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CompletedNCT05049031IMPACTTHKSUpdated Mar 2, 2022

Impact of Adjuvant Hormone Therapy on Bone and Cardiovascular Risk

An interventional study of Questionnaire in Breast Cancer, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-03-02.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
Female
01

Study summary

Breast cancer is the most frequently observed cancer in women in France.The mortality rate is still decreasing with a decrease of 1.6% per year between 2010 and 2018, explained by the improvement in available treatments.For patients with breast cancer expressing hormone receptors, treatment with Tamoxifen or anti-aromatase can have the risk of the cancer coming back.However, these treatments have many side effects, including the risk of osteoporosis and metabolic disorders with anti-aromatases; and arterial and thromboembolic accidents with Tamoxifen.These effects have been well studied while taking hormone therapy.However, very few studies have analyzed the impact of these treatments after stopping them in women who have had non-metastatic hormone-sensitive breast cancer and uncertainties persist on the evolution of the health risk after initial treatment.

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Conditions studied

  • Breast Cancer

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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 102 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients who had T1-T3, N0-N2, M0 breast cancer
  • Patients referred to the Menopause center in the context of their breast cancer who were included in the original study evaluating the bone impact of hormone therapy carried out between 2010 "Bone and cardiovascular impact of adjuvant hormone therapy for cancer non-metastatic breast "
  • Patient who has given her consent for the study (written or verbal) after clear and fair information

Exclusion criteria

Exclusion Criteria:

  • Metastatic breast tumor
  • Absence of adjuvant hormone therapy for patients whose tumor did not express hormone receptors
  • Patients who have died since the last assessment
  • Protected adult patient (guardianship, curatorship, safeguard of justice)
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    Breast cancer treated with hormone therapy

    Adult patients with T1-T3, N0-N2, M0 breast cancer and referred to the Menopause Center of Toulouse Hospital for their breast cancer

    Other: Questionnaire

Interventions

  • OtherQuestionnaire

    A questionnaire will be given to patients who will ask them about their possible fractures, their bone and oncological follow-ups and their possible cardiovascular events since the end of treatment with hormone therapy.

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What researchers measure

Primary outcomes

  1. Evaluate the bone impact of hormone therapy remotely

    A questionnaire asking patients if they have fractures since stopping the treatment will be offered.

    Time frame: Inclusion day (day 0)

  2. Evaluate the cardiovascular impact of hormone therapy remotely

    A questionnaire asking patients if they have had a cardiovascular problem since stopping treatment will be offered.

    Time frame: Inclusion day (day 0)

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Study locations

1 site
  • CHU Toulouse
    Toulouse, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05049031
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Sep 17, 2021
Start date
Oct 6, 2021
Primary completion
Feb 1, 2022
Completion
Feb 1, 2022
Last update
Mar 2, 2022

Study contacts

Anna Gosset, MD
principal investigator · CHU Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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