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Effect of Aromatase Inhibitors on Bones and Genes

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ClinicalTrials.gov Identifier: NCT00603967
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : May 24, 2013
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Postmenopausal Procedure: Dual x-ray absorptiometry (DXA) Procedure: Blood draw Behavioral: Questionnaire Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Aromatase Inhibitors: Skeletal Effects and the Role of CYP19 Gene Polymorphisms
Study Start Date : March 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Skeletal effects of aromatase inhibitors in postmenopausal women with estrogen receptor positive breast cancer. [ Time Frame: 2 years ]
  2. Influence of polymorphisms of the CYP19 gene on the skeletal response to aromatase inhibitors. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Influence of the CYP19 gene polymorphisms on the menopausal symptoms in women on aromatase inhibitor therapy. [ Time Frame: 2 years ]


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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes 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.

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): 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

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00603967     History of Changes
Other Study ID Numbers: 05-0918
Grant
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: May 24, 2013
Last Verified: May 2013

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

Additional relevant MeSH terms:
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs