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Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00975221
Recruitment Status : Completed
First Posted : September 11, 2009
Results First Posted : January 25, 2016
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

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.

Condition or disease Intervention/treatment Phase
Hyperparathyroidism, Primary Hypercalcemia Drug: Cinacalcet Drug: Placebo Phase 3

Detailed Description:
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). Participants who complete 28 weeks on study will continue into an open-label safety extension phase for 24 weeks of investigational cinacalcet treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 10, 2010
Actual Primary Completion Date : July 12, 2012
Actual Study Completion Date : December 21, 2012


Arm Intervention/treatment
Experimental: Cinacalcet
Participants 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.
Drug: Cinacalcet
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).
Other Names:
  • Sensipar
  • Mimpara

Placebo Comparator: Placebo
Participants 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.
Drug: Cinacalcet
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).
Other Names:
  • Sensipar
  • Mimpara

Drug: Placebo
Administered orally following the same tiitration regimen as the experimental arm.




Primary Outcome Measures :
  1. Percentage of Participants With Mean Corrected Total Serum Calcium Concentration ≤ 10.3 mg/dL (2.57 mmol/L) During the EAP [ Time Frame: Efficacy assessment phase (study visits at Weeks 16, 20, 24, and 28) ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: Baseline and the EAP (mean of Weeks 16, 20, 24, and 28) ]
  2. Percent Change From Baseline in Corrected Total Serum Calcium Concentration During the EAP [ Time Frame: Baseline and the EAP (mean of Weeks 16, 20, 24, and 28) ]
  3. Percent Change From Baseline in Plasma Parathyroid Hormone Level During the EAP [ Time Frame: Baseline and the EAP (mean of Weeks 16, 20, 24, and 28) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥ 18 years
  • diagnosis of primary hyperparathyroidism (HPT)
  • subjects must have the following laboratory values:

    1. 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
    2. 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
  • before any study-specific procedure is performed, the appropriate written informed consent must be obtained

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975221


Locations
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United States, California
Research Site
Lake Forest, California, United States, 92630
Research Site
Lancaster, California, United States, 93534
Research Site
Los Gatos, California, United States, 95032
Research Site
Mission Viejo, California, United States, 92691
Research Site
Orange, California, United States, 92869
Research Site
San Diego, California, United States, 92124
United States, Colorado
Research Site
Aurora, Colorado, United States, 80045
United States, District of Columbia
Research Site
Washington, District of Columbia, United States, 20010
United States, Florida
Research Site
Aventura, Florida, United States, 33180
Research Site
Clearwater, Florida, United States, 33756
Research Site
Jacksonville, Florida, United States, 32204
Research Site
Miami, Florida, United States, 33145
Research Site
Pembroke Pines, Florida, United States, 33028
Research Site
Weston, Florida, United States, 33331
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30322
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Research Site
Kenner, Louisiana, United States, 70065
Research Site
New Orleans, Louisiana, United States, 70121
United States, Michigan
Research Site
Detroit, Michigan, United States, 48236
United States, New York
Research Site
New York, New York, United States, 10032
United States, North Carolina
Research Site
Morehead City, North Carolina, United States, 28557
United States, Ohio
Research Site
Columbus, Ohio, United States, 43210-1296
Australia, New South Wales
Research Site
Randwick, New South Wales, Australia, 2031
Research Site
St Leonards, New South Wales, Australia, 2065
Australia, Victoria
Research Site
Footscray, Victoria, Australia, 3011
Research Site
Geelong, Victoria, Australia, 3220
Australia, Western Australia
Research Site
Nedlands, Western Australia, Australia, 6009
Canada, Alberta
Research Site
Calgary, Alberta, Canada, T2N 4Z6
Canada, Ontario
Research Site
London, Ontario, Canada, N6A 4V2
Research Site
Oakville, Ontario, Canada, L6J 1X8
Research Site
Toronto, Ontario, Canada, M5C 2T2
Hungary
Research Site
Budapest, Hungary, 1083
Research Site
Budapest, Hungary, 1088
Research Site
Budapest, Hungary, 1113
Research Site
Szeged, Hungary, 6720
Poland
Research Site
Warszawa, Poland, 01-809
Research Site
Warszawa, Poland, 02-097
Research Site
Warszawa, Poland, 02-507
Portugal
Research Site
Coimbra, Portugal, 3000-075
Research Site
Lisboa, Portugal, 1350-179
Research Site
Lisboa, Portugal, 1649-035
Russian Federation
Research Site
Moscow, Russian Federation, 117036
Research Site
Moscow, Russian Federation, 119034
Research Site
Moscow, Russian Federation, 129110
Research Site
Rostov-na-Dony, Russian Federation, 344022
Research Site
Saint Petersburg, Russian Federation, 197341
Research Site
Yaroslavl, Russian Federation, 150003
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
Publications:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00975221    
Other Study ID Numbers: 20070277
First Posted: September 11, 2009    Key Record Dates
Results First Posted: January 25, 2016
Last Update Posted: October 17, 2018
Last Verified: September 2018
Keywords provided by Amgen:
Primary hyperparathyroidism
Parathyroidectomy
Hypercalcemia
Additional relevant MeSH terms:
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Hypercalcemia
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Cinacalcet
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists