Effect of Aromatase Inhibitors on Bones and Genes - Full Text View

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00603967

Sponsored by:

Washington University School of Medicine

Information provided by:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT00603967

Purpose

The primary objective of this 2-year pilot project is to test the hypothesis that skeletal response to aromatase inhibitors is determined by polymorphisms of the CYP19 gene.

Condition	Intervention
Breast Cancer Postmenopausal	Drug: Aromatase Inhibitors (Either Arimidex, Femara or Aromasin) Genetic: Blood draw

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole Letrozole Exemestane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Aromatase Inhibitors: Skeletal Effects and the Role of CYP19 Gene Polymorphisms

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Bone density changes and menopausal scores correlated with polymorphisms as predictors. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	210
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Per treating physician.

Blood draw for aromatase gene polymorphism studies.

Show Detailed Description

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal women aged greater than or equal to 40 years, at least 12 months from last menstrual period. For subjects who are amenorrheic for < 12 months (including patients who had hysterectomy, received ERT/HRT, or rendered amenorrheic by chemotherapy), they must have serum FSH ≥50 UI/L.
Must have diagnosis of breast cancer stages I-IIIA.
Planned therapy for the treatment group must include aromatase inhibitors using third generation non-steroidal aromatase inhibitors, anastrozole or letrozole. Those who are already treated with aromatase inhibitors and have bone density measurements prior to initiation of aromatase inhibitors or will be switched from tamoxifen to third generation aromatase inhibitors will also be included in the study.
Bone mineral density measurement must range from normal to osteopenia (T-scores between +2.0/-2.0). Those with T-scores of <-2.0 in either the lumbar spine or the femoral neck as well as those with a history of osteoporosis-related fractures or vertebral deformities on lateral spine radiographs will be excluded from the study.
Must be ambulatory willing and able to provide informed consent.

Exclusion Criteria:

No current use of medications affecting bone metabolism, namely: estrogen, raloxifene, tamoxifen, bisphosphonates, GnRH analogues, glucocorticoids of at least 5 mg daily for 1 month or more, anabolic steroids and dilantin.
No evidence of diseases known to interfere with bone metabolism, such as hyperparathyroidism, hyperthyroidism, osteomalacia, chronic liver disease, renal failure, hypercortisolism, malabsorption, and immobilization.
No current alcohol or tobacco abuse.
No evidence of bone metastasis or evidence of abnormal clinical laboratory parameters that are assessed as clinically significant by the investigator.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603967

Contacts

Contact: Reina Villareal, MD	314-454-7987	rvillare@im.wustl.edu
Contact: Jayasree Yarramaneni, MD	314-454-8437	JYARRAMA@im.wustl.edu

Locations

United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jayasree Yarramaneni, MD 314-454-8437 jyarrama@im.wustl.edu
Contact: Kirsten E Cady, BS 314-362-7773 cadyk@ccadmin.wustl.edu
Principal Investigator: Reina Villareal, MD
Sub-Investigator: Jayasree Yarramaneni, MD
Sub-Investigator: Antonella Rastelli, MD
Sub-Investigator: Matthew Ellis, MB, PhD
Sub-Investigator: Michael Naughton, MD
Sub-Investigator: Rama Suresh, MD
Sub-Investigator: Katherine Weilbaecher, MD
Sub-Investigator: Marie Taylor, MD

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Reina Villareal, MD

Washington University School of Medicine

Responsible Party:	Washington University School of Medicine ( Reina Villareal, MD )
Study ID Numbers:	05-0918, Grant
Study First Received:	January 4, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00603967
Health Authority:	United States: Institutional Review Board