Breast Cancer Women on Aromatase Inhibitors Treatment

NCT03811509 | Unknown Phase 4 DMC

• 1 other identifier: 4604010730
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoporosis; Osteoporosis Fracture; Arthralgia Generalized

Keywords

osteoporosis; aromatase inhibitors; breast cancer; microindentation; arthralgia; musculoskeletal pain

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Bone Mineral Strength (BMSi)

  bone microindentation

  change from baseline, 12 months, and 60 months of aromatase treatment

• 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 Outcomes (2)

• bone turnover markers

  change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment

• cartilage degradation markers

  change from baseline and 12 months of aromatase treatment

Study Arms (2)

AI with osteoporosis

ACTIVE COMPARATOR

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: bisphosphonate

AI without osteoporosis

NO INTERVENTION

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.

Interventions

bisphosphonate DRUG

antiresorptives

Also known as: denosumab

AI with osteoporosis

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women with early breast cancer estrogen receptor with aromatase inhibitors treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Xavier Nogues

Barcelona, 08015, Spain

RECRUITING

Related Publications (4)

• Servitja S, Nogues X, Prieto-Alhambra D, Martinez-Garcia M, Garrigos L, Pena MJ, de Ramon M, Diez-Perez 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.

  PMID: 21924904 BACKGROUND

• Nogues X, Servitja S, Pena 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.

  PMID: 20399042 BACKGROUND

• 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(5):291-6. doi: 10.1177/1758834015598536.

  PMID: 26327926 RESULT

• Pineda-Moncusi M, Servitja S, Tusquets I, Diez-Perez A, Rial A, Cos ML, Campodarve I, Rodriguez-Morera J, Garcia-Giralt N, Nogues X. Assessment of early therapy discontinuation and health-related quality of life in breast cancer patients treated with aromatase inhibitors: B-ABLE cohort study. Breast Cancer Res Treat. 2019 Aug;177(1):53-60. doi: 10.1007/s10549-019-05289-7. Epub 2019 May 24.

  PMID: 31127467 DERIVED

MeSH Terms

Conditions

Osteoporosis; Osteoporotic Fractures; Breast Neoplasms; Arthralgia; Musculoskeletal Pain

Interventions

Diphosphonates; Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fractures, Bone; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Xavier Nogues, MD

CONTACT

34932483246; xnogues@parcdesalutmar.cat

Natalia Garcia-Giralt, PhD

CONTACT

34933160445; ngarcia@imim.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patents receive aromatase inhibitors Patients without osteoporosis receive only calcium and vitamin D Patients with osteoporosis receive antiresorptive treatment

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: January 22, 2019
• Study Start: January 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: December 31, 2022
• Last Updated: January 28, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available in the next year and every time we have outcomes available
• Access Criteria: By asking CEIC Parc de Salut Mar

Locations

ES (1)