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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03811509
Recruitment Status : Recruiting
First Posted : January 22, 2019
Last Update Posted : January 28, 2019
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Osteoporosis Osteoporosis Fracture Arthralgia Generalized Drug: bisphosphonate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Study for Improving Life Quality in Breast Cancer Women Treated With Aromatase Inhibitors: Cohort B-ABLE
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

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 Name: 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.



Primary Outcome Measures :
  1. 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

  2. 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

  3. Bone Mineral Strength (BMSi) [ Time Frame: change from baseline, 12 months, and 60 months of aromatase treatment ]
    bone microindentation

  4. 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


Secondary Outcome Measures :
  1. 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)

  2. cartilage degradation markers [ Time Frame: change from baseline and 12 months of aromatase treatment ]
    C-telopeptide II, Procollagen type 2 amino-terminal propeptide (P2NP)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811509


Contacts
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Contact: Xavier Nogues, MD 34932483246 xnogues@parcdesalutmar.cat
Contact: Natalia Garcia-Giralt, PhD 34933160445 ngarcia@imim.es

Locations
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Spain
Xavier Nogues Recruiting
Barcelona, Spain, 08015
Contact: Xavier Nogues, MD    932483246    xnogues@parcdesalutmar.cat   
Contact: Natalia Garcia-Giralt, Phd    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         
Sponsors and Collaborators
Parc de Salut Mar
Instituto de Salud Carlos III
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT03811509    
Other Study ID Numbers: 4604010730
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication in Oncology , Endocrinology and bone metabolism journals
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Parc de Salut Mar:
osteoporosis
aromatase inhibitors
breast cancer
microindentation
arthralgia
musculoskeletal pain
Additional relevant MeSH terms:
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Osteoporosis
Arthralgia
Osteoporotic Fractures
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Joint Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Fractures, Bone
Wounds and Injuries
Denosumab
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs