Breast CancerNCT00859560
Retrospective Survey of Bone Fracture in Patients With Arimidex 1mg
An observational study of Breast Cancer, run by AstraZeneca.
Trial summary
The retrospective survey is to investigate the incidence of bone fracture in post-menopausal breast cancer patients with Arimidex 1mg, who were previously registered for the clinical experience investigation. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 2,205 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Dec 2008
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Post-menoposal breast cancer patients who were previousely registered in clinical experience investigation with Arimidex 1mg as adjuvant therapy.
Who may be able to join
- Post-menopausal breast cancer patients treated with Arimidex 1mg at the time of previously conducted clinical experience investigation.
Who cannot join
- -
About this study
Official title: Retrospective Survey of Bone Fracture in Post-Menopausal Breast Cancer Patients With Arimidex 1 mg as Adjuvant Therapy
The retrospective survey is to investigate the incidence of bone fracture in post-menopausal breast cancer patients with Arimidex 1mg, who were previously registered for the clinical experience investigation.
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, post-menopausal women, Arimidex, bone fracture
- Medical subject headings
- Breast Neoplasms, Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone fracture incidence
Measured: Time since starting Arimidex
Secondary outcomes (2)
Survival
Measured: Time since starting Arimidex
Bone density measurement
Measured: Time since starting Arimidex
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startJan 2008
- Study completionDec 2008
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.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 2,205 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Japan Medical Director MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859560
- Sponsor's protocol ID
- NIS-OJP-ARI-2007/1
- Status last verified
- Mar 2009
- First submitted
- 10 Mar 2009
- Last updated
- 11 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Survey of Bone Fracture in Post-Menopausal Breast Cancer Patients With Arimidex 1 mg as Adjuvant Therapy
- ClinicalTrials.gov ID
- NCT00859560
- Acronym / sponsor ID
- NIS-OJP-ARI-2007/1
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, post-menopausal women, Arimidex, bone fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,205 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Mar 2009 (estimated)
- 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.
The retrospective survey is to investigate the incidence of bone fracture in post-menopausal breast cancer patients with Arimidex 1mg, who were previously registered for the clinical experience investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Post-menoposal breast cancer patients who were previousely registered in clinical experience investigation with Arimidex 1mg as adjuvant therapy.
Key inclusion criteria (1 listed)
- Post-menopausal breast cancer patients treated with Arimidex 1mg at the time of previously conducted clinical experience investigation.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone fracture incidence
Time frame: Time since starting Arimidex
2 secondary outcomes
Survival
Time frame: Time since starting Arimidex
Bone density measurement
Time frame: Time since starting Arimidex
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 11 Mar 2009.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
AstraZeneca Japan Medical Director MD study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by AstraZeneca.
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 1 inclusion and 1 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 11 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
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 fracture incidence (time frame: Time since starting Arimidex). 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 11 Mar 2009.