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
Amgen
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00975221
- Information obtained from ClinicalTrials.gov on July 15, 2010
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.
Osteitis Fibrosa Cystica
A fibrous degeneration, cyst formation, and the presence of fibrous nodules in bone, usually due to HYPERPARATHYROIDISM.
Clinical Trials
E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events
The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD) patients with...
This is a multicentre, descriptive observational study of adult patients with primary HPT receiving cinacalcet in clinical practice in a number of countries in Europe (including Russia)....
Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
The 1st phase of the study will assess the acute biochemical response of PTH, calcium and phosphorus to orally administered doses of cinacalcet once (60mg) or twice (30mg x 2) per day....
The purpose of this study is to demonstrate that the efficacy of cinacalcet when co-administered with the first meal after dialysis is comparable (non-inferior) to the efficacy of cinacalc...
This study is designed in order to investigate the effect of cinacalcet in combination with routine conventional medical management for treatment of secondary hyperparathyroidism (SHPT) an...
PubMed Articles
Background/Aim: Cinacalcet, an allosteric modulator of the calcium sensing receptor, effectively reduces serum parathyroid hormone (PTH) in patients with secondary hyperparathyroidism. It is not well...
Cinacalcet is effective in controlling the biochemical abnormalities in patients with primary hyperparathyroidism (PHPT) but it seems to be less effective on bone mineral density (BMD). In the same pa...
BACKGROUND AND OBJECTIVES: Cinacalcet is effective in reducing serum parathyroid hormone (PTH) in patients with secondary hyperparathyroidism. However, it has not been proven whether parathyroid gland...
Cinacalcet HCl (cinacalcet) is a calcimimetic compound, which suppresses parathyroid (PTH) hormone secretion from parathyroid glands in both primary hyperparathyroidism (PHPT) and secondary hyperparat...
Cinacalcet reduces parathyroid hormone (PTH) levels in uremic hyperparathyroidism (HPT), and in renal transplantation it is useful in the management of HPT with hypercalcemia. Our main aim is to evalu...
