Phase 2
N=110
Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
Secondary Hyperparathyroidism
Bottom Line
View on ClinicalTrials.gov: NCT00261950 ↗Enrolled (actual)
110
Serious AEs
40.9%
Results posted
Dec 2013
Primary outcome: Primary: Change From Baseline to End of Study in Bone Formation Rate (BFR) — -488 μm^2/mm^2/day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sensipar (Cinacalcet HCl) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- May 2011
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 | — |
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.
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.