Percent Change in Baseline Bone Mineral Density (BMD) After Parathyroidectomy in Patients With Primary Hyperparathyroidism

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT03052075

Collaborator

(none)

250

Enrollment

Location

72.9

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Hyperparathyroidism	Other: Retrospective Data Review

Detailed Description

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. The patient cohort for this study consists of all patients with primary hyperparathyroidism who underwent parathyroidectomy and also had pre- and post-operative DEXA studies performed. The database will be reviewed to obtain patient and disease characteristics, laboratory values, DEXA imaging results, and surgical outcomes.

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Percent Change in Baseline Bone Mineral Density (BMD) After Parathyroidectomy in Patients With Primary Hyperparathyroidism

Actual Study Start Date :

Sep 3, 2014

Anticipated Primary Completion Date :

Sep 30, 2020

Anticipated Study Completion Date :

Sep 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: 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).

Arm

Intervention/Treatment

Parathyroidectomy Data Review

Other: 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).

Outcome Measures

Primary Outcome Measures

Percent Change in Bone Mineral Density [Baseline to at least one year after parathyroidectomy]
Data from the pre- and post-tests plotted and correlations assessed using the Pearson or Spearman rank correlation coefficient. Differences in pre- and post-operative bone mineral density measures at each site tested using a paired t-test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
Patients with a diagnosis of primary hyperparathyroidism who underwent parathyroidectomy during the period of September 27, 1990 to December 31, 2013 were considered.
All patients who had a preoperative and one year post-operative DEXA study over the time period will be included.