Phase 3 N=41 Randomized Quadruple-blind Treatment

Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism

Primary Hyperparathyroidism

Bottom Line

View on ClinicalTrials.gov: NCT02525796 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2023

Primary outcome: Primary: Change in Parathyroid Hormone Levels — 4.0; -3.7; 0.8 pg/mL — p=0.84

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: eplerenone (Drug); amiloride (Drug); Placebo (Drug); Cinacalcet (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: Oct 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Parathyroid Hormone Levels	4.0; -3.7; 0.8	0.84
SECONDARY Change in Calcium Levels	0.1; 0.0; 0.1	0.82

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.

Eligibility 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 5.0 mmol/L
age 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02525796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.