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

NCT02216721 | Completed DMC

• 1 other identifier: FF-2014-267
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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 of secondary hypertension. Early detection is important to avoid end organ damage, specifically cardiovascular and metabolic morbidity. Recent studies showed a positive correlation between patients with PA with lower bone density especially at the spine, with significant improvement post treatment, either medically or surgically. There was also a positive correlation between high aldosterone renin ratio with higher levels of intact parathyroid hormone (iPTH) which is responsible for cortical bone loss especially at the distal forearm. We hypothesize that our patients with PA have a higher level of iPTH, with lower bone density especially at the distal forearm, with improvement post treatment.

Conditions

Primary Aldosteronism

Keywords

bone mineral density; bone turnover markers; primary aldosteronism treatment

Outcome Measures

Primary Outcomes (1)

• Bone mineral density

  Change of bone mineral density 3 months post treatment for primary aldosteronism

  3 months

Secondary Outcomes (1)

• Bone turnover markers

  3 months

Study Arms (2)

Non primary aldosteronism

Non primary aldosteronism patients undergoing usual anti hypertensive treatment

Primary Aldosteronism

Patients with confirmed primary aldosteronism undergoing treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective study conducted in out-patient clinics of a tertiary care center. The study population consists of patients referred to our centres for endocrine hypertension.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Malaysia Sarawak: lead

Study Sites (1)

Hospital Universiti Kebangsaan Malaysia

Kuala Lumpur, WP Kuala Lumpur, 56000, Malaysia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 15, 2014
• Study Start: August 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

MY (1)