The Effect of Disease-specific Treatment on Bone Turnover Markers in Patients With Primary Aldosteronism

• Register: ClinicalTrials.gov
• Last refreshed on: 14 December 2015
• Main ID: NCT02216721
• Date of registration: 12/08/2014
• Prospective Registration: No
• Primary sponsor: University Malaysia Sarawak
• Public title: The Effect of Disease-specific Treatment on Bone Turnover Markers in Patients With Primary Aldosteronism
• Scientific title: The Effect of Disease-specific Treatment on Bone Turnover Markers in Patients With Primary Aldosteronism
• Date of first enrolment: August 2014
• Target sample size: 35
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02216721
• Study type: Observational
• Study design: Observational Model: Case Control, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Malaysia

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age >18 years old

2. 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

1. Patients on medication affecting bone metabolism, eg bisphosphonates, hormonal
replacement therapy, SERM, testosterone, antiandrogen, anticonvulsants, calcium and
Vitamin D

2. Primary aldosteronism post treatment (surgically or medically on spironolactone or
eplerenone)

3. Estimated GFR <30ml/min

4. Severe hepatic failure

5. Severe heart failure



Age minimum: 18 Years
Age maximum: 100 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Primary Aldosteronism

Primary Outcome(s)

Bone mineral density [Time Frame: 3 months]

Secondary Outcome(s)

Bone turnover markers [Time Frame: 3 months]

Secondary ID(s)

FF-2014-267

Source(s) of Monetary Support

Please refer to primary and secondary sponsors