Phase 2
Completed N=110
Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
Source: ClinicalTrials.gov NCT00261950 ↗Enrolled (actual)
110
Serious AEs
40.9%
Results posted
Dec 2013
Primary outcomePrimary: Change From Baseline to End of Study in Bone Formation Rate (BFR) — -488 μm^2/mm^2/day
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to End of Study in Bone Formation Rate (BFR) |
-488 | — |
| SECONDARY Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP) |
-6.5 | — |
| SECONDARY Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP) |
-1.1 | — |
| SECONDARY Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP) |
-6.9 | — |
| SECONDARY Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52 |
6.6 | — |
| SECONDARY Percent Change From Baseline in N - Telopeptide (NTx) at Week 52 |
-14.0 | — |
| SECONDARY Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP) |
-41.6 | — |
| SECONDARY Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter) |
-4.3 | — |
| SECONDARY Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter) |
-2.7 | — |
| SECONDARY Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area |
3; 3; 0; 0; 0; 17 | — |
| SECONDARY Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter |
-3.4 | — |
| SECONDARY Percent Change From Baseline in Osteocalcin (OC) at Week 52 |
-21.8 | — |
| SECONDARY Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52 |
-3.8 | — |
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®
Data sourced from ClinicalTrials.gov (NCT00261950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.