PMID- 25637076
OWN - NLM
STAT- MEDLINE
DCOM- 20150522
LR  - 20220321
IS  - 1479-683X (Electronic)
IS  - 0804-4643 (Print)
IS  - 0804-4643 (Linking)
VI  - 172
IP  - 5
DP  - 2015 May
TI  - Cinacalcet normalizes serum calcium in a double-blind randomized, 
      placebo-controlled study in patients with primary hyperparathyroidism with 
      contraindications to surgery.
PG  - 527-35
LID - 10.1530/EJE-14-0877 [doi]
AB  - OBJECTIVE: Primary hyperparathyroidism (PHPT) is diagnosed by the presence of 
      hypercalcemia and elevated or nonsuppressed parathyroid hormone (PTH) levels. 
      Although surgery is usually curative, some individuals fail or are unable or 
      unwilling to undergo parathyroidectomy. In such individuals, targeted medical 
      therapy may be of value. Cinacalcet normalized calcium level and lowered PTH in 
      patients with PHPT in several phase 2 and open-label studies. We compared 
      cinacalcet and placebo in subjects with PHPT unable to undergo parathyroidectomy. 
      DESIGN: Phase 3, double-blind, multi centere, randomized, placebo-controlled 
      study. METHODS: Sixty-seven subjects (78% women) with moderate PHPT were 
      randomized (1:1) to cinacalcet or placebo for </=28 weeks. MAIN OUTCOME MEASURE: 
      Achievement of a normal mean corrected total serum calcium concentration of 
      </=10.3 mg/dl (2.575 mmol/l). RESULTS: Baseline median (quartile 1 (Q1), Q3) serum 
      PTH was 164.0 (131.0, 211.0) pg/ml and mean (s.d.) serum Ca was 11.77 (0.46) 
      mg/dl. Serum Ca normalized (</=10.3 mg/dl) in 75.8% of cinacalcet- vs 0% of 
      placebo-treated subjects (P<0.001). Corrected serum Ca decreased by >/=1.0 mg/dl 
      from baseline in 84.8% of cinacalcet- vs 5.9% of placebo-treated subjects 
      (P<0.001). Least squares mean (s.e.m.) plasma PTH change from baseline was 
      -23.80% (4.18%) (cinacalcet) vs -1.01% (4.05%) (placebo) (P<0.001). Similar 
      numbers of subjects in the cinacalcet and placebo groups reported adverse events 
      (AEs) (27 vs 20) and serious AEs (three vs four). Most commonly reported AEs were 
      nausea and muscle spasms. CONCLUSIONS: These results demonstrate that cinacalcet 
      normalizes serum calcium in this PHPT population and appears to be well 
      tolerated.
CI  - (c) 2015 European Society of Endocrinology.
FAU - Khan, Aliya
AU  - Khan A
AD  - Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon 
      Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and 
      SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral 
      ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of 
      MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of 
      EndocrinologyMedical Centre of Postgraduate Education, Warsaw, 
      PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, 
      California, USA2nd Department of MedicineSemmelweis University, Budapest, Hungary 
      draliyakhan@gmail.com.
FAU - Bilezikian, John
AU  - Bilezikian J
AD  - Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon 
      Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and 
      SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral 
      ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of 
      MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of 
      EndocrinologyMedical Centre of Postgraduate Education, Warsaw, 
      PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, 
      California, USA2nd Department of MedicineSemmelweis University, Budapest, 
      Hungary.
FAU - Bone, Henry
AU  - Bone H
AD  - Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon 
      Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and 
      SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral 
      ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of 
      MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of 
      EndocrinologyMedical Centre of Postgraduate Education, Warsaw, 
      PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, 
      California, USA2nd Department of MedicineSemmelweis University, Budapest, 
      Hungary.
FAU - Gurevich, Andrey
AU  - Gurevich A
AD  - Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon 
      Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and 
      SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral 
      ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of 
      MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of 
      EndocrinologyMedical Centre of Postgraduate Education, Warsaw, 
      PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, 
      California, USA2nd Department of MedicineSemmelweis University, Budapest, 
      Hungary.
FAU - Lakatos, Peter
AU  - Lakatos P
AD  - Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon 
      Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and 
      SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral 
      ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of 
      MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of 
      EndocrinologyMedical Centre of Postgraduate Education, Warsaw, 
      PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, 
      California, USA2nd Department of MedicineSemmelweis University, Budapest, 
      Hungary.
FAU - Misiorowski, Waldemar
AU  - Misiorowski W
AD  - Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon 
      Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and 
      SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral 
      ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of 
      MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of 
      EndocrinologyMedical Centre of Postgraduate Education, Warsaw, 
      PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, 
      California, USA2nd Department of MedicineSemmelweis University, Budapest, 
      Hungary.
FAU - Rozhinskaya, Liudmila
AU  - Rozhinskaya L
AD  - Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon 
      Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and 
      SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral 
      ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of 
      MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of 
      EndocrinologyMedical Centre of Postgraduate Education, Warsaw, 
      PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, 
      California, USA2nd Department of MedicineSemmelweis University, Budapest, 
      Hungary.
FAU - Trotman, Marie-Louise
AU  - Trotman ML
AD  - Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon 
      Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and 
      SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral 
      ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of 
      MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of 
      EndocrinologyMedical Centre of Postgraduate Education, Warsaw, 
      PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, 
      California, USA2nd Department of MedicineSemmelweis University, Budapest, 
      Hungary.
FAU - Toth, Miklos
AU  - Toth M
AD  - Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon 
      Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and 
      SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral 
      ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of 
      MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of 
      EndocrinologyMedical Centre of Postgraduate Education, Warsaw, 
      PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, 
      California, USA2nd Department of MedicineSemmelweis University, Budapest, 
      Hungary.
LA  - eng
GR  - R01 DK032333/DK/NIDDK NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150130
PL  - England
TA  - Eur J Endocrinol
JT  - European journal of endocrinology
JID - 9423848
RN  - 0 (Naphthalenes)
RN  - 27YLU75U4W (Phosphorus)
RN  - UAZ6V7728S (Cinacalcet)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Cinacalcet
MH  - Contraindications
MH  - Double-Blind Method
MH  - Endpoint Determination
MH  - Female
MH  - Humans
MH  - Hypercalcemia/blood/*drug therapy/*etiology
MH  - Hyperparathyroidism/*blood/complications/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Naphthalenes/adverse effects/*therapeutic use
MH  - *Parathyroidectomy
MH  - Phosphorus/blood
PMC - PMC5729741
MID - NIHMS854461
EDAT- 2015/02/01 06:00
MHDA- 2015/05/23 06:00
PMCR- 2017/12/14
CRDT- 2015/02/01 06:00
PHST- 2015/02/01 06:00 [entrez]
PHST- 2015/02/01 06:00 [pubmed]
PHST- 2015/05/23 06:00 [medline]
PHST- 2017/12/14 00:00 [pmc-release]
AID - EJE-14-0877 [pii]
AID - 10.1530/EJE-14-0877 [doi]
PST - ppublish
SO  - Eur J Endocrinol. 2015 May;172(5):527-35. doi: 10.1530/EJE-14-0877. Epub 2015 Jan 
      30.