Screening of Bone Mineral Density in Women Who Have Received Chemotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Medical University of South Carolina.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00603551
First received: January 17, 2008
Last updated: July 18, 2008
Last verified: July 2008

January 17, 2008
July 18, 2008
November 2006
November 2008   (final data collection date for primary outcome measure)
The Z-score of the DXA scan compared to age-matched controls [ Time Frame: Once, at enrollment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00603551 on ClinicalTrials.gov Archive Site
The T-score of the Heel Scan compared to the T score of the DXA Scan [ Time Frame: Once, at enrollment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Screening of Bone Mineral Density in Women Who Have Received Chemotherapy
Screening of Bone Mineral Density in Women Who Have Received Chemotherapy

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Probability Sample

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.

  • Bone Density
  • Cancer
Not Provided
Chemotherapy
Postmenopausal women who have been diagnosed with a breast or gynecological cancer and who have undergone chemotherapy as a result of that diagnosis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Postmenopausal woman
  • Diagnosed with breast or gynecological cancer
  • Treated with chemotherapy
Female
18 Years and older
No
Contact: William Creasman, MD 8437920634 creasman@musc.edu
Contact: Dene Wrenn, MD 8437924500 wrennd@musc.edu
United States
 
NCT00603551
HR # 16417, Wyeth Protocol # 0713X-102016, GCRC Protocol # 744, HCC CTO # 101019
No
William Creasman, MD, Medical University of South Carolina
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
Medical University of South Carolina
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP