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Fluoride Bone Cancer 7

Fluoride Bone Cancer 7

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Published by: mary eng on Apr 28, 2013
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04/28/2013

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PERIOD COVERED SV THIS REPORTFROM THROUGH
PROGRESS REPORT SUMMARY
PRINCIPAL INVESTIGATOR OR PROGRAM DIRECTOR
Chest er W. Dougl ass
APPLICANT ORGANIZATION
Har var d School of Dent al Medi ci ne
 TITLE OF PROJECT
(Repeat title shown in item
1
on first page)
Fl uor i de Exposur e and Ost eosar coma
(SEE INSTRUCTIONS)
PROGRESS REPORT SUMMARY
'\NT NUMBER
ES06000; . . . 039/ 30/ 93
9/ 29/ 94
1. Speci fi cAi ms The Nati onal Toxi col ogy program (NTP) found Dl equi vocalevi dence" of carci nogeni ci ty based on the occurrence of a smal lnumber osteosarcomas i n mal e rats fed doses of hi ghl y fl uori datedwater!. A subcommi ttee of the Commi ttee to Coordi nate Envi ronmentalHeal th and Rel ated programs (CCEHRP) was then convened te anal yzebenefi ts and ri sks of fl uori de i n dri nki ng water.An anal ysi s of 12 "fl uori datedUl counti es and 21 "non-fl uori dated" counti es wi thi n two SEER si tes used as a basi s for theCCEHRP Fi nal Report that di rectl y refuted the NTP fi ndi ngs
2
Thi sstudy measured the exposure of i nterest, i ngesti on of fl uori datedwater, onl y at the county l evel , and no attempt was made to capturethe effect of mi grati on. To achi eve the ori gi nal goal of theCommi ttee, thi s nati on-wi de hospi tal -based case-control study wi l lprovi de a more sci enti fi cal l y concl usi ve assessment of ri sk forosteosarcoma from i ngesti on of fl uori dated water. Speci fi e ai msaddressed i n the on-goi ng study i ncl ude:1. To compare the compl ete resi denti al fl uor i de hi stori es oosteosarcoma pati ents (both preval ent and i nci dent cases) wi th thefl uor i de hi stori es of hospi tal -based controI s.2. To compare total fl uori de exposure fromoral hygi ene practi cesbetween cases and controI s; i ncl udi ng fl uor i de suppl ements, seI f-appl i ed and professi onal l y appl i ed topi cal fl uor i des, andparti ci pati on i n school based fl uori de programs.3. To compare fl uor i de content i n bone andosteosarcoma pati ents wi th the fl uori de contenttoenai l s of hospi tal based control s.toenai l si n bone
of 
and4. To control for age, gender, and educati on i n the compari son ocases and control s.2. STUDI ES AND RESULTS To accompl i sh these ai ms, a retrospecti ve and prospecti vehospi tal based case-control study was proposed and i mpl emented
PHS 2590 (Rev.
9/91)
(Form Page 6) Page ~
(Use continuation pages
if 
necessaryi
 
