Breast Cancer Women on Aromatase Inhibitors Treatment
Keywords
Abstract
Description
Postmenopausal women with breast cancer treated with aromatase inhibitors (AI) have a higher incidence of osteoporosis, fractures and other musculoskeletal symptoms, particularly pain and stiffness. B-ABLE is a clinical, prospective cohort study carried out in both Breast Cancer and Bone Metabolism Units of the Hospital del Mar in Barcelona. Currently, 780 postmenopausal Caucasian women with early breast cancer and candidates for adjuvant AI treatment were included and predicted to reach more than 1000 patients. The main objective of the study is to improve the life quality of women treated with AI. Cohort B-ABLE is designed to evaluate musculoskeletal events derived of using AI in breast cancer women. The project objectives are the analysis of the AI deleterious effect on bone microarchitecture and early determination of the risk of fragility fracture with DEXA, lumbar spine Rx, TBS and microindentation. Determination of physiological causes of the AI-related arthralgia by analyzing joint degradation markers, steroid hormone levels remaining in blood and functional magnetic resonance, before and after three months of AI treatment. The study results will help to decide the most appropriate treatment for each patient in order to minimize AI-related side effects and hence avoid discontinuation of adjuvant therapy treatment.
Dates
| Last Verified: | 07/31/2018 |
| First Submitted: | 12/16/2018 |
| Estimated Enrollment Submitted: | 01/16/2019 |
| First Posted: | 01/21/2019 |
| Last Update Submitted: | 01/24/2019 |
| Last Update Posted: | 01/27/2019 |
| Actual Study Start Date: | 12/31/2015 |
| Estimated Primary Completion Date: | 12/31/2020 |
| Estimated Study Completion Date: | 12/30/2022 |
Condition or disease
Intervention/treatment
Drug: AI with osteoporosis
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: AI with osteoporosis Patients with osteoporosis receive intervention with antiresorptive treatment, bisphosphonates or denosumab . All patients receive calcium and Vit D supplements All patients receive by protocol aromatase inhibitors for breast cancer treatment, letrozole, exemestane for 5 o 10 years. | Drug: AI with osteoporosis antiresorptives |
| No Intervention: AI without osteoporosis All patients receive calcium and Vit D supplements All patients receive by protocol aromatase inhibitors for breast cancer treatment, letrozole, exemestane for 5 o 10 years. |
Eligibility Criteria
| Ages Eligible for Study | 40 Years To 40 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Postmenopausal women with early breast cancer estrogen receptor with aromatase inhibitors treatment Exclusion Criteria: - Previous treatment with antiresorptive treatment for osteoporosis secondary osteoporosis, as corticosteroids, Hyperparathyroidism, Kidney Chronic disease, previous treatment with aromatase inhibitors Diabetes mellitus type 1 Fibromyalgia |
Outcome
Primary Outcome Measures
1. bone mass measured by dual energy x-ray absorptiometry (DEXA) densitometry [change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment]
2. Fragility fractures assessed by xRay [incidence of new fractures at 12 months, 24 months, 36 months, 48 months 60 months of aromatase treatment]
3. Bone Mineral Strength (BMSi) [change from baseline, 12 months, and 60 months of aromatase treatment]
4. Arthralgia [change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment]
Secondary Outcome Measures
1. bone turnover markers [change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment]
2. cartilage degradation markers [change from baseline and 12 months of aromatase treatment]
