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

Study Overview
=================
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.

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

Conditions
-----------------
Secondary Hyperparathyroidism

Intervention / Treatment
-----------------
* Drug: Sensipar (Cinacalcet HCl)


Participation Criteria
=================
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®

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cinacalcet<br>All subjects were enrolled into the single arm to receive Cinacalcet. There was no comparator arm. | Drug: Sensipar (Cinacalcet HCl)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to End of Study in Bone Formation Rate (BFR) |  | Baseline to week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP) |  | Baseline to weeks 40-52 | 
| Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP) |  | Baseline to weeks 40-52 | 
| Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP) |  | Baseline to weeks 40-52 | 
| Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52 |  | Baseline to week 52 | 
| Percent Change From Baseline in N - Telopeptide (NTx) at Week 52 |  | Baseline to week 52 | 
| Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP) |  | 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 | 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 | 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) | 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 | Baseline to week 52 | 
| Percent Change From Baseline in Osteocalcin (OC) at Week 52 |  | Baseline to week 52 | 
| Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52 |  | Baseline to week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cinacalcet HCl, Cinacalcet, Amgen (AMG) 073, Sensipar, Mimpara, Calcimimetic