Status:
COMPLETED
The Effect of Disease-specific Treatment on Bone Turnover Markers in Patients With Primary Aldosteronism
Lead Sponsor:
University Malaysia Sarawak
Conditions:
Primary Aldosteronism
Eligibility:
All Genders
18-100 years
Brief Summary
Primary aldosteronism (PA) is a disorder of the adrenal gland causing an autonomous overproduction of mineralocorticoids, leading to arterial hypertension. Although rare, it is the most frequent cause...
Detailed Description
In 2004, through an animal model study, rats given aldosterone/salt treatment were found to have reduction in bone mineral density (BMD) and cortical bone strength. This was believed to be due to hype...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age \>18 years old
- Confirmed primary aldosteronism with following criteria i) Aldosterone-renin ratio \> 555 SI or 30 (if aldosterone is taken in pmol/L, renin in ng/dL) and ii) Aldosterone post fludrocortisone suppression test \> 166pmol/L or \>6ng/dL, or iii) Aldosterone post saline suppression test \>277pmol/L or \>10ng/dL
- Exclusion Criteria
- Patients on medication affecting bone metabolism, eg bisphosphonates, hormonal replacement therapy, SERM, testosterone, antiandrogen, anticonvulsants, calcium and Vitamin D
- Primary aldosteronism post treatment (surgically or medically on spironolactone or eplerenone)
- Estimated GFR \<30ml/min
- Severe hepatic failure
- Severe heart failure
Exclusion
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT02216721
Start Date
August 1 2014
End Date
May 1 2015
Last Update
December 2 2015
Active Locations (1)
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1
Hospital Universiti Kebangsaan Malaysia
Kuala Lumpur, WP Kuala Lumpur, Malaysia, 56000