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

NCT ID: NCT03052075

Last Updated: 2020-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-03

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Hyperparathyroidism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Retrospective Data Review

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nancy D. Perrier, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nancy D. Perrier, MD

Role: CONTACT

713-792-6940

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PA14-0401

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bone Health Observational Study
NCT00632905 COMPLETED