<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03811509</url>
  </required_header>
  <id_info>
    <org_study_id>4604010730</org_study_id>
    <nct_id>NCT03811509</nct_id>
  </id_info>
  <brief_title>Breast Cancer Women on Aromatase Inhibitors Treatment</brief_title>
  <acronym>B-ABLE</acronym>
  <official_title>Study for Improving Life Quality in Breast Cancer Women Treated With Aromatase Inhibitors: Cohort B-ABLE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Parc de Salut Mar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Salud Carlos III</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Parc de Salut Mar</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of the study is to improve the life quality of women treated with AI.&#xD;
      Cohort B-ABLE is designed to evaluate musculoskeletal events derived of using AI in breast&#xD;
      cancer women. The project objectives are the analysis of the AI deleterious effect on bone&#xD;
      microarchitecture and early determination of the risk of fragility fracture with dual energy&#xD;
      x-ray absorptiometry (DEXA), lumbar spine Rx, Trabecular Bone Score (TBS) and&#xD;
      microindentation. Determination of physiological causes of the AI-related arthralgia by&#xD;
      analyzing joint degradation markers, steroid hormone levels remaining in blood and functional&#xD;
      magnetic resonance, before and after three months of AI treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postmenopausal women with breast cancer treated with aromatase inhibitors (AI) have a higher&#xD;
      incidence of osteoporosis, fractures and other musculoskeletal symptoms, particularly pain&#xD;
      and stiffness. B-ABLE is a clinical, prospective cohort study carried out in both Breast&#xD;
      Cancer and Bone Metabolism Units of the Hospital del Mar in Barcelona. Currently, 780&#xD;
      postmenopausal Caucasian women with early breast cancer and candidates for adjuvant AI&#xD;
      treatment were included and predicted to reach more than 1000 patients. The main objective of&#xD;
      the study is to improve the life quality of women treated with AI. Cohort B-ABLE is designed&#xD;
      to evaluate musculoskeletal events derived of using AI in breast cancer women. The project&#xD;
      objectives are the analysis of the AI deleterious effect on bone microarchitecture and early&#xD;
      determination of the risk of fragility fracture with DEXA, lumbar spine Rx, TBS and&#xD;
      microindentation. Determination of physiological causes of the AI-related arthralgia by&#xD;
      analyzing joint degradation markers, steroid hormone levels remaining in blood and functional&#xD;
      magnetic resonance, before and after three months of AI treatment. The study results will&#xD;
      help to decide the most appropriate treatment for each patient in order to minimize&#xD;
      AI-related side effects and hence avoid discontinuation of adjuvant therapy treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>All patents receive aromatase inhibitors Patients without osteoporosis receive only calcium and vitamin D Patients with osteoporosis receive antiresorptive treatment</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>bone mass measured by dual energy x-ray absorptiometry (DEXA) densitometry</measure>
    <time_frame>change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment</time_frame>
    <description>bone mas normal, osteopenia or osteoporosis related with WHO definition of osteoporosis and Trabecular Bone Score: normal, mild degratation and high degradation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fragility fractures assessed by xRay</measure>
    <time_frame>incidence of new fractures at 12 months, 24 months, 36 months, 48 months 60 months of aromatase treatment</time_frame>
    <description>vertebral and non vertebral fractures, hip fractures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bone Mineral Strength (BMSi)</measure>
    <time_frame>change from baseline, 12 months, and 60 months of aromatase treatment</time_frame>
    <description>bone microindentation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arthralgia</measure>
    <time_frame>change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment</time_frame>
    <description>joint pain measured by analogic visual scale range 0= no pain 10= worse pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>bone turnover markers</measure>
    <time_frame>change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment</time_frame>
    <description>C-telopeptide (Ctx), Procollagen type 1 amino-terminal propeptide (P1NP) Bone Alkaline Phosphatase (AP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cartilage degradation markers</measure>
    <time_frame>change from baseline and 12 months of aromatase treatment</time_frame>
    <description>C-telopeptide II, Procollagen type 2 amino-terminal propeptide (P2NP)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Osteoporosis</condition>
  <condition>Osteoporosis Fracture</condition>
  <condition>Arthralgia Generalized</condition>
  <arm_group>
    <arm_group_label>AI with osteoporosis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AI without osteoporosis</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bisphosphonate</intervention_name>
    <description>antiresorptives</description>
    <arm_group_label>AI with osteoporosis</arm_group_label>
