Parathyroidectomy in Endstage Renal Disease

NCT00745719 | Completed

• 1 other identifier: A111-102
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

To test the hypothesis that total parathyroidectomy retards cardiovascular calcification, improves bone mineral density, reduces cardiac hypertrophy and arterial stiffening in end-stage renal disease patients on maintenance dialysis.

Conditions

Endstage Renal Disease

Keywords

parathyroidectomy; cardiovascular; bone; endstage renal disease

Outcome Measures

Primary Outcomes (1)

• Change in vascular and valvular calcium scores

  12 months

Secondary Outcomes (12)

• Change in bone mineral density

  12 months

• change in aortic pulse wave velocity,

  12 months

• change in left ventricular mass, volume and function

  12 months

• changes in quality of life scores

  12 months

• changes in iPTH

  6 and 12 months

Study Arms (1)

1

EXPERIMENTAL

surgical total parathyroidectomy with forearm autografting

Procedure: parathyroidectomy

Interventions

parathyroidectomy PROCEDURE

total parathyroidectomy with forearm autografting

Also known as: total parathyroidectomy with forearm autografting

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Endstage renal disease patients receiving either long-term hemodialysis or peritoneal dialysis treatment, with elevated intact parathyroid hormone (iPTH) levels \> 500pg/ml on two or more occasions.
• Patients with parathyroid nodular or diffuse hyperplasia identified by ultrasound imaging or radioisotope scan.
• Patients who provide informed consent for the study.

You may not qualify if:

• Patients with significant background valvular heart disease
• Patients who are unfit for general anaesthesia
• Patients with acute myocardial infarction within recent two months
• Patients with poor general condition
• Patients with plans for living related kidney transplant within 1 year
• Patients with previous history of parathyroidectomy
• Patients with calciphylaxis
• Patients with underlying active malignancy
• Patients with contraindication for MRI

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital, Tung Wah Hospital

Hong Kong, 0000, Hong Kong

Location

MeSH Terms

Interventions

Parathyroidectomy

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Angela YM Wang, MD, PhD

  Queen Mary Hospital, University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Associate Professor

Model Details: Parathyroidectomy group versus natural disease control group

Study Record Dates

• First Submitted: September 1, 2008
• First Posted: September 3, 2008
• Study Start: March 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: January 1, 2012
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)