Breast CancerREBECCA-OSTNCT05779566
Evaluation of the Functional/Emotional Life Characteristics of Ongoing EAT in BC Patients With Reduced BMD
An observational study of Breast Cancer and Osteopenia, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Osteopenia
- What is being tested?
- bone densitometry
- How many people
- 82 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jan 2023to 30 Jun 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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)
Read the detailed description
Many breast cancer therapies cause decreases in bone mineral density (BMD), as a result of oestrogen deprivation, a well-established risk factor for osteopenia (OST), osteoporosis and bone fractures. That leads to breast cancer patients having reduced bone mass, leading to higher risk for bone osteoporosis-related fractures, compared with age-matched healthy women, necessitating routine bone health assessments after a diagnosis of breast cancer. Such treatments include adjuvant endocrine therapies (e.g., tamoxifen and aromatase inhibitors) commonly used for hormone receptor-positive breast cancers, the most common type of breast cancer.
Additionally, chemotherapy or ablation of ovarian function (either medically or surgically) can lead to premature menopause among younger women and further reduce BMD5. Despite the advances in the pharmacology managing cancer treatment-induced osteopenia, the long-term efficacy of drug effects is debatable6 and there are numerous concerns about rare (but significant) side-effects of anti-resorptive drugs, particularly bisphosphonates. Those challenges necessitate additional research for the optimal OST management as a chronic breast cancer comorbidity.
Thus, the elucidation of the precise onset and progress of OST in patients and its interaction with lifestyle and high risk behaviours are now receiving increased research attention, aiming at the identification of novel patient management strategies to alleviate the chronic effects of the condition.
In order to counter the important life-effects of OST in breast cancer patients, current disease management schemes propose the integration of non-pharmacologic measures to maintain (or improve) optimal bone health, such as weight-bearing exercises and calcium and vitamin D supplementation. However, the lack of objective RWD on the effects of increased BMD on lifestyle is a serious challenge for the design of pragmatic and individualized patient management strategies. Indeed, lifestyle advice for increased physical activity are usually generic, lacking disease-specific knowledge, probably affecting the efficacy of exercise interventions. Overall, further evidence is required to optimise antiresorptive treatments, the use and choice of pharmacological agents, the duration of treatment and the potential of interaction with ongoing endocrine treatment.
Thus, the study will conduct the longitudinal comparison of Functional and Emotional Life Indices in Breast Cancer patients exhibiting significant reduction of BMD up to 12 months of adjuvant treatment with aromatase inhibitors, compared against matched BCPs with mild reduction of BMD. The study will use RWD to assess the safety and the effectiveness of aromatase inhibitor adjuvant endocrine therapy, with regards to osteopenia symptomatology over time. The study will consider data from 3 routine clinical evaluations (study month 0, 6 and 12) for the objective evaluation of BMD loss, complemented with continuous REBECCA use for 12 months. The collected data will include:
- Patient-reported measures: Medical and treatment history interview, project-related measurements, health-related quality of life, adjuvant treatment compliance estimation
- Medical examination: Gynecological physical and anthropometric examination, blood sampling, densitometry
For the REBECCA use, the participants will be trained in the use of the monitoring modules of the REBECCA platforms, facilitating the collection of real-world data (12 months). They will return (after 6 months) for a routine medical evaluation of osteopenia-related symptomatology and adjuvant treatment evaluation. They will complete a QoL questionnaire, and perform a structured interview, concerning mainly the appearance of new symptoms and adverse events or signs regarding bone issues, as well as a gynecological exam.
Blood tests will be collected, compliance to treatment will be evaluated and treatment satisfaction will be assessed.
