Breast Cancer Women on Aromatase Inhibitors Treatment (B-ABLE)

January 25, 2019 updated by: Parc de Salut Mar

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Natalia Garcia-Giralt, PhD
  • Phone Number: 34933160445
  • Email: ngarcia@imim.es

Study Locations

  • Spain
      • Barcelona, Spain, 08015
        • Recruiting
        • Xavier Nogues
        • Contact:
        • Contact:
          • Natalia Garcia-Giralt, Phd
          • Phone Number: 34933160445
        • Sub-Investigator:
          • Sonia Servitja, MD
        • Sub-Investigator:
          • Ignasi Tusquets, MD
        • Sub-Investigator:
          • Marta Pineda, PhD
        • Sub-Investigator:
          • Isabel Aymar
        • Sub-Investigator:
          • Jaime Rodriguez-Morera, MD
        • Sub-Investigator:
          • Adolfo Díez-Pérez, MD
        • Sub-Investigator:
          • Maria Martinez, MD
        • Sub-Investigator:
          • Tamara Martos, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AI with osteoporosis
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
antiresorptives
Other Names:
  • denosumab
No Intervention: AI without osteoporosis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone mass measured by dual energy x-ray absorptiometry (DEXA) densitometry
Time Frame: 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
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
Time Frame: 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
incidence of new fractures at 12 months, 24 months, 36 months, 48 months 60 months of aromatase treatment
Bone Mineral Strength (BMSi)
Time Frame: change from baseline, 12 months, and 60 months of aromatase treatment
bone microindentation
change from baseline, 12 months, and 60 months of aromatase treatment
Arthralgia
Time Frame: 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
change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone turnover markers
Time Frame: 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)
change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment
cartilage degradation markers
Time Frame: change from baseline and 12 months of aromatase treatment
C-telopeptide II, Procollagen type 2 amino-terminal propeptide (P2NP)
change from baseline and 12 months of aromatase treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Collaborators

Instituto de Salud Carlos III

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

January 17, 2019

First Posted (Actual)

January 22, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2019

Last Update Submitted That Met QC Criteria

January 25, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4604010730

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Publication in Oncology , Endocrinology and bone metabolism journals

IPD Sharing Time Frame

Data will become available in the next year and every time we have outcomes available

IPD Sharing Access Criteria

By asking CEIC Parc de Salut Mar

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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