Clinical trial · Observational
S0307A, Long-Term Bone Quality in Women With Breast Cancer Enrolled on Clinical Trial SWOG-S0307
Long-Term Bone Quality in Women With Breast Cancer (A Companion Study to S0307)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| clodronate disodium | Drug | — | UNRESOLVED |
| computed tomography | Procedure | — | UNRESOLVED |
| demeclocycline hydrochloride | Drug | — | UNRESOLVED |
| dual x-ray absorptiometry | Procedure | — | UNRESOLVED |
| ibandronate sodium | Drug | Ibandronic Acid | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| tetracycline hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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 outcomes (2)
- measure
- Comparison of the potency of bisphosphonates as measured by changes in bone quality in each treatment group
- measure
- Correlations among measures of bone formation, structure, mineralization, and strength
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available