Screening of Bone Mineral Density in Women Who Have Received Chemotherapy

NCT00603551 | Completed

• 4 other identifiers: HR # 16417Wyeth Protocol # 0713X-102016GCRC Protocol # 744HCC CTO # 101019
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Density; Cancer

Keywords

Osteoporosis; Cancer; Chemotherapy; Bone Density; DXA Scan; Heel Scan

Outcome Measures

Primary Outcomes (1)

• The Z-score of the DXA scan compared to age-matched controls

  Once, at enrollment

Secondary Outcomes (1)

• The T-score of the Heel Scan compared to the T score of the DXA Scan

  Once, at enrollment

Study Arms (1)

Chemotherapy

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Postmenopausal woman
• Diagnosed with breast or gynecological cancer
• Treated with chemotherapy

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Neoplasms; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• William Creasman, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: January 29, 2008
• Study Start: November 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 19, 2018

Record last verified: 2008-07

Locations

US (1)