- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00226031
Optimal Management of Women With Wrist Fractures
Optimal Management of Older Women With Distal Forearm Fractures
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Numerous studies have demonstrated that women with wrist fractures have lower bone mineral density. Despite new guidelines for the care of such women, research has shown that they are not generally evaluated for osteoporosis. This care gap exists although it is known that wrist fractures are an important marker for subsequent fractures, such as a hip fracture, which represents a significant socio-economic burden to society.
Comparison: Cluster randomized trial of women and their physicians, both of whom receive educational material and reminder on post fracture osteoporosis evaluation. Comparison is to women and their physicians who receive standard post fracture information. Family practices are randomized to intervention or non-intervention group.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 3N6
- Queen's University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Postmenopausal women with low trauma distal radius fracture (confirmed by x-ray).
- Can be taking Didrocal (etidronate), Miacalcin (calcitonin),or hormone replacement therapy .
Exclusion Criteria:
- Women with fractures of the elbow, mid radius, scaphoid, or injury to wrists (without actual fracture).
- Significant cognitive impairment (which would preclude them from filling out simple questionnaires).
- Women already taking osteoporosis therapy, ie. either Fosamax (alendronate), Actonel (risedronate), or the selective estrogen receptor modulator, Evista (raloxifene).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 1
Usual care.
|
Family practices were randomly assigned to intervention or usual care.
The intervention was a mailed reminder with a summary of osteoporosis screening and treatment guidelines sent to the GP and a letter and educational package for the women.
|
|
Eksperimentel: 2
Mailed reminder with a summary of osteoporosis screening and treatment guidelines sent to the family physician and a letter and educational package for the women.
|
Family practices were randomly assigned to intervention or usual care.
The intervention was a mailed reminder with a summary of osteoporosis screening and treatment guidelines sent to the GP and a letter and educational package for the women.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion of women who are prescribed anti-osteoporosis therapy within 6 months of sustaining a forearm fracture.
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion of women in whom a bone density scan is ordered and the proportion of women who receive counseling advice about osteoporosis from their family physicians.
Tidsramme: 6 months
|
6 months
|
|
Women's knowledge about osteoporosis and fractures (Osteoporosis Knowledge Questionnaire).
Tidsramme: 6 months
|
6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ann B Cranney, MD, Queen's University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
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
- KTS-62358
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