Endometrial CancerNCT00340262
Bone Mineral Density and Subsequent Cancer Risk
An observational study of Endometrial Cancer and Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Recent cohort studies demonstrated reduced breast cancer risks among women with a history of fractures or low bone mineral density (BMD). In the Study of Osteoporotic Fractures, each standard deviation increase in distal radius BMD was associated with a 50% increased risk over three years of follow-up, while in the… Read more about this study
- Who is it for?
- Ages 55 to 80 years, women only
- Conditions the study is for
- Endometrial Cancer, Breast Cancer
- How many people
- 15,595 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2000to 26 Mar 2020
- 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 55 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The B FIT study included 15,595 of the 22,695 who were screened for participation in the Fracture Intervention Trial (FIT), a randomized clinical trial originally designed to test whether alendronate, a bispohosphonate, would reduce the rate of fractures in women with low bone mineral density (Black et al. 1993). The FIT clinical trial (1992-1998) enrolled approximately 6000 volunteers who had low BMD. The B FIT follow-up study includes all women (regardless of baseline BMD) who volunteered for FIT. In 1992-1993, postmenopausal women (ages 55-80) completed an extensive questionnaire, donated a baseline blood sample, underwent a bone mineral density scan, and provided clinical examination data. As part of the B FIT study, these women were followed (median 10.3 years) to ascertain incident cancer outcomes and incident fractures through the period of 2001-2004.
Who may be able to join
- Women previously enrolled in FIT and provided informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Recent cohort studies demonstrated reduced breast cancer risks among women with a history of fractures or low bone mineral density (BMD). In the Study of Osteoporotic Fractures, each standard deviation increase in distal radius BMD was associated with a 50% increased risk over three years of follow-up, while in the Framingham study, women in the highest quartile of metacarpal bone mass had a 3.5-fold higher risk than women in the lowest quartile. The impact of the severity and timing of bone loss on risk has not yet been investigated, and the extent to which other risk factors (family history, anthropometric factors, physical activity, and exogenous hormones) modify the relationship with BMD is unknown.
To elaborate on these research questions, we are conducting a follow-up study of 22,695 postmenopausal women who volunteered for the Fracture Intervention Trial (FIT), a trial of the bone-enhancing drug alendronate. This large cohort includes extensive baseline information on major breast cancer risk factors, and thus is ideal for evaluating potential interactions with BMD and the effects of BMD on other cancer sites. Endometrial cancer has been reported to occur more frequently among women with a history of fracture, but no previous studies have specifically investigated its relationship to BMD.
Read more
We are investigating whether BMD of the proximal femur predicts breast cancer risk; whether breast cancer risk factors among postmenopausal women modify the relationship with BMD; whether BMD predicts endometrial or other cancers; and whether measurable biomarkers offer further etiologic clues about BMD and cancer risk.
We have contacted the surviving members of FIT to ascertain incident cancers. Risk factors and fracture history are being updated through a self-administered questionnaire. To supplement the serum samples collected at baseline, we are using a nested case-control study approach to collect buccal cell specimens, which may be useful for measuring a variety of biomarkers, including endogenous hormones and genetic polymorphisms involved in either bone growth (e.g., vitamin D receptor) or hormone metabolism (e.g., CYP17, COMT). Retrieval of operative and pathology reports is being used to validate self-reported cancers. The social security numbers and contacts names provided by FIT participants when they completed the baseline questionnaire are facilitating comprehensive follow-up and a National Death Index search for those who cannot be located. The baseline data, the established cooperation of this study population, and the collection of additional biospecimens should enable this study to answer important questions about BMD in breast and endometrial cancers.
Read the detailed description
Recent cohort studies demonstrated reduced breast cancer risks among women with a history of fractures or low bone mineral density (BMD). In the Study of Osteoporotic Fractures, each standard deviation increase in distal radius BMD was associated with a 50% increased risk over three years of follow-up, while in the Framingham study, women in the highest quartile of metacarpal bone mass had a 3.5-fold higher risk than women in the lowest quartile. The impact of the severity and timing of bone loss on risk has not been investigated, and the extent to which other risk factors (family history, lifestyle, and exogenous hormones) modify the relationship with BMD is unknown.
To elaborate on these research questions, we conducted a follow-up study of postmenopausal women who volunteered for the Fracture Intervention Trial (FIT), a trial of the bone-enhancing drug alendronate. The BFIT follow-up study includes 15,595 of the 22,695 FIT volunteers. Surviving members of FIT were contacted to ascertain incident cancers and to provide updated risk factor and fracture history through a self-administered questionnaire. To supplement baseline serum samples, we used a nested case-control approach to collect buccal cell specimens for biomarker measurement, including endogenous hormones and genetic polymorphisms involved in either bone growth (e.g., vitamin D receptor) or hormone metabolism (e.g., CYPI7, COMT). Operative and pathology reports were used to validate self-reported cancers. The social security numbers and contact names provided by FIT participants at baseline facilitated comprehensive follow-up and a National Death Index search for those who could not be located.
