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Brief Title: Bone Density and Bone Loss in Postmenopausal Women With Breast Cancer Receiving Treatment in Clinical Trial IBCSG-1-98
Official Title: Investigating Bone Density and Bone Loss Without Baseline Information
Study ID: NCT00369850
Brief Summary: RATIONALE: Diagnostic procedures, such as bone mineral density testing and x-ray, help measure bone loss in women receiving treatment for breast cancer. The test results may help doctors plan better treatment. PURPOSE: This phase III trial is studying bone density and bone loss in postmenopausal women with breast cancer receiving treatment in clinical trial IBCSG-1-98.
Detailed Description: OBJECTIVES: * Compare the effects on bone mineral density (BMD) in the L2-L4 (posterio-anterior) region of the spine and hip by assessing bone density in postmenopausal women with breast cancer receiving treatment on protocol IBCSG-1-98. * Compare the incidence of radiological gross changes and fractures identified from spine x-rays (T4-L4) in these patients (in groups 1 and 2). * Use longitudinal BMD measurements to estimate a linear rate of bone loss based on mixed effect models. * Identify serum markers for bone loss to determine how they correlate with osteoporosis, microfractures, clinical fractures, and breast cancer-related bone events. OUTLINE: This is a multicenter study and a substudy of protocol IBCSG-1-98. Patients are assigned to 1 of 3 groups according to the length of treatment they have undergone on protocol IBCSG-1-98. * Group 1 (prior to or at the end of the second year of treatment on protocol IBCSG-1-98): Patients undergo bone mineral density (BMD) testing of the L2-L4 spine and hip at baseline and years 1, 2, 3, and 4 from baseline. They also undergo x-rays of the T4-L4 spine at baseline and years 1, 3, and 4 from baseline. * Group 2 (after 2 years but before the end of the third year of treatment on protocol IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and years 1, 2, and 3 from baseline. They also undergo x-rays of the T4-L4 spine at baseline and years 2 and 3 from baseline. * Group 3 (after 3 years but before the end of the fifth year of treatment on protocol IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and years 1 and 2 from baseline (for patients in 4th year of treatment) or year 1 from baseline (for patients in 5th year of treatment). Patients undergo blood collection at baseline and periodically during study for biomarker correlative study. PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study.
Minimum Age: 30 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Institute of Oncology at Prince of Wales Hospital, Randwick, New South Wales, Australia
Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
Institut Bergonie, Bordeaux, , France
Centro di Riferimento Oncologico - Aviano, Aviano, , Italy
Ospedali Riuniti di Bergamo, Bergamo, , Italy
European Institute of Oncology, Milano, , Italy
Dunedin Hospital, Dunedin, , New Zealand
Instituto Nacional de Enfermedades Neoplasicas, Lima, , Peru
Groote Schuur Hospital, Cape Town, , South Africa
Hospital Ruber Internacional, Madrid, , Spain
Kantonspital Aarau, Aarau, , Switzerland
Inselspital Bern, Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Ospedale Beata Vergine, Mendrisio, , Switzerland
Kantonsspital - St. Gallen, St. Gallen, , Switzerland
Regionalspital, Thun, , Switzerland
Name: Stefan Aebi, MD
Affiliation: Insel Gruppe AG, University Hospital Bern
Role: STUDY_CHAIR
Name: Andrea Decensi, MD
Affiliation: European Institute of Oncology
Role: STUDY_CHAIR