- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00046137
Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis
19. juli 2006 opdateret af: Eli Lilly and Company
The purpose of this study is to compare treatment with both teriparatide and raloxifene with teriparatide alone.
The study will evaluate any side effects that may be associated with the two drugs and may help to determine whether teriparatide and raloxifene together can help patients with osteoporosis more than teriparatide alone.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Anaheim, California, Forenede Stater, 92801
- "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
-
Oakland, California, Forenede Stater, 94612
- "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
-
-
Florida
-
Altamonte Springs, Florida, Forenede Stater, 32714
- "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60622
- "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
-
-
Iowa
-
Cedar Rapids, Iowa, Forenede Stater, 52401
- "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21204
- "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
-
Hagerstown, Maryland, Forenede Stater, 21740
- "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
-
-
New Jersey
-
Voorhees, New Jersey, Forenede Stater, 08043
- "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44195
- "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73109
- "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97213
- "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
-
-
Pennsylvania
-
Duncansville, Pennsylvania, Forenede Stater, 16635
- "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75231
- "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician".
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
45 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria
- Must be diagnosed with osteoporosis.
- Must be female, age 45 through 85.
- Must be at least 5 years postmenopausal.
- Must be free of other severe or chronically disabling conditions.
- Must be able to properly use injection device.
Exclusion Criteria
- Must not have bone diseases other than osteoporosis.
- Must not have history of certain cancers.
- Must not have certain medical diseases (inflammatory bowel disease, malabsorption syndrome, kidney or bladder stones, venous thrombi or emboli, recent vaginal bleeding due to unknown causes).
- Must not have taken or are currently taking certain types of medicines.
- Must not have known allergy to the study agent or SERM.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Datoer for studieregistrering
Først indsendt
20. september 2002
Først indsendt, der opfyldte QC-kriterier
20. september 2002
Først opslået (Skøn)
23. september 2002
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. juli 2006
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. juli 2006
Sidst verificeret
1. juli 2006
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Metaboliske sygdomme
- Muskuloskeletale sygdomme
- Knoglesygdomme
- Knoglesygdomme, metaboliske
- Osteoporose
- Osteoporose, postmenopausal
- Lægemidlers fysiologiske virkninger
- Hormoner, hormonsubstitutter og hormonantagonister
- Hormonantagonister
- Knogletæthedsbevarende midler
- Calciumregulerende hormoner og midler
- Østrogenantagonister
- Selektive østrogenreceptormodulatorer
- Østrogenreceptormodulatorer
- Raloxifen hydrochlorid
- Teriparatid
Andre undersøgelses-id-numre
- 6817
- B3D-MC-GHCD
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .