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

Condition(s) targeted: Breast Cancer

Intervention: clodronate disodium (Drug); ibandronate sodium (Drug); zoledronic acid (Drug); laboratory biomarker analysis (Other); adjuvant therapy (Procedure); computed tomography (Procedure); dual x-ray absorptometry (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Southwest Oncology Group

Official(s) and/or principal investigator(s):
Dawn Hershman, MD, Study Chair, Affiliation: Herbert Irving Comprehensive Cancer Center

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.

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

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

Study design: Diagnostic, Open Label

Primary outcome: 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:

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

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 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 twice daily on days 1 and 2 and oral demeclocycline twice daily on days 11 and 12. Patients undergo a tetracycline-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 demeclocyline twice daily on days 1 and 2 and oral tetracycline twice daily on days 11 and 12. Patients undergo a demeclocycline-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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Big Sky Oncology, Great Falls, Montana 59405-5309, United States; Recruiting
Clinical Trail Office - Big Sky Oncology, Phone: 406-731-8217

Billings Clinic - Downtown, Billings, Montana 59107-7000, United States; Recruiting
Clinical Trials Office - Billings Clinic - Downtown, Phone: 800-996-2663, Email: research@billingsclinic.org

Bozeman Deaconess Cancer Center, Bozeman, Montana 59715, United States; Recruiting
Benjamin T. Marchello, MD, Phone: 406-238-6290

CCOP - Montana Cancer Consortium, Billings, Montana 59101, United States; Recruiting
Benjamin T. Marchello, MD, Phone: 406-238-6290

Community Medical Center, Missoula, Montana 59801, United States; Recruiting
Benjamin T. Marchello, MD, Phone: 406-238-6290

Glacier Oncology, PLLC, Kalispell, Montana 59901, United States; Recruiting
Benjamin T. Marchello, MD, Phone: 406-238-6290

Great Falls Clinic - Main Facility, Great Falls, Montana 59405, United States; Recruiting
Benjamin T. Marchello, MD, Phone: 406-238-6290

Guardian Oncology and Center for Wellness, Missoula, Montana 59804, United States; Recruiting
Benjamin T. Marchello, MD, Phone: 406-238-6290

Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana 59101, United States; Recruiting
Benjamin T. Marchello, MD, Phone: 406-238-6290

Kalispell Medical Oncology at KRMC, Kalispell, Montana 59901, United States; Recruiting
Benjamin T. Marchello, MD, Phone: 406-238-6290

Kalispell Regional Medical Center, Kalispell, Montana 59901, United States; Recruiting
Benjamin T. Marchello, MD, Phone: 406-238-6290

Great Falls, Montana 59405, United States; Recruiting
Benjamin T. Marchello, MD, Phone: 406-238-6290

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana 59807, United States; Recruiting
Clinical Trials Office - Montana Cancer Center at St. Patrick, Phone: 406-329-7029

Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana 59807-7877, United States; Recruiting
Clinical Trials Office - Montana Cancer Specialists at Montana, Phone: 406-238-6962

Northern Montana Hospital, Havre, Montana 59501, United States; Recruiting
Benjamin T. Marchello, MD, Phone: 406-238-6290

Northern Rockies Radiation Oncology Center, Billings, Montana 59101, United States; Recruiting
Benjamin T. Marchello, MD, Phone: 406-238-6290

Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana 59405, United States; Recruiting
Grant W. Harrer, MD, FACP, CCTI, Phone: 406-731-8100

St. James Healthcare Cancer Care, Butte, Montana 59701, United States; Recruiting
Benjamin T. Marchello, MD, Phone: 406-238-6290

St. Peter's Hospital, Helena, Montana 59601, United States; Recruiting
Benjamin T. Marchello, MD, Phone: 406-238-6290

St. Vincent Healthcare Cancer Care Services, Billings, Montana 59101, United States; Recruiting
Benjamin T. Marchello, MD, Phone: 406-238-6290

University Cancer Center at University of Washington Medical Center, Seattle, Washington 98195-6043, United States; Recruiting
Clinical Trials Office - University Cancer Center at Universit, Phone: 206-616-8289

Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming 82801, United States; Recruiting
Benjamin T. Marchello, MD, Phone: 406-238-6290

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: October 2008
Last updated: October 15, 2009