Evaluation of the Functional/Emotional Life Characteristics of Ongoing EAT in BC Patients With Reduced BMD

NCT05779566 | Completed DMC

• 1 other identifier: 2022/005-OST
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Exploratory evaluation of the Functional/Emotional Life characteristics during the first year of ongoing endocrine adjuvant treatment with Aromatase Inhibitors in Breast Cancer patients (BCP) with reduced Bone Mineral Density (BMD)

Conditions

Breast Cancer; Osteopenia

Outcome Measures

Primary Outcomes (1)

• Bone mineral density (BMD)

  Chronic osteopenia, as a result of significant reduction of BMD, is expected to significantly negatively affect Functional Life characteristics in BCPs undergoing adjuvant endocrine aromatase inhibitors treatments in comparison to those with milder symptomatology. The association of the long-term outcomes of the PROM Index with the trajectory of reduced BMD-related symptomatology, as well as the Functional Life Index progression will be examined as an estimate of the safety and the effectiveness of the aromatase inhibitor adjuvant endocrine therapy. It is expected that the severity of reduced BMD-related symptomatology is associated with further deterioration of the Functional Life Index. Units: gr/cm\^2

  1 year

Secondary Outcomes (4)

• Adjuvant treatment compliance

  1 year

• Weight

  1 year

• Height

  1 year

• C-Telopeptide concentration

  1 year

Study Arms (2)

OST

Patients with osteoporosis or severe osteopenia defined as having a significantly reduced BMD (T-score equal or lower than -1.5)

Diagnostic Test: bone densitometry

Mild OST

Patients with mild-to-no reduction of BMD at the same post-treatment time point (T-score higher than -1.5)

Diagnostic Test: bone densitometry

Interventions

bone densitometry DIAGNOSTIC_TEST

bone densitometry every 6 month

Mild OST; OST

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study participant recruitment pool will be the whole population of BCPs undergoing endocrine adjuvant treatment (aromatase inhibitors) in the Oncology Department at Hospital Clínico de Valencia (Spain). As part of the ongoing patient follow-up, potential candidates with significant or milder reductions in BMD will be identified at study inclusion (early stages of adjuvant treatment period) based on comparisons with standard population BM measures (i.e., densitometry examination outcome: T-score lower than -1.0211). At this point, appropriate patients interested in the study will be informed about the study and written consents will be obtained. All the potential participants will be female due to the nature of Breast Cancer

You may qualify if:

• Before patient registration, written informed consent must be given according to national and local regulations.
• Participants have had histologically proven stage I-III breast cancer undergoing endocrine treatment (with or without prior chemotherapy) no more than 12 months prior to randomization.
• Be between 18 and 75 years of age.
• Have increased life expectancy beyond the initial 3 months post-treatment initiation.
• Have the ability to understand protocol, participate in testing and willingness to sign a written informed consent.
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

You may not qualify if:

• Patients already diagnosed with Osteopenia/Osteoporosis and already receiving BMD treatment (bisphosphonates or denosumab)
• Patients already diagnosed with osteopenia/osteoporosis who have already suffered a bone event related to decreased BMD
• Patients that are not willing to sign an informed consent form

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: March 22, 2023
• Study Start: January 9, 2023
• Primary Completion: January 31, 2024
• Study Completion: June 30, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

ES (1)