Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy
A Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Cinacalcet for the Treatment of Hypercalcemia in Subjects With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy
1 other identifier
interventional
67
7 countries
47
Brief Summary
This study is designed to demonstrate the efficacy and to assess the safety of cinacalcet for the reduction of hypercalcemia in patients with primary hyperparathyroidism for whom parathyroidectomy is indicated on the basis of an elevated corrected total serum calcium, but who are unable to undergo parathyroidectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2010
Typical duration for phase_3
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2009
CompletedFirst Posted
Study publicly available on registry
September 11, 2009
CompletedStudy Start
First participant enrolled
March 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2012
CompletedResults Posted
Study results publicly available
January 25, 2016
CompletedOctober 17, 2018
September 1, 2018
2.3 years
September 10, 2009
December 17, 2015
September 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Mean Corrected Total Serum Calcium Concentration ≤ 10.3 mg/dL (2.57 mmol/L) During the EAP
Efficacy assessment phase (study visits at Weeks 16, 20, 24, and 28)
Secondary Outcomes (3)
Percentage of Participants With a ≥ 1 mg/dL (0.25 mmol/L) Decrease From Baseline in Mean Corrected Total Serum Calcium Concentration During the EAP
Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)
Percent Change From Baseline in Corrected Total Serum Calcium Concentration During the EAP
Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)
Percent Change From Baseline in Plasma Parathyroid Hormone Level During the EAP
Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)
Study Arms (2)
Cinacalcet
EXPERIMENTALParticipants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
Placebo
PLACEBO COMPARATORParticipants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
Interventions
Administered orally at a starting dose of 30 mg twice a day (BID). Participants will be eligible for a dose titration once every 3 weeks during the placebo-controlled dose titration phase based on corrected total serum calcium concentration and safety assessments obtained the previous week. Doses may be sequentially increased to 60 mg BID, 90 mg BID, and 90 mg 3 times a day (TID).
Administered orally following the same tiitration regimen as the experimental arm.
Eligibility Criteria
You may qualify if:
- age ≥ 18 years
- diagnosis of primary hyperparathyroidism (HPT)
- subjects must have the following laboratory values:
- local/historical laboratory result showing a corrected total serum calcium \> 1 mg/dL (0.25 mmol/L) above the upper limit of normal and
- ≤ 12.5 mg/dL (3.12 mmol/L) within the past 12 months, and
- local/historical laboratory result showing a plasma parathyroid horone (PTH) \> 75% of upper limit of normal within the past 12 months, and
- one central laboratory draw at the screen visit showing a corrected total serum calcium \> 11.3 mg/dL (2.82 mmol/L) and ≤ 12.5 mg/dL (3.12 mmol/L), and
- one central laboratory draw at the screen visit showing a plasma PTH \> 55 pg/mL (5.8 pmol/L) OR
- two central laboratory draws performed during the screening period at least 7 days apart, showing a
- corrected total serum calcium \> 11.3 mg/dL (2.82 mmol/L) and ≤ 12.5 mg/dL (3.12 mmol/L), and
- plasma PTH \> 55 pg/mL (5.8 pmol/L)
- not able to undergo parathyroidectomy for ≥ 1 of the following reasons:
- failed parathyroidectomy
- comorbid conditions contraindicating parathyroidectomy
- parathyroidectomy not considered appropriate or is not feasible by primary physician and subject
- +1 more criteria
You may not qualify if:
- symptoms attributable to hypercalcemia, requiring immediate medical intervention, as judged by the investigator (including acute kidney stone, nausea and vomiting requiring intravenous hydration, confusion, lethargy, stupor, or coma)
- unstable medical condition, defined as having been hospitalized within 30 days before the date of informed consent, or otherwise unstable in the judgment of the investigator
