Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Amiloride; Cinacalcet; Cinacalcet Hydrochloride; Eplerenone; Spironolactone

Criteria

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.