S0307A, Long-Term Bone Quality in Women With Breast Cancer Enrolled on Clinical Trial SWOG-S0307

April 9, 2013 updated by: Southwest Oncology Group

Long-Term Bone Quality in Women With Breast Cancer (A Companion Study to S0307)

RATIONALE: Gathering information over time from imaging and laboratory tests of women receiving bisphosphonates for breast cancer may help doctors learn more about long-term bone quality and plan the best treatment. Tetracycline hydrochloride and demeclocycline hydrochloride can mark the new growth of the bone, so it may be seen better under a microscope.

PURPOSE: This clinical trial is studying long-term bone quality in women with breast cancer enrolled on clinical trial SWOG-S0307.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To assess if long-term high-dose bisphosphonates alter bone quality as measured by change in the histomorphometry of bone biopsies after tetracycline hydrochloride labeling to calculate eroded and osteoid surfaces, mineralization surface, bone formation rate, wall width, and activation frequency.
  • To assess if long-term high-dose bisphosphonates alter bone quality as measured by change in the backscattered electron imaging of bone to measure average mineralization density as well as distribution of density values.
  • To assess if long-term high-dose bisphosphonates alter bone quality as measured by change in the micro-computed tomography of bone biopsy specimens to measure bone structure, including bone volume, connectivity, trabecular width, and cortical width.
  • To assess if long-term high-dose bisphosphonates alter bone quality as measured by change in the biomechanical testing of bone biopsy samples loaded in compression to measure stress-strain relationships, including Young's modulus, yield point, ultimate strain, and work to failure (toughness).
  • To characterize bone using classical, non-invasive techniques (i.e., measurement of bone mineral density of spine and hip using dual energy x-ray absorptiometry and analysis of serum biochemical markers of bone formation [i.e., bone specific alkaline phosphatase] and resorption [i.e., N-telopeptide]) after long-term, high-dose bisphosphonates.

OUTLINE: This is a multicenter study.

At baseline (prior to initiating bisphosphonate therapy on SWOG-S0307), patients receive oral tetracycline hydrochloride twice daily on days 1 and 2 and oral demeclocycline hydrochloride twice daily on days 11 and 12. Patients undergo a tetracycline hydrochloride-labeled bone biopsy from the anterior ilium on day 14. At 36 months (for patients who have completed bisphosphonate therapy) or after 30 months of concurrent bisphosphonate therapy, patients receive oral demeclocycline twice daily on days 1 and 2 and oral tetracycline hydrochloride twice daily on days 11 and 12. Patients undergo a demeclocycline hydrochloride-labeled bone biopsy from the anterior ilium on day 14.

Patients undergo dual energy x-ray absorptiometry measurements of the hip and spine at the time of biopsy or within the next 10 weeks. Blood samples are collected for analysis of bone specific alkaline phosphatase and N-telopeptide before and after treatment on the clinical trial.

After completion of study treatment, patients are followed for up to 10 years.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195-6043
        • University Cancer Center at University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Concurrently enrolled on clinical trial SWOG-S0307 and receiving bisphosphonates as adjuvant therapy for primary breast cancer
  • No rickets, osteogenesis imperfecta, osteosclerosis, or osteomalacia
  • No bone fracture since the age of 21 years unless it was caused by trauma
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • Weight < 300 lbs
  • No hyperparathyroidism
  • No serious concurrent or prior anorexia nervosa diagnosed by a physician and causing abnormal menstruation
  • No history of hypersensitivity to tetracycline or demeclocycline

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 10 years since prior prednisone at a dose above 5 mg/day for ≥ 3 months
  • No prior prednisone before diagnosis of breast cancer
  • No prior bisphosphonate therapy
  • No concurrent anticonvulsant medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in bone quality after long-term high-dose bisphosphonates as measured by histomorphometry, mineralization density, micro-computed tomography, and biomechanics of bone biopsy samples

Secondary Outcome Measures

Outcome Measure
Comparison of the potency of bisphosphonates as measured by changes in bone quality in each treatment group
Correlations among measures of bone formation, structure, mineralization, and strength

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

April 1, 2009

First Submitted That Met QC Criteria

April 1, 2009

First Posted (Estimate)

April 2, 2009

Study Record Updates

Last Update Posted (Estimate)

April 10, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000614118
  • U10CA032102 (U.S. NIH Grant/Contract)
  • S0307A (Other Identifier: SWOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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