- administration of drugs that increase serum calcium concentration, including but not limited to thiazide diuretics or lithium
- initiated bisphosphonate therapy or changed bisphosphonate dose within 12 weeks before the date of informed consent
- current administration of drugs for ventricular arrhythmia
- unable to provide informed consent, or is at risk for poor compliance with study procedures
- currently enrolled in another investigational device or drug study(s), or completed such study within 30 days before the date of informed consent
- known hypersensitivity to or unable to tolerate cinacalcet
- received treatment with cinacalcet within 60 days before the date of informed consent
- history of seizures or an adjustment of anti-seizure medication within 12 weeks before the date of informed consent
- family history or diagnosis a genetic syndrome, such as familial benign hypocalciuric hypercalcemia (FBHH) or multiple endocrine neoplasia type 1 (MEN1) and type 2 (MEN2), where primary HPT is one of the clinical manifestations of familial benign hypocalciuric hypercalcemia (FBHH)
- refused to use highly effective contraceptive measures (as determined by the investigator) throughout the study
- pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (47)
Research Site
Lake Forest, California, 92630, United States
Research Site
Lancaster, California, 93534, United States
Research Site
Los Gatos, California, 95032, United States
Research Site
Mission Viejo, California, 92691, United States
Research Site
Orange, California, 92869, United States
Research Site
San Diego, California, 92124, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
Washington D.C., District of Columbia, 20010, United States
Research Site
Aventura, Florida, 33180, United States
Research Site
Clearwater, Florida, 33756, United States
Research Site
Jacksonville, Florida, 32204, United States
Research Site
Miami, Florida, 33145, United States
Research Site
Pembroke Pines, Florida, 33028, United States
Research Site
Weston, Florida, 33331, United States
Research Site
Atlanta, Georgia, 30322, United States
Research Site
Indianapolis, Indiana, 46202, United States
Research Site
Kenner, Louisiana, 70065, United States
Research Site
New Orleans, Louisiana, 70121, United States
Research Site
Detroit, Michigan, 48236, United States
Research Site
New York, New York, 10032, United States
Research Site
Morehead City, North Carolina, 28557, United States
Research Site
Columbus, Ohio, 43210-1296, United States
Research Site
Randwick, New South Wales, 2031, Australia
Research Site
St Leonards, New South Wales, 2065, Australia
Research Site
Footscray, Victoria, 3011, Australia
Research Site
Geelong, Victoria, 3220, Australia
Research Site
Nedlands, Western Australia, 6009, Australia
Research Site
Calgary, Alberta, T2N 4Z6, Canada
Research Site
London, Ontario, N6A 4V2, Canada
Research Site
Oakville, Ontario, L6J 1X8, Canada
Research Site
Toronto, Ontario, M5C 2T2, Canada
Research Site
Budapest, 1083, Hungary
Research Site
Budapest, 1088, Hungary
Research Site
Budapest, 1113, Hungary
Research Site
Szeged, 6720, Hungary
Research Site
Warsaw, 01-809, Poland
Research Site
Warsaw, 02-097, Poland
Research Site
Warsaw, 02-507, Poland
Research Site
Coimbra, 3000-075, Portugal
Research Site
Lisbon, 1350-179, Portugal
Research Site
Lisbon, 1649-035, Portugal
Research Site
Moscow, 117036, Russia
Research Site
Moscow, 119034, Russia
Research Site
Moscow, 129110, Russia
Research Site
Rostov-na-Dony, 344022, Russia
Research Site
Saint Petersburg, 197341, Russia
Research Site
Yaroslavl, 150003, Russia
Related Publications (1)
Khan A, Bilezikian J, Bone H, Gurevich A, Lakatos P, Misiorowski W, Rozhinskaya L, Trotman ML, Toth M. Cinacalcet normalizes serum calcium in a double-blind randomized, placebo-controlled study in patients with primary hyperparathyroidism with contraindications to surgery. Eur J Endocrinol. 2015 May;172(5):527-35. doi: 10.1530/EJE-14-0877. Epub 2015 Jan 30.
PMID: 25637076BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2009
First Posted
September 11, 2009
Study Start
March 10, 2010
Primary Completion
July 12, 2012
Study Completion
December 21, 2012
Last Updated
October 17, 2018
Results First Posted
January 25, 2016
Record last verified: 2018-09