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- Essai clinique NCT02106442
36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets
36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Benet 75 mg Tablets
Aperçu de l'étude
Description détaillée
This special drug use surveillance was designed to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change from baseline in bone density, etc.) and safety of sodium risedronate 75 mg tablets in osteoporosis patients in daily medical practice.
The usual dosage for adult is 75 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Osaka, Japon
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Tokyo, Japon
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
Osteoporosis patients who meet all the following criteria:
- Patients with 1 to 4 confirmed vertebral body fractures in the T4-L4 region by thoracic and lumbar spine X-ray examination at screening (within 3 months before the start of administration of sodium risedronate 75 mg tablets)
- Male and postmenopausal female patients aged 50 years or older
- Ambulatory outpatients
Exclusion Criteria:
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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Sodium Risedronate 75 mg
75 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking.
Participants receive sodium risedronate 75 mg as part of routine medical care.
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Sodium risedronate tablets
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
Délai: From baseline up to Month 36
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The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
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From baseline up to Month 36
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Cumulative Percentage of Participants With Non-Vertebral Body Fractures
Délai: From baseline up to Month 36
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The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
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From baseline up to Month 36
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Cumulative Percentage of Participants With Femur Fractures
Délai: From baseline up to Month 36
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The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
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From baseline up to Month 36
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Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36)
Délai: Baseline and final assessment (up to Month 36)
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BMD was measured by dual-energy X-ray absorptiometry.
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36)
Délai: Baseline and final assessment (up to Month 36)
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BMD was measured by dual-energy X-ray absorptiometry.
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36)
Délai: Baseline and final assessment (up to Month 36)
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BMD was measured by dual-energy X-ray absorptiometry.
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36)
Délai: Baseline and final assessment (up to Month 36)
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BMD was measured by dual-energy X-ray absorptiometry.
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
Délai: Baseline and final assessment (up to Month 36)
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36)
Délai: Baseline and final assessment (up to Month 36)
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36)
Délai: Baseline and final assessment (up to Month 36)
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36)
Délai: Baseline and final assessment (up to Month 36)
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
Délai: Baseline and final assessment (up to Month 36)
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Baseline and final assessment (up to Month 36)
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Change From Baseline in Height at Final Assessment (up to Month 36)
Délai: Baseline and final assessment (up to Month 36)
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Baseline and final assessment (up to Month 36)
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Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36)
Délai: Final assessment (up to Month 36)
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Final assessment (up to Month 36)
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Number of Participants Who Had One or More Adverse Drug Reactions
Délai: Up to Month 36
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Adverse drug reaction refers to adverse events related to the administered drug.
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Up to Month 36
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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 (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies métaboliques
- Blessures et Blessures
- Maladies musculo-squelettiques
- Maladies osseuses
- Maladies osseuses métaboliques
- Fractures, Os
- Ostéoporose
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Modulateurs de transport membranaire
- Agents de conservation de la densité osseuse
- Hormones et agents régulateurs du calcium
- Bloqueurs de canaux calciques
- Acide risédronique
Autres numéros d'identification d'étude
- 178-002
- JapicCTI-142479 (Identificateur de registre: JapicCTI)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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Essais cliniques sur Sodium risedronate
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Institut d'Anesthesiologie des Alpes MaritimesUniversité de Nice Sophia Antipolis; Medical University of GrenobleComplété
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University of DelawareComplété
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Radboud University Medical CenterInconnueDiabète de type 1 | Ignorance de l'hypoglycémiePays-Bas
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Austin HealthComplétéSyndrome de réponse inflammatoire systémique | Insuffisance rénale | OligurieAustralie
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Medical University of GrazComplétéCrise cardiaqueL'Autriche
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Osaka General Medical CenterComplétéProcédure coronarienne urgenteJapon
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Lars Wiuff AndersenUniversity of AarhusRecrutement
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Radboud University Medical CenterEuropean Foundation for the Study of Diabetes; Dutch Diabetes Research FoundationComplétéDiabète sucré de type 1 avec hypoglycémiePays-Bas