Screening of Bone Mineral Density in Women Who Have Received Chemotherapy

NCT00603551

Last updated date
Study Location
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bone Density, Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Postmenopausal woman

- Diagnosed with breast or gynecological cancer

- Treated with chemotherapy

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Bone Density, CancerScreening of Bone Mineral Density in Women Who Have Received Chemotherapy
NCT00603551
  1. Charleston, South Carolina
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Screening of Bone Mineral Density in Women Who Have Received Chemotherapy
Official Title Screening of Bone Mineral Density in Women Who Have Received Chemotherapy
Brief Summary The hypothesis is that postmenopausal women who have received chemotherapy have a greater bone loss than the same age controls. The aim of this study is to obtain baseline bone mineral density (BMD) data on women with breast and gynecological cancers who have received chemotherapy. By comparing the Z scores of postmenopausal women who have received chemotherapy with age matched controls this hypothesis can be evaluated. Another goal of the study is to compare the T-score of a Heel Bone Density Scan to the T-score of the DXA Scan to see if there is a good correlation between peripheral and DXA scores.
Detailed Description

It is generally accepted that women who develop breast cancer have an increased bone mineral density (BMD) probably due to endogenous estrogen production. After menopause, BMD decreases rather rapidly particularly during the first years after natural menopause. Bone loss typically is more rapid and severe in a premature induced menopause (surgical, chemotherapeutically, or hormonal). The bone loss appears to be more rapid and at an earlier age which advances bone age to a greater degree than actual age. Chemotherapeutically-induced menopause accelerates this process by an average of 10 years. GnRH agonist in premenopausal women causes amenorrhea in >95% with associated loss of both cortical and trabecular bone. In women undergoing ovarian ablation therapy, losses in bone mass as high as 13% have been reported in the first year of treatment. Premenopausal women who by treatment become amenorrheic remain amenorrheic posttreatment in the vast majority of cases. Adjuvant therapy for cancer can exaggerate bone mineral density loss. Chemotherapy may have an effect on estrogen levels but may also have an effect on bone loss via direct cytotoxic effect on bone cells.

Although there is data concerning BMD in patients who have received chemotherapy as children and in men with prostate cancer, there is very little data concerning BMD in gynecologic oncology patients who have received chemotherapy. Several different chemotherapeutic agents have been incriminated in their effects on the bone mineral density. The alkylating drugs, particularly Cytoxan, have been shown to decrease bone mineral density. Methotrexate and more recently the taxanes appear to have the same effect. Since most chemotherapy today is given as a combination, one or more of the cytoxic agents on the bone are included and therefore this study will evaluate any postmenopausal women who has received chemotherapy.

Data collection:

Women participating in this study will undergo two scans: a Heel Scan which measures the bone mineral density in the heel area and a DXA scan which measures bone mineral density in the lumbar region of the spine and the hip. Both scans provide a T-score and a Z-score for the subject.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population consists of postmenopausal women with breast or gynecological cancers who were treated with chemotherapy. The subjects either received their chemotherapy or follow-up at the Hollings Cancer Center at the Medical University of South Carolina.
Condition
  • Bone Density
  • Cancer
Intervention Not Provided
Study Groups/Cohorts Chemotherapy
Postmenopausal women who have been diagnosed with a breast or gynecological cancer and who have undergone chemotherapy as a result of that diagnosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 18, 2018)
106
Original Estimated Enrollment
 (submitted: January 28, 2008)
100
Actual Study Completion Date December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Postmenopausal woman
  • Diagnosed with breast or gynecological cancer
  • Treated with chemotherapy
Sex/Gender
Sexes Eligible for Study:Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00603551
Other Study ID Numbers HR # 16417
Wyeth Protocol # 0713X-102016
GCRC Protocol # 744
HCC CTO # 101019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party William Creasman, MD, Medical University of South Carolina
Study Sponsor Medical University of South Carolina
Collaborators
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • National Center for Research Resources (NCRR)
Investigators
Principal Investigator:William Creasman, MDMedical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date July 2008