A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)
31 août 2016 mis à jour par: Hoffmann-La Roche
A Randomized Open-Label Study to Investigate the Impact of Bone Marker Feedback at 3 Months on Adherence to Monthly Oral Bonviva in Women With Post-Menopausal Osteoporosis Supported by a Patient Relationship Program
This 2 arm study will assess the impact of bone marker feedback (BMF), using serum carboxy-terminal collagen crosslinks (CTX) and communication of results at 3 months, on adherence to once monthly ibandronate (150 milligrams [mg] per oral [po]) in women with post-menopausal osteoporosis supported by patient-relationship program (PRP).
Participants will be randomized either to receive BMF or no BMF; both groups will be supported by PRP.
The anticipated time on study treatment is 3-12 months.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
716
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Ekaterinburg, Fédération Russe, 620102
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Irkutsk, Fédération Russe, 664047
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Moscow, Fédération Russe, 111123
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Moscow, Fédération Russe, 129110
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Moscow, Fédération Russe, 117997
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Moscow, Fédération Russe, 127299
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Moscow, Fédération Russe, 117036
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Moscow, Fédération Russe, 125315
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Moscow, Fédération Russe, 101990
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Moscow, Fédération Russe, 115552
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Moscow, Fédération Russe, 127473
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St Petersburg, Fédération Russe, 199034
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St Petersburg, Fédération Russe, 190068
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Voronezh, Fédération Russe, 394066
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Yaroslavl, Fédération Russe, 150003
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Budapest, Hongrie, 1032
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Budapest, Hongrie, 1027
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Budapest, Hongrie, 1113
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Békéscsaba, Hongrie, 5600
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Debrecen, Hongrie, 4043
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Miskolc, Hongrie, 3529
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Pecs, Hongrie, 7624
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Szeged, Hongrie, 6720
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Szekesfehervar, Hongrie, 8000
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Szombathely, Hongrie, 9700
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Liepaja, Lettonie, 3400
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Riga, Lettonie, 1038
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Riga, Lettonie, 1004
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Riga, Lettonie, LV-1012
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Gliwice, Pologne, 44-100
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Krakow, Pologne, 30-510
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Lodz, Pologne, 90-549
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Poznan, Pologne, 60-355
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Warszawa, Pologne, 02-637
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Warszawa, Pologne, 00-909
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Warszawa, Pologne, 00-719
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Warszawa, Pologne, 02-507
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Wroclaw, Pologne, 50-367
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Bucharest, Roumanie, 011172
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Bucharest, Roumanie, 011364
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Bucharest, Roumanie, 011461
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Bucharest, Roumanie, 011863
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Cluj-napoca, Roumanie, 400006
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Constanta, Roumanie, 900709
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Craiova, Roumanie, 300941
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Timisoara, Roumanie, 300736
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Banska Bystrica, Slovaquie, 975 17
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Bratislava, Slovaquie, 826 06
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Lubochna, Slovaquie, 034 91
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Piestany, Slovaquie, 921 12
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Presov, Slovaquie, 080 01
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Ljubljana, Slovénie, 1525
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
55 ans à 85 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
- ambulatory, post-menopausal women with osteoporosis;
- eligible for bisphosphonate treatment;
- naïve to bisphosphonate therapy, or lapsed users (last bisphosphonate intake greater than or equal to [>=] 6 months ago).
Exclusion Criteria:
- inability to stand or sit upright for at least 60 minutes;
- inability to swallow a tablet whole;
- hypersensitivity to bisphosphonates;
- treatment with drugs, or presence of active disease, known to influence bone metabolism;
- history of upper gastrointestinal disease.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Bone Marker Feedback (BMF) Participants
Postmenopausal women will receive ibandronate 150 milligrams (mg) once monthly (QM) orally for 6 months.
Participants, in this arm, will receive BMF at Month 3. BMF will be given in terms of providing serum carboxy-terminal collagen crosslinks (CTX) level at Month 3. A "BMF-form" will be provided to the physicians to allow offering the bone marker result in an easy way.
Participants will be informed if their results are within or outside of the desired range.
In addition, participants will also supported by PRP, to be carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
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Participants will receive ibandronate 150 mg QM orally for 6 months.
Autres noms:
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Comparateur actif: No BMF Participants
Postmenopausal women will receive ibandronate 150 milligrams (mg) once monthly (QM) orally for 6 months.
Participants will be supported by PRP, to be carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
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Participants will receive ibandronate 150 mg QM orally for 6 months.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Percentage of Participants With Adherence to Treatment
Délai: Up to 6 months
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Participants were considered adherent to treatment if they took at least 83 percent (%) of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month.
Participant adherence was assessed by maintaining records of 'drug dispensed' and 'drug returned' on case report form (CRF) and participant's self-report on Visit 2 (Month 3) and final study visit (Month 6).
A drug dispensing log was maintained by the investigator.
Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.
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Up to 6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores
Délai: At Month 6
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The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment.
It comprises four domains: convenience (questions 1 - 6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11 - 16).
Satisfaction with treatment was assessed using the OPSAT-Q composite satisfaction score, which was the average of the scores from the four domains of the OPSAT-Q converted to a 0 - 100-point scale.
Higher scores indicated greater treatment satisfaction.
A score of 80 or more was considered as high score.
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At Month 6
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Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score
Délai: At Month 6
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OPPS: A standardized 6-item satisfaction questionnaire for osteoporosis medical care and treatment received during the study.
Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction.
The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction.
OMSQ: A standardized 18-item satisfaction questionnaire for osteoporosis medical care, treatment received and blood test and their results during the study.
Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction.
The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction.
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At Month 6
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Percent Change From Baseline in CTX Based on Adherence to Ibandronate
Délai: Baseline, Month 6
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Serum CTX, a biochemical marker of bone resorption, was assessed for all participants at baseline and at final visit (Month 6).
The sampling was done at the same time of the day each time to overcome the effect of circadian fluctuations.
Participants were considered adherent to treatment if they took at least 83% of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month.
Participant adherence was assessed by maintaining records of 'drug dispensed' and 'drug returned' on CRF and participant's self-report on Visit 2 (Month 3) and final study visit (Month 6).
A drug dispensing log was maintained by the investigator.
Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.
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Baseline, Month 6
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2006
Achèvement primaire (Réel)
1 janvier 2008
Achèvement de l'étude (Réel)
1 janvier 2008
Dates d'inscription aux études
Première soumission
16 octobre 2007
Première soumission répondant aux critères de contrôle qualité
16 octobre 2007
Première publication (Estimation)
17 octobre 2007
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
24 octobre 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 août 2016
Dernière vérification
1 août 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ML19982
- 2005-005529-74 (Numéro EudraCT)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .