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

Primary Purpose

Osteoporosis, Osteoporosis Fracture, Arthralgia Generalized

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
bisphosphonate
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring osteoporosis, aromatase inhibitors, breast cancer, microindentation, arthralgia, musculoskeletal pain

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Xavier NoguesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

AI with osteoporosis

AI without osteoporosis

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
Fragility fractures assessed by xRay
vertebral and non vertebral fractures, hip fractures
Bone Mineral Strength (BMSi)
bone microindentation
Arthralgia
joint pain measured by analogic visual scale range 0= no pain 10= worse pain

Secondary Outcome Measures

bone turnover markers
C-telopeptide (Ctx), Procollagen type 1 amino-terminal propeptide (P1NP) Bone Alkaline Phosphatase (AP)
cartilage degradation markers
C-telopeptide II, Procollagen type 2 amino-terminal propeptide (P2NP)

Full Information

First Posted
December 17, 2018
Last Updated
January 25, 2019
Sponsor
Parc de Salut Mar
Collaborators
Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT03811509
Brief Title
Breast Cancer Women on Aromatase Inhibitors Treatment
Acronym
B-ABLE
Official Title
Study for Improving Life Quality in Breast Cancer Women Treated With Aromatase Inhibitors: Cohort B-ABLE
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parc de Salut Mar
Collaborators
Instituto de Salud Carlos III

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteoporosis Fracture, Arthralgia Generalized
Keywords
osteoporosis, aromatase inhibitors, breast cancer, microindentation, arthralgia, musculoskeletal pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
All patents receive aromatase inhibitors Patients without osteoporosis receive only calcium and vitamin D Patients with osteoporosis receive antiresorptive treatment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AI with osteoporosis
Arm Type
Active Comparator
Arm Description
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.
Arm Title
AI without osteoporosis
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
bisphosphonate
Other Intervention Name(s)
denosumab
Intervention Description
antiresorptives
Primary Outcome Measure Information:
Title
bone mass measured by dual energy x-ray absorptiometry (DEXA) densitometry
Description
bone mas normal, osteopenia or osteoporosis related with WHO definition of osteoporosis and Trabecular Bone Score: normal, mild degratation and high degradation
Time Frame
change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment
Title
Fragility fractures assessed by xRay
Description
vertebral and non vertebral fractures, hip fractures
Time Frame
incidence of new fractures at 12 months, 24 months, 36 months, 48 months 60 months of aromatase treatment
Title
Bone Mineral Strength (BMSi)
Description
bone microindentation
Time Frame
change from baseline, 12 months, and 60 months of aromatase treatment
Title
Arthralgia
Description
joint pain measured by analogic visual scale range 0= no pain 10= worse pain
Time Frame
change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment
Secondary Outcome Measure Information:
Title
bone turnover markers
Description
C-telopeptide (Ctx), Procollagen type 1 amino-terminal propeptide (P1NP) Bone Alkaline Phosphatase (AP)
Time Frame
change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment
Title
cartilage degradation markers
Description
C-telopeptide II, Procollagen type 2 amino-terminal propeptide (P2NP)
Time Frame
change from baseline and 12 months of aromatase treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier Nogues, MD
Phone
34932483246
Email
xnogues@parcdesalutmar.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Garcia-Giralt, PhD
Phone
34933160445
Email
ngarcia@imim.es
Facility Information:
Facility Name
Xavier Nogues
City
Barcelona
ZIP/Postal Code
08015
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Nogues, MD
Phone
932483246
Email
xnogues@parcdesalutmar.cat
First Name & Middle Initial & Last Name & Degree
Natalia Garcia-Giralt, Phd
Phone
34933160445
First Name & Middle Initial & Last Name & Degree
Sonia Servitja, MD
First Name & Middle Initial & Last Name & Degree
Ignasi Tusquets, MD
First Name & Middle Initial & Last Name & Degree
Marta Pineda, PhD
First Name & Middle Initial & Last Name & Degree
Isabel Aymar
First Name & Middle Initial & Last Name & Degree
Jaime Rodriguez-Morera, MD
First Name & Middle Initial & Last Name & Degree
Adolfo Díez-Pérez, MD
First Name & Middle Initial & Last Name & Degree
Maria Martinez, MD
First Name & Middle Initial & Last Name & Degree
Tamara Martos, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
21924904
Citation
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.
Results Reference
background
PubMed Identifier
20399042
Citation
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.
Results Reference
background
PubMed Identifier
26327926
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(5):291-6. doi: 10.1177/1758834015598536.
Results Reference
result
PubMed Identifier
31127467
Citation
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.
Results Reference
derived

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Breast Cancer Women on Aromatase Inhibitors Treatment

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