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

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