Clinical trial · Observational
Evaluation of the Functional/Emotional Life Characteristics of Ongoing EAT in BC Patients With Reduced BMD
Exploratory Evaluation of the Functional/Emotional Life Characteristics During the First Year of Ongoing Endocrine Adjuvant Treatment With Aromatase Inhibitors in Breast Cancer Patients With Reduced Bone Mineral Density
NCT05779566CI-TRIAL-00086534REBECCA-OSTcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Osteopenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bone densitometry | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- OST
- description
- Patients with osteoporosis or severe osteopenia defined as having a significantly reduced BMD (T-score equal or lower than -1.5)
- interventionNames
- Diagnostic Test: bone densitometry
- label
- Mild OST
- description
- Patients with mild-to-no reduction of BMD at the same post-treatment time point (T-score higher than -1.5)
- interventionNames
- Diagnostic Test: bone densitometry
Primary outcomes (1)
- measure
- Bone mineral density (BMD)
- timeFrame
- 1 year
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.