- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02791555
Effect of Pradaxa vs Warfarin on Bone Mass and Bone Turnover Markers
Comparison of the Effects of the Direct Thrombin Inhibitor, Pradaxa, to That of Warfarin on Bone Mass and Bone Turnover Markers
Aperçu de l'étude
Statut
Les conditions
Description détaillée
1.0 Hypothesis: The direct thrombin inhibitor Pradaxa positively affects bone turnover markers and increases bone mineral density in women and men at risk for osteoporosis.
2.0 Goal: The goal of this study is to establish if the direct thrombin inhibitor Pradaxa positively affects bone turnover markers and increases bone mineral density in women and men at risk for osteoporosis.
3.0 Specific Aims.
3.1 To determine the effect of Pradaxa on bone mineral density in patients after 6 and 12 months of daily use.
3.2 To determine the effect of the direct thrombin inhibitor Pradaxa on bone turnover markers for osteoclastic resorption (measured as serum levels of C-terminal peptide, and N-telopeptide) and osteoblastic formation (measured as serum levels of bone-specific alkaline phosphatase, osteocalcin and P1NP) in subjects after 6 and 12 months of daily use.
3.3 To evaluate any correlation among the hemoclot, thrombin inhibitor test, changes in markers of bone turnover and changes in bone mineral density in patients on Pradaxa.
3.4 To determine the effect of Pradaxa on change in serum levels of receptor activator of NF B-ligand (RANKL), osteoprotegerin (OPG), RANKL/OPG ratio, inflammatory markers (IL-1b, IL-6, TNF-alpha and FGF-23) and inhibitors of Wnt/beta-catenin signaling pathway including sclerostin and DKK1 at baseline, 6 and 12 months, to understand the mechanisms for the effect of Pradaxa on bone.
4.0 Study design and procedures.
4.1 Study Design:
This will be a prospective, Phase IV age-matched cohort study in men and women who are being started on long-term treatment with Pradaxa for nonvalvular atrial fibrillation. This is a proof of concept study evaluating the effect of Pradaxa, a direct thrombin inhibitor on bone density and bone turnover markers in comparison to warfarin.
4.2 Subject Population:
The investigators will be recruiting patients with nonvalvular atrial fibrillation who are being prescribed Pradaxa by their cardiologists or primary care providers for long-term anticoagulant treatment for participation in the study. The patients taking Pradaxa will be the study group, and will be compared to an age-matched cohort of men and women with nonvalvular atrial fibrillation who are being started on long-term warfarin by their cardiologists or primary care providers (control group). The investigators will be evaluating 20 men and 20 women in the Pradaxa cohort and another age-matched 20 men and 20 women in the warfarin cohort (Pradaxa cohort: N = 40, 20 men, 20 women; Warfarin cohort: N = 40, 20 men, 20 women). The two groups will be determined based on treatment assigned to them by their cardiologists or primary care providers. As age can influence the risk for osteoporosis, the warfarin group will be age-matched to the Pradaxa group for optimal comparison. This will be achieved by offering participation to patients taking warfarin who are similar in age to the patients being recruited for the Pradaxa group. As women are more likely to develop osteoporosis and the effects of Pradaxa may be gender-based as a result of differences in the levels of sex hormones, the investigators are evaluating a cohort of men and women in this pilot study for comparison.
The investigators expect to see an older cohort of subjects with atrial fibrillation, who are also likely to have an increased risk of osteoporosis.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Connecticut
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Farmington, Connecticut, États-Unis, 06030
- University of Connecticut Health Center
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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:
- Age 50 and above, male and female starting on Pradaxa or Warfarin for nonvalvular atrial fibrillation
- Able to ambulate independently and travel to UConn Health in Farmington CT-
Exclusion Criteria:
- Prior known history of osteoporosis
- Chronic kidney disease with creatinine clearance less than 30
- Serum 25 hydroxyvitamin D level less than 10
- Ongoing treatment with medications that interfere with bone metabolism such as steroids, bisphosonates, denosumab, estrogen, SERMS
- Hypercalcemia, a history of Paget's disease, a history of multiple myeloma, or a history of monoclonal gammopathy of uncertain significance -
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Pradaxa
20 men and 20 women on Pradaxa for non valvular atrial fibrillation
|
Warfarin
20 men and 20 women on warfarin for non valvular atrial fibrillation, age matched to Pradaxa cohort
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in bone mineral density in patients
Délai: 6 and 12 months
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Measurement of bone density using DXA
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6 and 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in bone turnover markers
Délai: 6 and 12 months
|
Serum C-terminal and N- terminal telopeptide, Bone specific alkaline phosphatase, osteocalcin and P1NP
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6 and 12 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Joseph Lorenzo, MD, UConn Health
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 16-115-1
Plan pour les données individuelles des participants (IPD)
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