    <other_name>denosumab</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postmenopausal women with early breast cancer estrogen receptor with aromatase&#xD;
             inhibitors treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment with antiresorptive treatment for osteoporosis secondary&#xD;
             osteoporosis, as corticosteroids, Hyperparathyroidism, Kidney Chronic disease,&#xD;
             previous treatment with aromatase inhibitors Diabetes mellitus type 1 Fibromyalgia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xavier Nogues, MD</last_name>
    <phone>34932483246</phone>
    <email>xnogues@parcdesalutmar.cat</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Natalia Garcia-Giralt, PhD</last_name>
    <phone>34933160445</phone>
    <email>ngarcia@imim.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xavier Nogues</name>
      <address>
        <city>Barcelona</city>
        <zip>08015</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xavier Nogues, MD</last_name>
      <phone>932483246</phone>
      <email>xnogues@parcdesalutmar.cat</email>
    </contact>
    <contact_backup>
      <last_name>Natalia Garcia-Giralt, Phd</last_name>
      <phone>34933160445</phone>
    </contact_backup>
    <investigator>
      <last_name>Sonia Servitja, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ignasi Tusquets, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marta Pineda, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Isabel Aymar</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jaime Rodriguez-Morera, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Adolfo Díez-Pérez, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maria Martinez, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tamara Martos, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>21924904</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20399042</PMID>
  </reference>
  <results_reference>
    <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.</citation>
    <PMID>26327926</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>osteoporosis</keyword>
  <keyword>aromatase inhibitors</keyword>
  <keyword>breast cancer</keyword>
  <keyword>microindentation</keyword>
  <keyword>arthralgia</keyword>
  <keyword>musculoskeletal pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Arthralgia</mesh_term>
    <mesh_term>Osteoporotic Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Denosumab</mesh_term>
    <mesh_term>Diphosphonates</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Publication in Oncology , Endocrinology and bone metabolism journals</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will become available in the next year and every time we have outcomes available</ipd_time_frame>
    <ipd_access_criteria>By asking CEIC Parc de Salut Mar</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03811509
org study id: 4604010730
nct id: NCT03811509
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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
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.
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
primary purpose: Prevention
masking: None (Open Label)
measure: 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
description: bone mas normal, osteopenia or osteoporosis related with WHO definition of osteoporosis and Trabecular Bone Score: normal, mild degratation and high degradation
measure: 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
description: vertebral and non vertebral fractures, hip fractures
measure: Bone Mineral Strength (BMSi)
time frame: change from baseline, 12 months, and 60 months of aromatase treatment
description: bone microindentation
measure: Arthralgia
time frame: change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment
description: joint pain measured by analogic visual scale range 0= no pain 10= worse pain
measure: 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
description: C-telopeptide (Ctx), Procollagen type 1 amino-terminal propeptide (P1NP) Bone Alkaline Phosphatase (AP)
measure: cartilage degradation markers
time frame: change from baseline and 12 months of aromatase treatment
description: C-telopeptide II, Procollagen type 2 amino-terminal propeptide (P2NP)
arm group label: AI with osteoporosis
arm group type: Active Comparator
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 group label: AI without osteoporosis
arm group type: No Intervention
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: bisphosphonate
description: antiresorptives
arm group label: AI with osteoporosis
other name: denosumab
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xavier Nogues, MD
phone: 34932483246
email: xnogues@parcdesalutmar.cat
last name: Natalia Garcia-Giralt, PhD
phone: 34933160445
email: ngarcia@imim.es
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Spain
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.
PMID: 21924904
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.
PMID: 20399042
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.
PMID: 26327926
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Arthralgia
mesh term: Osteoporotic Fractures
mesh term: Denosumab
mesh term: Diphosphonates
sharing ipd: Yes
ipd description: Publication in Oncology , Endocrinology and bone metabolism journals
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will become available in the next year and every time we have outcomes available
ipd access criteria: By asking CEIC Parc de Salut Mar