Effects of eplerenone in patients with primary hyperparathyroidism

Phase 3

Completed

Conditions: Primary hyperparathyroidism (PHPT)
Nutritional, Metabolic, Endocrine
Primary hyperparathyroidism

Registration Number: ISRCTN33941607

Lead Sponsor: Medical University of Graz (Austria)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 110

Inclusion Criteria

1. Written informed consent
2. Patients with PHPT:
2.1. Asymptomatic PHPT who do not meet guidelines for surgical treatment
2.2. Symptomatic PHPT in whom surgery is recommended, but not performed because of patient and/or physician preference or perceived medical contraindications
3. Age = 18 years

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change of iPTH(1-84) levels from baseline after 8 weeks

Secondary Outcome Measures

Name	Time	Method
1. Mean change of 24-hour systolic and diastolic ambulatory BP levels from baseline after 8 weeks<br>2. Mean change of NT-pro-BNP and osteoprotegerin from baseline after 8 weeks<br>3. Mean change of biomarkers of bone metabolism: osteocalcin, ß-CrossLaps, bone alkaline phosphatase