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

NCT03052075 | Unknown

• 1 other identifier: PA14-0401
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent Change in Bone Mineral Density

  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.

  Baseline to at least one year after parathyroidectomy

Study Arms (1)

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

Interventions

Retrospective Data Review OTHER

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).

Parathyroidectomy Data Review

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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 at MD Anderson Cancer Center.

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Nancy D. Perrier, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy D. Perrier, MD

CONTACT

713-792-6940; NPerrier@mdanderson.org

Study Design

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

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 14, 2017
• Study Start: September 3, 2014
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: January 10, 2020

Record last verified: 2020-01

Locations

US (1)