- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00609830
GIOP Prevention Among People With Rheumatoid Arthritis
Osteoporosis Prevention Among People With Rheumatoid Arthritis Receiving Oral Glucocorticoid Therapy
The ultimate objective of the proposed research is to improve the health-related quality of life of individuals with rheumatoid arthritis by reducing their risk of developing osteoporosis secondary to glucocorticoid therapy. The study has four specific aims.
Specific Aim 1: To obtain descriptive information concerning patients' knowledge, beliefs and behaviors with respect to osteoporosis and osteoporosis prevention.
Specific Aim 2: To identify factors that discriminate among patients in different stages of change with respect to each behavior of interest.
Specific Aim 3: To compare the effects of tailored versus generic educational materials on patient adherence to the ACR Guidelines for the Prevention of Glucocorticoid-Induced Osteoporosis.
Specific Aim 4: To determine if the effects of tailored educational materials are enhanced by concurrent feedback of information concerning patients' behavioral risk factor status to their physicians.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599-7360
- University of North Carolina at Chapel Hill School of Pharmacy
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Meet American College of Rheumatology criteria for rheumatoid arthritis
- Taking an oral glucocorticoid equivalent to 5 mg/day of prednisone for at least one month prior to study entry
- Age 18 or older
Exclusion Criteria:
- Existing osteoporosis
- Pregnancy
- Breast feeding
- History of breast cancer
- Physician recommendation to limit calcium intake
- Class IV rheumatoid arthritis
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Tailored Materials
|
Participants received written educational materials concerning each behavior targeted.
The materials were tailored to the participants' stage of change with respect to each behavior.
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Eksperimentel: Physician Feedback
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Participants received written educational materials concerning each behavior targeted.
The materials were tailored to the participant's stage of change with respect to each behavior.
In additon, the participant's physician received information concerning the participant's status on each behavior targeted.
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Aktiv komparator: Generic Materials
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Participants received generic written educational materials about osteoporosis prevention.
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Placebo komparator: Placebo Comparator
Participants receive no information
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Participants received no informational materials.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Calcium Intake
Tidsramme: One Year
|
One Year
|
Vitamin D Intake
Tidsramme: One Year
|
One Year
|
Bone Mineral Density Testing
Tidsramme: One Year
|
One Year
|
Use of prophylactic medications (e.g., bisphosphonates)
Tidsramme: One Year
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One Year
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Susan J. Blalock, PhD, University of North Carolina, Chapel Hill
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Arthritis Foundation
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Kliniske forsøg med Rheumatoid arthritis
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Janssen Research & Development, LLCTrukket tilbageAktiv reumatoid arthritis; Rheumatoid arthritis
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Hamad Medical CorporationUkendtRHEUMATOID ARTHRITISQatar
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Richard Burt, MDAfsluttet
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Healthcare Homoeo Charitable SocietyUkendtRheumatoid arthritis.Indien
-
Federal University of São PauloAfsluttetRheumatoid arthritis.Brasilien
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloUkendt- Rheumatoid arthritisBrasilien
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Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
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Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
-
University of SalfordAfsluttetRheumatoid arthritis | Håndslidgigt | Inflammatorisk arthritisDet Forenede Kongerige
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Link America, Inc.AfsluttetSlidgigt | Rheumatoid arthritis | Post-traumatisk arthritisForenede Stater
Kliniske forsøg med Tailored Materials
-
Kirsehir Ahi Evran UniversityAfsluttet
-
Duke UniversityNational Institute of Mental Health (NIMH)AfsluttetSkizofrenispektrum og andre psykotiske lidelser | Psykiske lidelser, alvorligeTanzania
-
Manhattan Beach OrthodonticsAfsluttetSøvnapnø | OSAForenede Stater
-
Virginia Commonwealth UniversityRekruttering
-
Aydin Adnan Menderes UniversityAfsluttet