Osteoporosis, Osteoporosis Fracture, Arthralgia Generalized
Conditions
Keywords
osteoporosis, aromatase inhibitors, breast cancer, microindentation, arthralgia, musculoskeletal pain
Brief summary
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 dual energy x-ray absorptiometry (DEXA), lumbar spine Rx, Trabecular Bone Score (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
Detailed 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.
Interventions
DRUGbisphosphonate
antiresorptives
Sponsors
Instituto de Salud Carlos III
Parc de Salut Mar
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
All patents receive aromatase inhibitors Patients without osteoporosis receive only calcium and vitamin D Patients with osteoporosis receive antiresorptive treatment
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | bone mas normal, osteopenia or osteoporosis related with WHO definition of osteoporosis and Trabecular Bone Score: normal, mild degratation and high degradation |
| Fragility fractures assessed by xRay | incidence of new fractures at 12 months, 24 months, 36 months, 48 months 60 months of aromatase treatment | vertebral and non vertebral fractures, hip fractures |
| Bone Mineral Strength (BMSi) | change from baseline, 12 months, and 60 months of aromatase treatment | bone microindentation |
| Arthralgia | change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment | joint pain measured by analogic visual scale range 0= no pain 10= worse pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bone turnover markers | change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment | C-telopeptide (Ctx), Procollagen type 1 amino-terminal propeptide (P1NP) Bone Alkaline Phosphatase (AP) |
| cartilage degradation markers | change from baseline and 12 months of aromatase treatment | C-telopeptide II, Procollagen type 2 amino-terminal propeptide (P2NP) |
Countries
Spain
Contacts
Primary ContactXavier Nogues, MD
Backup ContactNatalia Garcia-Giralt, PhD
Outcome results
None listed