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.
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
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
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.
Change From Baseline to End of Study in Bone Formation Rate (BFR)
Time frame: Baseline to week 52
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)
Osteoblast Perimeter was calculated as "Osteoblast Perimeter/Osteoid Perimeter \* 100"
Time frame: Baseline to week 52
Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter)
Osteoclast Perimeter was calculated as "Osteoclast Perimeter/Eroded Perimeter \* 100"
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Research Site
Phoenix, Arizona, United States
Research Site
Los Angeles, California, United States
Research Site
Denver, Colorado, United States
Research Site
New Haven, Connecticut, United States
Research Site
Fort Lauderdale, Florida, United States
Research Site
Evanston, Illinois, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Baltimore, Maryland, United States
Research Site
St Louis, Missouri, United States
Research Site
Teaneck, New Jersey, United States
...and 45 more locations
Time frame: Baseline to week 52
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)
Time frame: Baseline to week 52
Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter
Eroded Perimeter/Bone Perimeter was calculated as "Eroded Perimeter/Bone Perimeter \* 100"
Time frame: Baseline to week 52
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