Effect of Aromatase Inhibitors on Bones and Genes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00603967
First received: January 4, 2008
Last updated: May 22, 2013
Last verified: May 2013
  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
Procedure: Dual x-ray absorptiometry (DXA)
Procedure: Blood draw
Behavioral: Questionnaire

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Aromatase Inhibitors: Skeletal Effects and the Role of CYP19 Gene Polymorphisms

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Skeletal effects of aromatase inhibitors in postmenopausal women with estrogen receptor positive breast cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Influence of polymorphisms of the CYP19 gene on the skeletal response to aromatase inhibitors. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Influence of the CYP19 gene polymorphisms on the menopausal symptoms in women on aromatase inhibitor therapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 151
Study Start Date: March 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Aromatase inhibitor Procedure: Dual x-ray absorptiometry (DXA)
Baseline, 6 months, and 12 months
Procedure: Blood draw
Baseline - genotyping Baseline, 6 months, and 12 months - markers of bone turnover and hormonal assays
Behavioral: Questionnaire

Menopausal symptom questionnaire - baseline, 3 months, 6 months, 12 months

Cognitive tests - baseline, 6 months, 12 months

Depression assessment - baseline, 6 months, 12 months

Dietary calcium intake questionnaire - baseline


  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Antonella Rastelli, MD Washington University School of Medicine
  More Information

Publications:
Osborne,C.K. 1998. Tamoxifen in the treatment of breast cancer. N.Engl.J.Med. 339:1609-1618.

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00603967     History of Changes
Other Study ID Numbers: 05-0918, Grant
Study First Received: January 4, 2008
Last Updated: May 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Breast Cancer
Postmenopausal
Aromatase

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014