Effects of the mineralocorticoid-receptor blocker eplerenone on parathyroid hormone levels in patients with parathyroid hormone excess

Conditions: Primary hyperparathyroidism
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2011-005683-21-AT

Lead Sponsor: Medizinische Universität Graz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• Written informed consent
• Patients with primary hyperparathyroidism (PHPT) (diagnostic workup of patients with PHPT will be performed according to the 2008 Guidelines (stated in chapters 2.1.4 and 2.1.5) before enrollment into the EPATH Study and after thorough exclusion of other causes of elevated PTH and hypercalcemia):
- asymptomatic PHPT who do not meet guidelines for surgical treatment (according to the 2008 Guidelines published by Bilezikian et al. J Clin Endocrinol Metab 2009; 94(2):335-339.)
- symptomatic PHPT in whom surgery is recommended, but not
performed because of patient and/or physician preference or perceived
medical contraindications
• Age = 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

•25(OH)D levels < 20 ng/dl (50 nmol/liter)
•Estimated glomerular filtration rate (GFR; according to the MDRD formula) = 50 ml/min
•Serum potassium > 5.0 mEq/L (mmol/L) at baseline or > 5.5 mEq/L (mmol/L) during active study period
•Pregnancy or lactating women
•Drug intake as part of another clinical study 4 weeks before enrolment into the EPATH study and/or during the active study periode
•Any disease with an estimated life expectancy below 1 year
•Chemotherapy or radiation therapy during the study
•Intolerance to eplerenone or any ingredient occurring in eplerenone
•Severe acute or chronic liver diseases (Child-Pugh Class C)
•Concurrent intake of potassium sparing drugs, e.g. diuretics (amiloride and triamterene) or CPY3A4-inhibitors and ongoing potassium supplementation