- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00173693
What is the Best Policy to Prevent Osteoporotic Fracture?
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This study aims to conduct a cost-effectiveness analysis (CEA) among the programs for preventing osteoporotic fracture. The main comparison will be made among the effects of three programs for preventing osteoporotic fractures: 1. health education; 2. exercise intervention for enhancing bone mineral density (BMD); 3. exercise intervention for preventing falls. The "cost" will be measured bases on the monetary cost of implementation of each program. The "effectiveness" will be measured includes the number of prevented osteoporotic fractures of each program, and related outcomes are the follows: 1. the medical cost of osteoporotic fracture; 2. the change of BMD in consecutive years; 3. the quality of life (QOL) of patients with osteoporotic fracture as compared to the reference population.
First year (2006): mainly a preparation stage
- To conduct a meta-analysis of the effects of various interventions of prevention of osteoporotic fracture, especially in exercise models.
- To establish the exercise programs for the intervention in the 2nd year, including the booklets and the posters.
- To review the other alternatives of prevention of osteoporotic fracture.
- To establish the social network needed for the following research. Second year (2007): to start the community-based field studies in Neihu District, Taipei.
All 37 "Lis" in Neihu will be invited to join the study, but only the Lis with willingness of participation will be the units for cluster sampling, and will be randomized to the three programs (Li as a unit). People living in the sampled Lis meet the inclusion criteria (postmenopausal (minimum for 1year) women and men over 65 years old) will be recruited and they will be further randomized into intervention group or reference group within each program.
1.To collect the baseline data. Baseline data include: the BMD, physical activity, nutrition diary, muscle strength, balance, risk factors of osteoporosis, history of fractures and falls 2.To execute the interventions. Three programs will be executed in the sampled Lis. They are all designed as a randomized control trial.
- Health education (HE trial): lectures on knowledge of osteoporosis, osteoporotic fracture, the risk factors, the nutritional demand, the exercise principles for enhancing BMD and preventing fall.
- Intervention for enhancing BMD (BMD trial): interventions to emphasize on weight-bearing exercise and trunk stabilization exercises. The exercise program will be supervised by a professional physical therapist 3 times per week for 3 months.
Intervention for preventing falls (fall prevention trial): interventions to emphasize on balance and strength training exercises. The exercise program will be also supervised by a professional physical therapist 3 times per week for 3 months.
3.To apply the NHRI released health insurance data (2002-2006) for the next year study Third year (2008): follow-up, cost calculation and study on medical cost
- To calculate the cost of three intervention programs (from the view of provider).
- Telephone follow-up (FU) and recording the incidence of fall & fracture every 3 months.
- The first FU (1st FU) of the items collected at baseline.
- To study the medical cost of osteoporotic fracture with NHRI data. Fourth year (2009): continuing follow-up and study on QOL
- Continuing the telephone FU and recording the incidence of fall & fracture every 3 months
- The second FU (2nd FU) of the items collected at baseline
- To conduct a survey for the health-related QOL of people with osteoporotic fracture from outpatient clinics in hospital and the newly fractured subjects in the community.
Fifth year (2010): continuing follow-up and CEA
- Continuing the telephone FU and recording the incidence of fall & fracture every 3 months.
- The third FU (3rd F/U) of the items collected at baseline.
- To investigate the effects of each intervention program
Type d'étude
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Taipei, Taïwan, 100
- National Taiwan University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- post menopausal women or male over 65 y/o
Exclusion Criteria:
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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Bone mineral density, osteoporotic fracture
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Mesures de résultats secondaires
Mesure des résultats |
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CEA, Osteoporosis, Fracture, Prevention, Exercise
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 9461700347
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