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NCT00340262 · ClinicalTrials.gov registry record
Bone Mineral Density and Subsequent Cancer Risk
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 15,595
- Enrollment target
NCT00340262: Completed study, sponsored by National Cancer Institute (NCI).
NCT00340262 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 15,595 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00340262 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 15,595 participants
- Enrollment target
Study 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 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
Primary Outcome
breast, endometrial, ovarian, colorectal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15,595 participants |
| Start Date | 2000-04-07 |
| Est. Completion | 2020-03-26 |
What the finished NCT00340262 record still lists
NCT00340262 is an observational study that tracks outcomes without assigning an intervention. Its 15,595 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT00340262 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00340262 about?
NCT00340262 is a clinical study titled "Bone Mineral Density and Subsequent Cancer Risk". 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-...
What is the current status of trial NCT00340262?
This trial is currently completed. The enrollment target is 15,595 participants. The study started on 2000-04-07. Estimated completion is 2020-03-26.
Who is sponsoring clinical trial NCT00340262?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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