Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Biomarker/Laboratory analysis, Diagnostic, Treatment	Closed	18 and over	NCI	SWOG-S0307A S0307A, NCT00873808

Objectives

1. 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.
2. 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.
3. 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.
4. 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).
5. 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.

Entry 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

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

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

Expected Enrollment

Outcomes

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

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

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Dawn Hershman, MD, Protocol chair		Ph: 212-305-1945

Related Information

PDQ® clinical trial SWOG-S0307

Registry Information
Official Title		Long-Term Bone Quality in Women with Breast Cancer (A Companion Study to S0307)
Trial Start Date		2008-10-01
Trial Completion Date		2012-02-01 (estimated)
Registered in ClinicalTrials.gov		NCT00873808
Date Submitted to PDQ		2008-09-03
Information Last Verified		2010-01-28
NCI Grant/Contract Number		CA32102

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