⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Bone Density and Bone Loss in Postmenopausal Women With Breast Cancer Receiving Treatment in Clinical Trial IBCSG-1-98

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 30 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: