- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01224678
Vitamin D and Breast Cancer Biomarkers in Female Patients
Vitamin D and Breast Cancer Biomarkers
RATIONALE: Vitamin D may help prevent breast cancer.
PURPOSE: This randomized clinical trial is studying vitamin D and breast cancer biomarkers in female patients.
Studieoversikt
Detaljert beskrivelse
OBJECTIVES:
Primary
- To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women.
Secondary
- To explore changes in the serum biomarker IGF1 in response to one year of vitamin D or placebo supplementation in premenopausal women.
- To explore changes in cellular proliferation (atypia and Ki67) in response to one year of vitamin D or placebo supplementation in premenopausal women.
- To explore correlations between change in breast cancer biomarkers (density, IGF1, atypia, and Ki67) with each other and with change in vitamin D levels.
- To compare methods of mammographic density analysis.
- To validate a recently developed sunlight questionnaire.
OUTLINE: This is a multicenter study. Patients are stratified according to baseline vitamin D (sufficient [≥ 30 ng/mL or ≥ 75 mmol/L] vs insufficient [< 30 ng/mL or < 75 mmol/L]) and institutional random periareolar fine-needle aspiration (RPFNA) status (performs RPFNA vs does not perform RPFNA). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral placebo once daily for 12 months.
- Arm II: Patients receive oral vitamin D (2000 IU) once daily for 12 months. Tissue and blood samples are collected at baseline and at 12 months for laboratory biomarker analysis. Patients also complete questionnaires at baseline and at 12 months.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Alabama
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Anniston, Alabama, Forente stater, 36207
- Regional Medical Center
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California
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Martinez, California, Forente stater, 94553-3156
- Contra Costa Regional Medical Center
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Mountain View, California, Forente stater, 94040
- El Camino Hospital Cancer Center
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Mountain View, California, Forente stater, 94040
- Camino Medical Group - Treatment Center
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Oakland, California, Forente stater, 94609
- Larry G Strieff MD Medical Corporation
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Oakland, California, Forente stater, 94609
- CCOP - Bay Area Tumor Institute
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Oakland, California, Forente stater, 94609
- Bay Area Breast Surgeons, Incorporated
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Oakland, California, Forente stater, 94609
- Tom K Lee, Incorporated
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Palo Alto, California, Forente stater, 94301
- Palo Alto Medical Foundation
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Pismo Beach, California, Forente stater, 93449
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San Pablo, California, Forente stater, 94806
- Doctors Medical Center - San Pablo Campus
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Connecticut
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Greenwich, Connecticut, Forente stater, 06830
- Bendheim Cancer Center at Greenwich Hospital
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Florida
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Fort Lauderdale, Florida, Forente stater, 33308
- Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
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Jupiter, Florida, Forente stater, 33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Miami Beach, Florida, Forente stater, 33140
- CCOP - Mount Sinai Medical Center
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Orlando, Florida, Forente stater, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Illinois
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Bloomington, Illinois, Forente stater, 61701
- Illinois CancerCare - Bloomington
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Bloomington, Illinois, Forente stater, 61701
- St. Joseph Medical Center
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Canton, Illinois, Forente stater, 61520
- Illinois CancerCare - Canton
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Chicago, Illinois, Forente stater, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Forente stater, 60640
- Louis A. Weiss Memorial Hospital
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Eureka, Illinois, Forente stater, 61530
- Illinois CancerCare - Eureka
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Eureka, Illinois, Forente stater, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Forente stater, 61401
- Galesburg Clinic, PC
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Macomb, Illinois, Forente stater, 61455
- Illinois CancerCare - Macomb
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Macomb, Illinois, Forente stater, 61455
- Mcdonough District Hospital
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Normal, Illinois, Forente stater, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Forente stater, 61761
- Community Cancer Center
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Normal, Illinois, Forente stater, 61761
- Illinois CancerCare - Community Cancer Center
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Ottawa, Illinois, Forente stater, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Forente stater, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Forente stater, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, Forente stater, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, Forente stater, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Forente stater, 61614
- Proctor Hospital
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Peoria, Illinois, Forente stater, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Forente stater, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Forente stater, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Forente stater, 61354
- Illinois CancerCare - Peru
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Peru, Illinois, Forente stater, 61354
- Illinois Valley Community Hospital
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Spring Valley, Illinois, Forente stater, 61362
- Illinois CancerCare - Spring Valley
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Indiana
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Elkhart, Indiana, Forente stater, 46515
- Elkhart General Hospital
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Elkhart, Indiana, Forente stater, 46514-2098
- Elkhart Clinic, LLC
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Elkhart, Indiana, Forente stater, 46514
- Michiana Hematology-Oncology, PC - Elkhart
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Kokomo, Indiana, Forente stater, 46904
- Howard Community Hospital
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La Porte, Indiana, Forente stater, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Mishawaka, Indiana, Forente stater, 46545-1470
- Michiana Hematology-Oncology, PC - South Bend
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Mishawaka, Indiana, Forente stater, 46545-1470
- Saint Joseph Regional Medical Center
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Plymouth, Indiana, Forente stater, 46563
- Michiana Hematology Oncology PC - Plymouth
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South Bend, Indiana, Forente stater, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Forente stater, 46601
- CCOP - Northern Indiana CR Consortium
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Westville, Indiana, Forente stater, 46391
- Michiana Hematology Oncology PC - La Porte
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Maryland
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Bethesda, Maryland, Forente stater, 20889-5600
- National Naval Medical Center
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
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Lowell, Massachusetts, Forente stater, 01854
- Lowell General Hospital
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Newton, Massachusetts, Forente stater, 02462
- Newton-Wellesley Hospital
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South Weymouth, Massachusetts, Forente stater, 02190
- Dana-Farber/Brigham and Women's Cancer Center at South Shore
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Michigan
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Battle Creek, Michigan, Forente stater, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, Forente stater, 49307
- Mecosta County Medical Center
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Grand Rapids, Michigan, Forente stater, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, Forente stater, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Forente stater, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Muskegon, Michigan, Forente stater, 49444
- Mercy General Health Partners
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Saint Joseph, Michigan, Forente stater, 49085
- Lakeside Cancer Specialists, PLLC
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Saint Joseph, Michigan, Forente stater, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Traverse City, Michigan, Forente stater, 49684
- Munson Medical Center
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Cancer Center
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Missouri
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Chesterfield, Missouri, Forente stater, 63017
- Saint Luke's Hospital
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Columbia, Missouri, Forente stater, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Nebraska
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Omaha, Nebraska, Forente stater, 68114
- Methodist Estabrook Cancer Center
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New Hampshire
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Concord, New Hampshire, Forente stater, 03301
- New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
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Hooksett, New Hampshire, Forente stater, 03106
- New Hampshire Oncology - Hematology, PA - Hooksett
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Laconia, New Hampshire, Forente stater, 03246
- Lakes Region General Hospital
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Lebanon, New Hampshire, Forente stater, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New York
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Buffalo, New York, Forente stater, 14263-0001
- Roswell Park Cancer Institute
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East Syracuse, New York, Forente stater, 13057
- CCOP - Hematology-Oncology Associates of Central New York
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Elmhurst, New York, Forente stater, 11373
- Elmhurst Hospital Center
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Glens Falls, New York, Forente stater, 12801
- Charles R. Wood Cancer Center at Glens Falls Hospital
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Jamaica, New York, Forente stater, 11432
- Queens Cancer Center of Queens Hospital
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New York, New York, Forente stater, 10029
- Mount Sinai Medical Center
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Syracuse, New York, Forente stater, 13210
- SUNY Upstate Medical University Hospital
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Utica, New York, Forente stater, 13502
- Faxton Regional Cancer Center
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North Carolina