i
ES06000-03
duri ng the fi rst year. The retrospeeti ve aspect of the casecontrol study col l ected data from preval ent cases and control s seenat 10 hospi taI s nati on-wi de. Cases are defi ned as pati entsdi agnosed wi th pri mary osteosarcoma from 11-01-89 to 12-31-92 bythe parti ci pati ng orthopedi e surgeons. Non-cancerous control smatched by age, gender, and di stance from the hospi tal were chosenfrom the i n- and out- pati ent rosters of each of the hospi tal s'surgery department. A 1: 2 rati o of cases to control s was enrol l ed. The fol l owi ng hospi tal s provi ded access to the pati entsenrol l ed as a case or control i n the retrospecti ve aspect of thestudy:Hospi talMassachusetts General Hospi tal# of Preval ent Cases/ Control s#Cases #Control s Total s
45 90 135
Chi l dren' s Hospi tal - BostonCrei ghton Uni versi tyChi l dren' s Hospi tal - DCMemori al Sl oan Ketteri ngUni versi ty of Chi cagoRush Medi cal Col l egeUni versi ty of Fl ori daUCLACase Western/ Cl evel and Cl i ni c
18
9
19
27
21
13
27
29
18
226
36
18
38
5442265458
36
452
5427
5781
63
39
81
87
54
678
Osteosarcoma pati ents and the matched contraI s wi th anypredi agnosi s hi story of the known ri sk factor, radi ati on therapy,are excl uded. l n addi ti on, pati ents wi th a hi story of ki dneydi al ysi s are excl uded as they chose to dri nk dei oni zed water formedi cal reasons. Both genders and aI l races are i ncl uded forstudy.Protocol and Data Col l ecti on for the Retrospecti ve Study The proj ect Di rector, Dr. McGui re, travel ed te each hospi talto revi ew medi cal records and determi ne the el i gi bi l i ty of the
40
 
ES06000-03
preval ent cases. Once the age at di agnosi s, gender, and di stancefromthe hospi tal was transcri bed fromeach el i gi bl e case medi calrecord, the process to chose the correspondi ng control s was begun.Each hospi tal (except for Chi l dren' s of DC ) had the capabi l i ty togenerate a computer pri ntout of the i n-andfor out-pati ent rosters.A l i sti ng of the pati ents matchi ng the age
(+
5 years), gender anddi stance from the hospi tal of each of the cases was requested.Once the l i sti ng was recei ved, si x names were sel ected at randomand thei r medi cal records were ordered so that abstracti on odemographi c and medi cal i nformati on coul d be compl eted. More thanone return tri p to each hospi tal was necessary to retri eve thei nformati on from the medi cal records of the qual i fyi ng matchedcontrol s because of the ti meframe needed to generate the roster andorder the medi cal records. The i nformati on abstracted by Dr. McGui re from the medi calrecords of the el i gi bl ecases and the qual i fi ed control s wasentered di rectl y i nto a software program devel oped by New Engl andResearch I nsti tute (NERI ). The data were then downl oaded onto di sksand mai l ed to NERI . Researchers at NERI proceeded te send a l etterof expl anati on of the research goal s of the study to the el i gi bl eosteosarcoma pati ents and the qual i fi ed matched control s. Tel ephonecontact fol l owed wi thi n
la
days for the admi ni strati on of thetel ephone questi onnai re (See Appendi x A for the retrospecti vequesti onnai re). A parent was surveyed i f the case/ control was l essthan 18 years ol d. Appendi x B reports the status of thedi sposi ti ons for the compl eti on of data col l ecti on from thepreval ent cases and control s as of the end of the Thi rd Quarter
(6/30/94)
Di sposi ti ons are fi nal for aI l but three percent(22/ 678) of the parti ci pants. We have yet to obtai n weI l watersampl es for these remai ni ng 22 parti ci pants. The l ast remi ndertel ephone cal I was made i n J une to el i ci t the remai ni ng sampl es.Approxi matel y 25 percent of the cases and control s used weI lwater at some poi nt i n thei r resi denti al hi story. Thi s rate washi gher than expected duri ng the pi l ot phase. Harvard School oDental Medi ci ne proj ect staff sent l etters and vi al s for weI l watersarnpl ecol l ecti on to the cases/ control s who reported weI l wateruse. The parti ci pants are provi ded wi th a postage pai d cardboardcontai ner i n whi ch to return the weI l water sampl e. Dr. McGui remeasures the l evel of fl uori de i n each sampl e wi th the use of a DR
100
Col ori meter.Expanded Data Col l ecti on i n the Prospecti ve studyDuri ng Year 1, arrangements had been made to coordi nate thestudy wi th an expanded data col l ecti on effort of the eti ol ogy oosteosarcoma whi ch wi l l be conducted by the Nati onal Cancer
41

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