Breast Cancer Women on Aromatase Inhibitors Treatment
NCT03811509 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000
Last updated 2019-01-28
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
Conditions
- Osteoporosis
- Osteoporosis Fracture
- Arthralgia Generalized
Interventions
- DRUG
-
bisphosphonate
antiresorptives
Sponsors & Collaborators
-
Instituto de Salud Carlos III
collaborator OTHER_GOV -
Parc de Salut Mar
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-01
- Primary Completion
- 2021-01-01
- Completion
- 2022-12-31
Countries
- Spain
Study Locations
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