Recruiting

Parathyroidectomy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03052075

Conditions

Primary Hyperparathyroidism

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Retrospective Data Review

Study Details

Brief summary:

The primary objective of this study is to estimate the percent change in baseline bone mineral density (BMD) starting at one year after parathyroidectomy and all the following available dates in patients presenting with primary hyperparathyroidism. The secondary objective is to identify patient factors associated with change in BMD.

Conditions

Primary Hyperparathyroidism

Study ID

NCT03052075

Start date

Sep 3, 2014

Status verified date

Jan, 2020

Completion date

Sep 30, 2020

Anticipated

Primary completion date

Sep 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. The patient cohort for this study consists of all patients within the prospectively maintained parathyroid database within the Department of Surgical Oncology at the University of Texas MD Anderson Cancer Center.
2. Patients with a diagnosis of primary hyperparathyroidism who underwent parathyroidectomy during the period of September 27, 1990 to December 31, 2013 were considered.
3. All patients who had a preoperative and one year post-operative DEXA study over the time period will be included.

Exclusion Criteria:

N/A

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Parathyroidectomy Data Review

The research plan is for a retrospective review to be performed of a prospectively maintained parathyroid database within the Department of Surgical Oncology at the University of Texas MD Anderson Cancer Center.

Interventions

Retrospective Data Review

Retrospective, uncontrolled pre- and post-test design in a case series of approximately 250 patients who underwent parathyroidectomy at MD Anderson Cancer Center (years 1990 - 2013 ) and had bone density measures recorded at baseline and at one year post-surgery. Data extracted from the surgical oncology database for bone mineral density measures for each patient at multiple sites including the lumbar spine, total hip (right/left), femoral neck (right/left), and distal 1/3 radius. All measures recorded from two time points: presurgical (baseline) and postsurgical (all follow-up available dates beginning at 1 year post-parathyroidectomy).

Primary outcome measure

  • Percent Change in Bone Mineral Density [ Time Frame: Baseline to at least one year after parathyroidectomy ]

Central Contacts and Locations

Central contacts

Nancy D. Perrier, MD

713-792-6940NPerrier@mdanderson.org

Locations

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jan 10, 2020

Last verified

Jan, 2020

Keywords

  • Primary Hyperparathyroidism
  • Parathyroidectomy
  • Bone mineral density
  • BMD
  • Data Review

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2020-01-10.