Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Subjects With PHPT Unable to Undergo Parathyroidectomy
Summary
This phase 3, randomized, double-blind, placebo-controlled study is designed to demonstrate the efficacy and to assess the safety of cinacalcet for the reduction of hypercalcemia in subjects with primary HPT for whom parathyroidectomy is indicated on the basis of an elevated corrected total serum calcium, but who are unable to undergo parathyroidectomy. The reasons a subject would be unable to undergo parathyroidectomy include failed parathyroidectomy, medical contraindication to surgery, or because together with their primary physician they decided it was inappropriate. The study will consist of a 30-day screening phase, a 12-week placebo-controlled dose-titration phase, and a 16 week placebo-controlled efficacy assessment phase (EAP). Subjects who complete 28 weeks on study will continue into an open-label safety extension phase for 24 weeks of investigational cinacalcet treatment.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Hyperparathyroidism, Primary
Intervention
cinacalcet HCl, Placebo
Location
Research Site
Lake Forest
California
United States
Status
Recruiting
Source
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00975221
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:19:24-0400
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Medical and Biotech [MESH] Definitions
Hyperparathyroidism
A condition of abnormally elevated output of PARATHYROID HORMONE (or PTH) triggering responses that increase blood CALCIUM. It is characterized by HYPERCALCEMIA and BONE RESORPTION, eventually leading to bone diseases. PRIMARY HYPERPARATHYROIDISM is caused by parathyroid HYPERPLASIA or PARATHYROID NEOPLASMS. SECONDARY HYPERPARATHYROIDISM is increased PTH secretion in response to HYPOCALCEMIA, usually caused by chronic KIDNEY DISEASES.
Hyperparathyroidism, Primary
A condition of abnormally elevated output of PARATHYROID HORMONE due to parathyroid HYPERPLASIA or PARATHYROID NEOPLASMS. It is characterized by the combination of HYPERCALCEMIA, phosphaturia, elevated renal 1,25-DIHYDROXYVITAMIN D3 synthesis, and increased BONE RESORPTION.
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Placebo Effect
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Cinacalcet Hydrochloride
A naphthalene derivative and CALCIMIMETIC AGENT that increases the sensitivity of PARATHYROID GLAND calcium-sensing receptors to serum calcium. This action reduces parathyroid hormone secretion and decreases serum calcium in the treatment of PARATHYROID DISEASES.
