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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

N/A

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

Safety Issue:

No

Principal Investigator

Dawn Hershman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000614118

NCT ID:

NCT00873808

Start Date:

October 2008

Completion Date:

February 2010

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195