Short- and Long-Term Impact of Subtotal Parathyroidectomy on the Achievement of Bone and Mineral Parameters Recommended by Clinical Practice Guidelines in Dialysis Patients

NCT01872429 | Completed

• 1 other identifier: FEMH-IRB-102034-E
• Study Type: observational
• Target: 401
• Locations: 1 country
• Sites: 1

Brief Summary

The impact of parathyroidectomy (PTX) on the bone mineral parameters in dialysis patients with secondary hyperparathyroidism (SHPT) remains unclear. The investigators performed this study to present the short- and long-term impact of PTX on calcium, phosphorus and intact parathyroid hormone control in dialysis patients with severe SHPT after operation. In particular, the investigators evaluate the impact based on the achievement of recommendations of the current clinical practice guidelines for bone and mineral parameters in dialysis patients after PTX.

Conditions

Hyperparathyroidism

Keywords

subtotal parathyroidectomy; calcium; phosphorus; parathyroid hormone; hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• The percentages of cases achieving the recommended K/DOQI and KDIGO targets for bone mineral parameters after subtotal PTx

  Twelve year period after surgery

Study Arms (2)

Short-term group

Patients with postoperative 6-month laboratory data were included in the short-term group

Long-term group

Patients with postoperative more than 6-month laboratory data were included in the long-term group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dialysis patients, including referred cases, from the tertiary-care medical center in northern Taiwan.

You may qualify if:

• dialysis patients
• secondary hyperparathyroidism refractory to medical treatment
• patients receiving subtotal parathyroidectomy by one surgeon
• available laboratory data for at least six months after surgery

You may not qualify if:

• patients receiving parathyroidectomy other than subtotal type by other surgeon
• available laboratory data less than six months after surgery

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Hyperparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 7, 2013
• Study Start: November 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 7, 2013

Record last verified: 2013-04

Locations

TW (1)