The meeting will be repeated at 12 months, including a BMD examination
- Conditions
- Breast Cancer, Osteopenia
- Being tested
- bone densitometry
- Medical subject headings
- Breast Neoplasms, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone densitometryDiagnostic test
bone densitometry every 6 month
| Study group | Role | What they receive |
|---|---|---|
| OST | Patients with osteoporosis or severe osteopenia defined as having a significantly reduced BMD (T-score equal or lower than -1.5) Receives: 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) Receives: Diagnostic Test: bone densitometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (4)
Adjuvant treatment compliance
Adjuvant treatment compliance estimation (scale scored from 1 to 10)
Measured: 1 year
Weight
Weight measurement (kg) as part of the anthropometric examination
Measured: 1 year
Height
Height measurement (cm) as part of the anthropometric examination
Measured: 1 year
C-Telopeptide concentration
C-Telopeptide concentration (pg/mL) from the blood samples extracted over the course of the study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start9 Jan 2023
- Primary completion31 Jan 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779566
- Sponsor's protocol ID
- 2022/005-OST
- Acronym
- REBECCA-OST
- Status last verified
- Feb 2025
- First submitted
- 7 Oct 2022
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05779566
- Acronym / sponsor ID
- REBECCA-OST / 2022/005-OST
- Conditions
- Breast Cancer, Osteopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Many breast cancer therapies cause decreases in bone mineral density (BMD), as a result of oestrogen deprivation, a well-established risk factor for osteopenia (OST), osteoporosis and bone fractures. That leads to breast cancer patients having reduced bone mass, leading to higher risk for bone osteoporosis-related fractures, compared with age-matched healthy women, necessitating routine bone health assessments after a diagnosis of breast cancer. Such treatments include adjuvant endocrine therapies (e.g., tamoxifen and aromatase inhibitors) commonly used for hormone receptor-positive breast cancers, the most common type of breast cancer.
Additionally, chemotherapy or ablation of ovarian function (either medically or surgically) can lead to premature menopause among younger women and further reduce BMD5. Despite the advances in the pharmacology managing cancer treatment-induced osteopenia, the long-term efficacy of drug effects is debatable6 and there are numerous concerns about rare (but significant) side-effects of anti-resorptive drugs, particularly bisphosphonates. Those challenges necessitate additional research for the optimal OST management as a chronic breast cancer comorbidity.
Thus, the elucidation of the precise onset and progress of OST in patients and its interaction with lifestyle and high risk behaviours are now receiving increased research attention, aiming at the identification of novel patient management strategies to alleviate the chronic effects of the condition.
In order to counter the important life-effects of OST in breast cancer patients, current disease management schemes propose the integration of non-pharmacologic measures to maintain (or improve) optimal bone health, such as weight-bearing exercises and calcium and vitamin D supplementation. However, the lack of objective RWD on the effects of increased BMD on lifestyle is a serious challenge for the design of pragmatic and individualized patient management strategies. Indeed, lifestyle advice for increased physical activity are usually generic, lacking disease-specific knowledge, probably affecting the efficacy of exercise interventions. Overall, further evidence is required to optimise antiresorptive treatments, the use and choice of pharmacological agents, the duration of treatment and the potential of interaction with ongoing endocrine treatment.
Thus, the study will conduct the longitudinal comparison of Functional and Emotional Life Indices in Breast Cancer patients exhibiting significant reduction of BMD up to 12 months of adjuvant treatment with aromatase inhibitors, compared against matched BCPs with mild reduction of BMD. The study will use RWD to assess the safety and the effectiveness of aromatase inhibitor adjuvant endocrine therapy, with regards to osteopenia symptomatology over time. The study will consider data from 3 routine clinical evaluations (study month 0, 6 and 12) for the objective evaluation of BMD loss, complemented with continuous REBECCA use for 12 months. The collected data will include:
- Patient-reported measures: Medical and treatment history interview, project-related measurements, health-related quality of life, adjuvant treatment compliance estimation
- Medical examination: Gynecological physical and anthropometric examination, blood sampling, densitometry
For the REBECCA use, the participants will be trained in the use of the monitoring modules of the REBECCA platforms, facilitating the collection of real-world data (12 months). They will return (after 6 months) for a routine medical evaluation of osteopenia-related symptomatology and adjuvant treatment evaluation. They will complete a QoL questionnaire, and perform a structured interview, concerning mainly the appearance of new symptoms and adverse events or signs regarding bone issues, as well as a gynecological exam.
Blood tests will be collected, compliance to treatment will be evaluated and treatment satisfaction will be assessed.
The meeting will be repeated at 12 months, including a BMD examination
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OST | – | Diagnostic Test: bone densitometryPatients with osteoporosis or severe osteopenia defined as having a significantly reduced BMD (T-score equal or lower than -1.5) |
| Mild OST | – | Diagnostic Test: bone densitometryPatients with mild-to-no reduction of BMD at the same post-treatment time point (T-score higher than -1.5) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bone densitometrybone densitometry every 6 month | Diagnostic test | Mild OST, OST |
Primary outcome
Bone mineral density (BMD)
Time frame: 1 year
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
4 secondary outcomes
Adjuvant treatment compliance
Time frame: 1 year
Weight
Time frame: 1 year
Height
Time frame: 1 year
C-Telopeptide concentration
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Osteopenia, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (BMD) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.