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Screening of Bone Mineral Density in Women Who Have Received Chemotherapy

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ClinicalTrials.gov Identifier: NCT00603551
Recruitment Status : Unknown
Verified July 2008 by Medical University of South Carolina.
Recruitment status was:  Recruiting
First Posted : January 29, 2008
Last Update Posted : July 21, 2008
Information provided by:

Study Description
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.

Condition or disease
Bone Density Cancer

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 Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Screening of Bone Mineral Density in Women Who Have Received Chemotherapy
Study Start Date : November 2006
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Postmenopausal women who have been diagnosed with a breast or gynecological cancer and who have undergone chemotherapy as a result of that diagnosis

Outcome Measures

Primary Outcome Measures :
  1. The Z-score of the DXA scan compared to age-matched controls [ Time Frame: Once, at enrollment ]

Secondary Outcome Measures :
  1. The T-score of the Heel Scan compared to the T score of the DXA Scan [ Time Frame: Once, at enrollment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

  • Postmenopausal woman
  • Diagnosed with breast or gynecological cancer
  • Treated with chemotherapy
Contacts and Locations

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): NCT00603551

Contact: William Creasman, MD 8437920634 creasman@musc.edu
Contact: Dene Wrenn, MD 8437924500 wrennd@musc.edu

United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Wyeth is now a wholly owned subsidiary of Pfizer
National Center for Research Resources (NCRR)
Principal Investigator: William Creasman, MD Medical University of South Carolina
More Information

Responsible Party: William Creasman, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00603551     History of Changes
Other Study ID Numbers: HR # 16417
Wyeth Protocol # 0713X-102016
GCRC Protocol # 744
HCC CTO # 101019
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: July 21, 2008
Last Verified: July 2008

Keywords provided by Medical University of South Carolina:
Bone Density
DXA Scan
Heel Scan