Breast Cancer Women on Aromatase Inhibitors Treatment

Osteoporosis Clinical Trial

— B-ABLE  

Official title:

Study for Improving Life Quality in Breast Cancer Women Treated With Aromatase Inhibitors: Cohort B-ABLE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03811509
• Other study ID #: 4604010730
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2018
• Source: Parc de Salut Mar
• Contact: Xavier Nogues, MD
• Phone: 34932483246
• Email: xnogues[@]parcdesalutmar.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2022
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Arthralgia Generalized
• Breast Neoplasms
• Osteoporosis
• Osteoporosis Fracture
• Osteoporotic Fractures

Intervention

Drug:
• bisphosphonate
antiresorptives

Locations

Country	Name	City	State
Spain	Xavier Nogues	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Parc de Salut Mar	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Nogues X, Servitja S, Peña MJ, Prieto-Alhambra D, Nadal R, Mellibovsky L, Albanell J, Diez-Perez A, Tusquets I. Vitamin D deficiency and bone mineral density in postmenopausal women receiving aromatase inhibitors for early breast cancer. Maturitas. 2010 Jul;66(3):291-7. doi: 10.1016/j.maturitas.2010.03.012. Epub 2010 Apr 15. — View Citation

Servitja S, Martos T, Rodriguez Sanz M, Garcia-Giralt N, Prieto-Alhambra D, Garrigos L, Nogues X, Tusquets I. Skeletal adverse effects with aromatase inhibitors in early breast cancer: evidence to date and clinical guidance. Ther Adv Med Oncol. 2015 Sep;7 — View Citation

Servitja S, Nogués X, Prieto-Alhambra D, Martínez-García M, Garrigós L, Peña MJ, de Ramon M, Díez-Pérez A, Albanell J, Tusquets I. Bone health in a prospective cohort of postmenopausal women receiving aromatase inhibitors for early breast cancer. Breast. 2012 Feb;21(1):95-101. doi: 10.1016/j.breast.2011.09.001. Epub 2011 Sep 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone mass measured by dual energy x-ray absorptiometry (DEXA) densitometry	bone mas normal, osteopenia or osteoporosis related with WHO definition of osteoporosis and Trabecular Bone Score: normal, mild degratation and high degradation	change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment
Primary	Fragility fractures assessed by xRay	vertebral and non vertebral fractures, hip fractures	incidence of new fractures at 12 months, 24 months, 36 months, 48 months 60 months of aromatase treatment
Primary	Bone Mineral Strength (BMSi)	bone microindentation	change from baseline, 12 months, and 60 months of aromatase treatment
Primary	Arthralgia	joint pain measured by analogic visual scale range 0= no pain 10= worse pain	change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment
Secondary	bone turnover markers	C-telopeptide (Ctx), Procollagen type 1 amino-terminal propeptide (P1NP) Bone Alkaline Phosphatase (AP)	change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment
Secondary	cartilage degradation markers	C-telopeptide II, Procollagen type 2 amino-terminal propeptide (P2NP)	change from baseline and 12 months of aromatase treatment