Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism

107407

This study will evaluate whether blocking the mineralocorticoid receptor, alone, or in combination with the calcimimetic cinacalcet, can lower parathyroid hormone and calcium levels in primary hyperparathyroidism.

2016-01-01

2021-10-01

2021-10-02

Completed

Early phase I

69

Inclusion Criteria: * physician diagnosis of active P-HPTH (Serum calcium \> upper limit of reference range and serum PTH \> ULRR; or Serum Calcium \> ULRR AND serum PTH \> 30 pg/mL; or Serum Calcium within 0.2 mg/dL of the ULRR and PTH\>ULRR). * negative pregnancy test in women aged 18-45 Exclusion Criteria: * estimated glomerular filtration rate \< 60mL/min/1,73m2 * serum potassium \> 5.0 mmol/L * age \<18 or \>80 years * diabetes that is not well controlled (HbA1c\>8%)\\ * liver failure * heart failure * history of myocardial infarction or stroke * active use of lithium * active chronic inflammatory conditions (such as inflammatory bowel disease, rheumatoid arthritis, sarcoidosis) * initiation within 3 months of bisphosphonates or cinacalcet * need for imminent parathyroidectomy (within the next 6-8 weeks) as determined by their endocrinologist or surgeon * absolute serum calcium \>13.0 mg/dL * positive pregnancy test on any of the study visits for women ages 18-45.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3-parallel-armed double-blinded randomized controlled trial wherein monotherapy of eplerenone or amiloride or placebo administered for 4 weeks. After weeks, an open-label extension addition of cinacalcet to all 3 arms conducted for 2 weeks.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 69, 'type': 'ACTUAL'}}

2023-05-03