Breast Cancer Women on Aromatase Inhibitors Treatment

Phase 4

• Conditions: Osteoporosis Fracture; Osteoporosis; Arthralgia Generalized
• Interventions: Drug: bisphosphonate

• Registration Number: NCT03811509
• Lead Sponsor: Parc de Salut Mar

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.

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2018-08
• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-22
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-28
• Primary Completion: 2021-01-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AI with osteoporosis	bisphosphonate	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.

Primary Outcome Measures

Name	Time	Method
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
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 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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Xavier Nogues; 🇪🇸 Barcelona, Spain