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Charlotte, North Carolina, Forente stater, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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Durham, North Carolina, Forente stater, 27710
- Duke Cancer Institute
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Goldsboro, North Carolina, Forente stater, 27534
- Wayne Memorial Hospital, Incorporated
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Raleigh, North Carolina, Forente stater, 27614
- Rex Cancer Center of Wakefield
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Raleigh, North Carolina, Forente stater, 27607
- Rex Cancer Center at Rex Hospital
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Wilmington, North Carolina, Forente stater, 28401
- Zimmer Cancer Center at New Hanover Regional Medical Center
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Winston-Salem, North Carolina, Forente stater, 27103
- Forsyth Regional Cancer Center at Forsyth Medical Center
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Ohio
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Columbus, Ohio, Forente stater, 43210-1240
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
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Lima, Ohio, Forente stater, 45801
- St. Rita's Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
- Oklahoma University Cancer Institute
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Oklahoma City, Oklahoma, Forente stater, 73120
- Cancer Care Associates - Mercy Campus
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South Carolina
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Greenville, South Carolina, Forente stater, 29615
- CCOP - Greenville
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Greenville, South Carolina, Forente stater, 29605
- Greenville Hospital Cancer Center
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Greenville, South Carolina, Forente stater, 29605
- Cancer Centers of the Carolinas - Faris Road
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Seneca, South Carolina, Forente stater, 29672
- Cancer Centers of the Carolinas - Seneca
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Spartanburg, South Carolina, Forente stater, 29307
- Cancer Centers of the Carolinas - Spartanburg
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Tennessee
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Kingsport, Tennessee, Forente stater, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
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Texas
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Houston, Texas, Forente stater, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Laredo, Texas, Forente stater, 78045
- Doctor's Hospital of Laredo
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Vermont
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Berlin, Vermont, Forente stater, 05602
- Mountainview Medical
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Burlington, Vermont, Forente stater, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
- Premenopausal women 55 years of age or younger with regular menstrual cycles (at least four cycles in the last six months). Women with fewer than 4 menses in the last 6 months or who have had a hysterectomy with ovaries intact will be considered premenopausal if FSH level < 20.
- Women with breast density ≥ 25% (scattered fibroglandular densities or greater) are eligible.
Prior Treatment
Patients who are currently receiving hormone replacement therapy (estrogen or progesterone); or are taking tamoxifen or raloxifene are not eligible. Women who have taken these medications must have stopped for at least 4 months prior to study entry.
Topical estrogen (eg, transdermal patches and vaginal estrogens) is allowed.
- Patients who are currently using hormonal contraception, should be taking it for at least 4 months prior to study entry.
Vitamin D Use
- Patients who are taking regular vitamin D supplementation (above 400 IUs daily) and refuse or are unable to stop use are not eligible. Women who agree to stop will need to do so for at least 6 months prior to registration.
- Patients may not start vitamin D supplementation after registration (regardless of results of vitamin D testing) but they may continue vitamin D if they are already taking 400 IUs daily or less and have been taking vitamin D for at least 6 months prior to baseline mammogram.
- Patients with a history of breast cancer (including DCIS) or ovarian cancer are not eligible.
- Patients with a history of breast implants or breast reduction are not eligible.
- Patients with two or more bone fractures in the past five years are not eligible.
- Patients with a diagnosis of osteoporosis with physician recommendation for treatment of low bone mass are not eligible.
- Patients known to have hyperparathyroid disease or other serious disturbances of calcium metabolism requiring intervention in the past 5 years are not eligible.
- Patients with a history of kidney stones (unless documented not to have been a calcium stone) are not eligible.
- Patients participating in a concurrent breast cancer chemoprevention trial are not eligible.
- Required initial laboratory values - Calcium < 10.5 mg/dL
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: Placebo
Patients receive oral placebo once daily for 12 months.
|
Gis muntlig
|
Eksperimentell: Vitamin D
Patients receive oral vitamin D (2000 IU) once daily for 12 months.
|
Given orally
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms
Tidsramme: 12 months
|
To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women.
The percent change in breast density will be reported here.
|
12 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: Marie E. Wood, MD, University of Vermont
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CALGB-70806
- CDR0000687263 (Registeridentifikator: NCI Physician Data Query)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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