Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy
Hyperparathyroidism, Primary, Hypercalcemia
About this trial
This is an interventional treatment trial for Hyperparathyroidism, Primary focused on measuring Primary hyperparathyroidism, Parathyroidectomy, Hypercalcemia
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Cinacalcet
Placebo
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.
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.