A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)
31 augusti 2016 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
716
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Liepaja, Lettland, 3400
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Riga, Lettland, 1038
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Riga, Lettland, 1004
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Riga, Lettland, 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, Rumänien, 011172
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Bucharest, Rumänien, 011364
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Bucharest, Rumänien, 011461
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Bucharest, Rumänien, 011863
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Cluj-napoca, Rumänien, 400006
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Constanta, Rumänien, 900709
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Craiova, Rumänien, 300941
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Timisoara, Rumänien, 300736
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Ekaterinburg, Ryska Federationen, 620102
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Irkutsk, Ryska Federationen, 664047
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Moscow, Ryska Federationen, 111123
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Moscow, Ryska Federationen, 129110
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Moscow, Ryska Federationen, 117997
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Moscow, Ryska Federationen, 127299
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Moscow, Ryska Federationen, 117036
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Moscow, Ryska Federationen, 125315
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Moscow, Ryska Federationen, 101990
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Moscow, Ryska Federationen, 115552
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Moscow, Ryska Federationen, 127473
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St Petersburg, Ryska Federationen, 199034
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St Petersburg, Ryska Federationen, 190068
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Voronezh, Ryska Federationen, 394066
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Yaroslavl, Ryska Federationen, 150003
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Banska Bystrica, Slovakien, 975 17
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Bratislava, Slovakien, 826 06
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Lubochna, Slovakien, 034 91
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Piestany, Slovakien, 921 12
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Presov, Slovakien, 080 01
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Ljubljana, Slovenien, 1525
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Budapest, Ungern, 1032
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Budapest, Ungern, 1027
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Budapest, Ungern, 1113
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Békéscsaba, Ungern, 5600
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Debrecen, Ungern, 4043
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Miskolc, Ungern, 3529
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Pecs, Ungern, 7624
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Szeged, Ungern, 6720
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Szekesfehervar, Ungern, 8000
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Szombathely, Ungern, 9700
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
55 år till 85 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
Andra namn:
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Aktiv komparator: 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Percentage of Participants With Adherence to Treatment
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2006
Primärt slutförande (Faktisk)
1 januari 2008
Avslutad studie (Faktisk)
1 januari 2008
Studieregistreringsdatum
Först inskickad
16 oktober 2007
Först inskickad som uppfyllde QC-kriterierna
16 oktober 2007
Första postat (Uppskatta)
17 oktober 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
24 oktober 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 augusti 2016
Senast verifierad
1 augusti 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ML19982
- 2005-005529-74 (EudraCT-nummer)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .