A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)
31 augustus 2016 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
716
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Budapest, Hongarije, 1032
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Budapest, Hongarije, 1027
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Budapest, Hongarije, 1113
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Békéscsaba, Hongarije, 5600
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Debrecen, Hongarije, 4043
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Miskolc, Hongarije, 3529
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Pecs, Hongarije, 7624
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Szeged, Hongarije, 6720
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Szekesfehervar, Hongarije, 8000
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Szombathely, Hongarije, 9700
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Liepaja, Letland, 3400
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Riga, Letland, 1038
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Riga, Letland, 1004
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Riga, Letland, LV-1012
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Gliwice, Polen, 44-100
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Krakow, Polen, 30-510
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Lodz, Polen, 90-549
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Poznan, Polen, 60-355
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Warszawa, Polen, 02-637
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Warszawa, Polen, 00-909
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Warszawa, Polen, 00-719
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Warszawa, Polen, 02-507
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Wroclaw, Polen, 50-367
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Bucharest, Roemenië, 011172
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Bucharest, Roemenië, 011364
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Bucharest, Roemenië, 011461
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Bucharest, Roemenië, 011863
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Cluj-napoca, Roemenië, 400006
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Constanta, Roemenië, 900709
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Craiova, Roemenië, 300941
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Timisoara, Roemenië, 300736
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Ekaterinburg, Russische Federatie, 620102
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Irkutsk, Russische Federatie, 664047
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Moscow, Russische Federatie, 111123
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Moscow, Russische Federatie, 129110
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Moscow, Russische Federatie, 117997
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Moscow, Russische Federatie, 127299
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Moscow, Russische Federatie, 117036
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Moscow, Russische Federatie, 125315
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Moscow, Russische Federatie, 101990
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Moscow, Russische Federatie, 115552
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Moscow, Russische Federatie, 127473
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St Petersburg, Russische Federatie, 199034
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St Petersburg, Russische Federatie, 190068
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Voronezh, Russische Federatie, 394066
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Yaroslavl, Russische Federatie, 150003
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Ljubljana, Slovenië, 1525
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Banska Bystrica, Slowakije, 975 17
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Bratislava, Slowakije, 826 06
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Lubochna, Slowakije, 034 91
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Piestany, Slowakije, 921 12
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Presov, Slowakije, 080 01
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
55 jaar tot 85 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
Andere namen:
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Actieve vergelijker: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Participants With Adherence to Treatment
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2006
Primaire voltooiing (Werkelijk)
1 januari 2008
Studie voltooiing (Werkelijk)
1 januari 2008
Studieregistratiedata
Eerst ingediend
16 oktober 2007
Eerst ingediend dat voldeed aan de QC-criteria
16 oktober 2007
Eerst geplaatst (Schatting)
17 oktober 2007
Updates van studierecords
Laatste update geplaatst (Schatting)
24 oktober 2016
Laatste update ingediend die voldeed aan QC-criteria
31 augustus 2016
Laatst geverifieerd
1 augustus 2016
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ML19982
- 2005-005529-74 (EudraCT-nummer)
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