This large cohort includes extensive baseline information on major breast cancer risk factors, and thus is ideal for evaluating potential interactions with BMD and the effects of BMD on other cancer sites. Endometrial cancer has been reported to occur more frequently among women with a history of fracture, but no previous studies have investigated its relationship to BMD. We are investigating whether proximal femur BMD predicts breast cancer risk; whether breast cancer risk factors among postmenopausal women modify the relationship with BMD; whether BMD predicts cancer risk; and whether biomarkers offer etiologic clues about BMD and cancer risk. Currently, we are examining: 1) the relationship of serum adipocytokines to endometrial cancer risk, and 2) the relationships of serum estrogens and metabolites to postmenopausal breast cancer risk. The baseline and follow-up data and the collection of additional biospecimens should enable us to answer important questions about BMD and other cancers.
- Conditions
- Endometrial Cancer, Breast Cancer
- Keywords
- Supplemental Hormone Use, Osteoporosis, Endogenous Sex Hormones
- Medical subject headings
- Endometrial Neoplasms, Breast Neoplasms, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FIT Participants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident cancer diagnosis
breast, endometrial, ovarian, colorectal
Measured: Through December 2003
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start7 Apr 2000
- Primary completion31 Dec 2004
- Study completion26 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Prospective
- Enrolment
- 15,595 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Britton L Trabert, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340262
- Sponsor's protocol ID
- 999900019
- Other IDs
- OH00-C-N019
- Status last verified
- Mar 2020
- First submitted
- 19 Jun 2006
- Last updated
- 30 Mar 2020
- Results posted
- No
Publications
Kuller LH, Cauley JA, Lucas L, Cummings S, Browner WS. Sex steroid hormones, bone mineral density, and risk of breast cancer. Environ Health Perspect. 1997 Apr;105 Suppl 3(Suppl 3):593-9. doi: 10.1289/ehp.97105s3593.
PubMed 9168001Newcomb PA, Trentham-Dietz A, Egan KM, Titus-Ernstoff L, Baron JA, Storer BE, Willett WC, Stampfer MJ. Fracture history and risk of breast and endometrial cancer. Am J Epidemiol. 2001 Jun 1;153(11):1071-8. doi: 10.1093/aje/153.11.1071.
PubMed 11390325
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Mineral Density and Subsequent Cancer Risk
- ClinicalTrials.gov ID
- NCT00340262
- Acronym / sponsor ID
- 999900019
- Conditions
- Endometrial Cancer, Breast Cancer
- Keywords
- Supplemental Hormone Use, Osteoporosis, Endogenous Sex Hormones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,595 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 7 Apr 2000 (actual)
- Primary completion
- 31 Dec 2004 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 21 Jun 2006 (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.
Recent cohort studies demonstrated reduced breast cancer risks among women with a history of fractures or low bone mineral density (BMD). In the Study of Osteoporotic Fractures, each standard deviation increase in distal radius BMD was associated with a 50% increased risk over three years of follow-up, while in the Framingham study, women in the highest quartile of metacarpal bone mass had a 3.5-fold higher risk than women in the lowest quartile. The impact of the severity and timing of bone loss on risk has not yet been investigated, and the extent to which other risk factors (family history, anthropometric factors, physical activity, and exogenous hormones) modify the relationship with BMD is unknown.
To elaborate on these research questions, we are conducting a follow-up study of 22,695 postmenopausal women who volunteered for the Fracture Intervention Trial (FIT), a trial of the bone-enhancing drug alendronate. This large cohort includes extensive baseline information on major breast cancer risk factors, and thus is ideal for evaluating potential interactions with BMD and the effects of BMD on other cancer sites. Endometrial cancer has been reported to occur more frequently among women with a history of fracture, but no previous studies have specifically investigated its relationship to BMD.
We are investigating whether BMD of the proximal femur predicts breast cancer risk; whether breast cancer risk factors among postmenopausal women modify the relationship with BMD; whether BMD predicts endometrial or other cancers; and whether measurable biomarkers offer further etiologic clues about BMD and cancer risk.
We have contacted the surviving members of FIT to ascertain incident cancers. Risk factors and fracture history are being updated through a self-administered questionnaire. To supplement the serum samples collected at baseline, we are using a nested case-control study approach to collect buccal cell specimens, which may be useful for measuring a variety of biomarkers, including endogenous hormones and genetic polymorphisms involved in either bone growth (e.g., vitamin D receptor) or hormone metabolism (e.g., CYP17, COMT). Retrieval of operative and pathology reports is being used to validate self-reported cancers. The social security numbers and contacts names provided by FIT participants when they completed the baseline questionnaire are facilitating comprehensive follow-up and a National Death Index search for those who cannot be located. The baseline data, the established cooperation of this study population, and the collection of additional biospecimens should enable this study to answer important questions about BMD in breast and endometrial cancers.
Detailed description
Recent cohort studies demonstrated reduced breast cancer risks among women with a history of fractures or low bone mineral density (BMD). In the Study of Osteoporotic Fractures, each standard deviation increase in distal radius BMD was associated with a 50% increased risk over three years of follow-up, while in the Framingham study, women in the highest quartile of metacarpal bone mass had a 3.5-fold higher risk than women in the lowest quartile. The impact of the severity and timing of bone loss on risk has not been investigated, and the extent to which other risk factors (family history, lifestyle, and exogenous hormones) modify the relationship with BMD is unknown.
To elaborate on these research questions, we conducted a follow-up study of postmenopausal women who volunteered for the Fracture Intervention Trial (FIT), a trial of the bone-enhancing drug alendronate. The BFIT follow-up study includes 15,595 of the 22,695 FIT volunteers. Surviving members of FIT were contacted to ascertain incident cancers and to provide updated risk factor and fracture history through a self-administered questionnaire. To supplement baseline serum samples, we used a nested case-control approach to collect buccal cell specimens for biomarker measurement, including endogenous hormones and genetic polymorphisms involved in either bone growth (e.g., vitamin D receptor) or hormone metabolism (e.g., CYPI7, COMT). Operative and pathology reports were used to validate self-reported cancers. The social security numbers and contact names provided by FIT participants at baseline facilitated comprehensive follow-up and a National Death Index search for those who could not be located.
This large cohort includes extensive baseline information on major breast cancer risk factors, and thus is ideal for evaluating potential interactions with BMD and the effects of BMD on other cancer sites. Endometrial cancer has been reported to occur more frequently among women with a history of fracture, but no previous studies have investigated its relationship to BMD. We are investigating whether proximal femur BMD predicts breast cancer risk; whether breast cancer risk factors among postmenopausal women modify the relationship with BMD; whether BMD predicts cancer risk; and whether biomarkers offer etiologic clues about BMD and cancer risk. Currently, we are examining: 1) the relationship of serum adipocytokines to endometrial cancer risk, and 2) the relationships of serum estrogens and metabolites to postmenopausal breast cancer risk. The baseline and follow-up data and the collection of additional biospecimens should enable us to answer important questions about BMD and other cancers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FIT Participants | – | – |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The B FIT study included 15,595 of the 22,695 who were screened for participation in the Fracture Intervention Trial (FIT), a randomized clinical trial originally designed to test whether alendronate, a bispohosphonate, would reduce the rate of fractures in women with low bone mineral density (Black et al. 1993). The FIT clinical trial (1992-1998) enrolled approximately 6000 volunteers who had low BMD. The B FIT follow-up study includes all women (regardless of baseline BMD) who volunteered for FIT. In 1992-1993, postmenopausal women (ages 55-80) completed an extensive questionnaire, donated a baseline blood sample, underwent a bone mineral density scan, and provided clinical examination data. As part of the B FIT study, these women were followed (median 10.3 years) to ascertain incident cancer outcomes and incident fractures through the period of 2001-2004.
Key inclusion criteria (1 listed)
- Women previously enrolled in FIT and provided informed consent.
Key exclusion criteria (0 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
Incident cancer diagnosis
Time frame: Through December 2003
breast, endometrial, ovarian, colorectal
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 30 Mar 2020.
- Background: PubMed 9168001Kuller LH, Cauley JA, Lucas L, Cummings S, Browner WS. Sex steroid hormones, bone mineral density, and risk of breast cancer. Environ Health Perspect. 1997 Apr;105 Suppl 3(Suppl 3):593-9. doi: 10.1289/ehp.97105s3593.
- Background: PubMed 11390325Newcomb PA, Trentham-Dietz A, Egan KM, Titus-Ernstoff L, Baron JA, Storer BE, Willett WC, Stampfer MJ. Fracture history and risk of breast and endometrial cancer. Am J Epidemiol. 2001 Jun 1;153(11):1071-8. doi: 10.1093/aje/153.11.1071.
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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.
Britton L Trabert, Ph.D. principal investigator
National Cancer Institute (NCI)
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 Endometrial Cancer and Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
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 0 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 30 Mar 2020. 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 United States. 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?
Incident cancer diagnosis (time frame: Through December 2003). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00340262, which also lists 2 linked publications.
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 30 Mar 2020.