Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03052075
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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
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.

Layout table for study information
Study Type : Observational
Estimated 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 : September 3, 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020


Group/Cohort 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).




Primary Outcome Measures :
  1. Percent Change in Bone Mineral Density [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052075


Contacts
Layout table for location contacts
Contact: Nancy D. Perrier, MD 713-792-6940

Locations
Layout table for location information
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Nancy D. Perrier, MD M.D. Anderson Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03052075     History of Changes
Other Study ID Numbers: PA14-0401
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Primary Hyperparathyroidism
Parathyroidectomy
Bone mineral density
BMD
Data Review

Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases