A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)
31. august 2016 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
716
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Ekaterinburg, Den russiske føderasjonen, 620102
-
Irkutsk, Den russiske føderasjonen, 664047
-
Moscow, Den russiske føderasjonen, 111123
-
Moscow, Den russiske føderasjonen, 129110
-
Moscow, Den russiske føderasjonen, 117997
-
Moscow, Den russiske føderasjonen, 127299
-
Moscow, Den russiske føderasjonen, 117036
-
Moscow, Den russiske føderasjonen, 125315
-
Moscow, Den russiske føderasjonen, 101990
-
Moscow, Den russiske føderasjonen, 115552
-
Moscow, Den russiske føderasjonen, 127473
-
St Petersburg, Den russiske føderasjonen, 199034
-
St Petersburg, Den russiske føderasjonen, 190068
-
Voronezh, Den russiske føderasjonen, 394066
-
Yaroslavl, Den russiske føderasjonen, 150003
-
-
-
-
-
Liepaja, Latvia, 3400
-
Riga, Latvia, 1038
-
Riga, Latvia, 1004
-
Riga, Latvia, LV-1012
-
-
-
-
-
Gliwice, Polen, 44-100
-
Krakow, Polen, 30-510
-
Lodz, Polen, 90-549
-
Poznan, Polen, 60-355
-
Warszawa, Polen, 02-637
-
Warszawa, Polen, 00-909
-
Warszawa, Polen, 00-719
-
Warszawa, Polen, 02-507
-
Wroclaw, Polen, 50-367
-
-
-
-
-
Bucharest, Romania, 011172
-
Bucharest, Romania, 011364
-
Bucharest, Romania, 011461
-
Bucharest, Romania, 011863
-
Cluj-napoca, Romania, 400006
-
Constanta, Romania, 900709
-
Craiova, Romania, 300941
-
Timisoara, Romania, 300736
-
-
-
-
-
Banska Bystrica, Slovakia, 975 17
-
Bratislava, Slovakia, 826 06
-
Lubochna, Slovakia, 034 91
-
Piestany, Slovakia, 921 12
-
Presov, Slovakia, 080 01
-
-
-
-
-
Ljubljana, Slovenia, 1525
-
-
-
-
-
Budapest, Ungarn, 1032
-
Budapest, Ungarn, 1027
-
Budapest, Ungarn, 1113
-
Békéscsaba, Ungarn, 5600
-
Debrecen, Ungarn, 4043
-
Miskolc, Ungarn, 3529
-
Pecs, Ungarn, 7624
-
Szeged, Ungarn, 6720
-
Szekesfehervar, Ungarn, 8000
-
Szombathely, Ungarn, 9700
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
55 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Participants will receive ibandronate 150 mg QM orally for 6 months.
Andre navn:
|
|
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.
|
Participants will receive ibandronate 150 mg QM orally for 6 months.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants With Adherence to Treatment
Tidsramme: Up to 6 months
|
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.
|
Up to 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores
Tidsramme: At Month 6
|
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.
|
At Month 6
|
|
Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score
Tidsramme: At Month 6
|
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.
|
At Month 6
|
|
Percent Change From Baseline in CTX Based on Adherence to Ibandronate
Tidsramme: Baseline, Month 6
|
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.
|
Baseline, Month 6
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2006
Primær fullføring (Faktiske)
1. januar 2008
Studiet fullført (Faktiske)
1. januar 2008
Datoer for studieregistrering
Først innsendt
16. oktober 2007
Først innsendt som oppfylte QC-kriteriene
16. oktober 2007
Først lagt ut (Anslag)
17. oktober 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
24. oktober 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. august 2016
Sist bekreftet
1. august 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ML19982
- 2005-005529-74 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .