state: Illinois
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: St Louis
country: United States
facility: Research Site
state: Missouri
city: Teaneck
country: United States
facility: Research Site
state: New Jersey
city: Bronx
country: United States
facility: Research Site
state: New York
city: Flushing
country: United States
facility: Research Site
state: New York
city: Great Neck
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Allentown
country: United States
facility: Research Site
state: Pennsylvania
city: Houston
country: United States
facility: Research Site
state: Texas
city: Antwerpen
country: Belgium
facility: Research Site
city: Antwerpen
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Praha 6
country: Czech Republic
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Avellino
country: Italy
facility: Research Site
city: Cremona
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Ortona CH
country: Italy
facility: Research Site
city: Ostia RM
country: Italy
facility: Research Site
city: Roma (RM)
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
state: PR
city: Almada
country: Portugal
facility: Research Site
city: Estoril
country: Portugal
facility: Research Site
city: GuimarÃ£es
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Vila Franca de Xira
country: Portugal
facility: Research Site
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: AlcorcÃ³n
country: Spain
facility: Research Site
state: Madrid
city: Madrid
country: Spain
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: TBD.BONAFIDE Baseline/Primary Results.Journal-004521;
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.