A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)
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
2 other identifiers
interventional
716
6 countries
51
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2006
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 16, 2007
CompletedFirst Posted
Study publicly available on registry
October 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedResults Posted
Study results publicly available
October 24, 2016
CompletedOctober 24, 2016
August 1, 2016
1.8 years
October 16, 2007
July 2, 2016
August 31, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adherence to Treatment
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
Secondary Outcomes (3)
Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores
At Month 6
Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score
At Month 6
Percent Change From Baseline in CTX Based on Adherence to Ibandronate
Baseline, Month 6
Study Arms (2)
Bone Marker Feedback (BMF) Participants
EXPERIMENTALPostmenopausal 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.
No BMF Participants
ACTIVE COMPARATORPostmenopausal 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.
Interventions
Participants will receive ibandronate 150 mg QM orally for 6 months.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Unknown Facility
Békéscsaba, 5600, Hungary
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Budapest, 1027, Hungary
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Budapest, 1032, Hungary
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Budapest, 1113, Hungary
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Debrecen, 4043, Hungary
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Miskolc, 3529, Hungary
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Pécs, 7624, Hungary
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Szeged, 6720, Hungary
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Székesfehérvár, 8000, Hungary
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Szombathely, 9700, Hungary
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Liepāja, 3400, Latvia
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Riga, 1004, Latvia
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Riga, 1038, Latvia
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Riga, LV-1012, Latvia
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Gliwice, 44-100, Poland
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Krakow, 30-510, Poland
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Lodz, 90-549, Poland
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Poznan, 60-355, Poland
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Warsaw, 00-719, Poland
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Warsaw, 00-909, Poland
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Warsaw, 02-507, Poland
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Warsaw, 02-637, Poland
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Wroclaw, 50-367, Poland
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Bucharest, 011172, Romania
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Bucharest, 011364, Romania
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Bucharest, 011461, Romania
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Bucharest, 011863, Romania
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Cluj-Napoca, 400006, Romania
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Constanța, 900709, Romania
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Craiova, 300941, Romania
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Timișoara, 300736, Romania
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Irkutsk, 664047, Russia
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Moscow, 101990, Russia
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Moscow, 111123, Russia
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Moscow, 115552, Russia
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Moscow, 117036, Russia
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Moscow, 117997, Russia
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Moscow, 125315, Russia
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Moscow, 127299, Russia
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Moscow, 127473, Russia
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Moscow, 129110, Russia
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Saint Petersburg, 190068, Russia
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Saint Petersburg, 199034, Russia
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Voronezh, 394066, Russia
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Yaroslavl, 150003, Russia
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Yekaterinburg, 620102, Russia
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Banská Bystrica, 975 17, Slovakia
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Bratislava, 826 06, Slovakia
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Ľubochňa, 034 91, Slovakia
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Piešťany, 921 12, Slovakia
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Prešov, 080 01, Slovakia
Unknown Facility
Ljubljana, 1525, Slovenia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2007
First Posted
October 17, 2007
Study Start
April 1, 2006
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
October 24, 2016
Results First Posted
October 24, 2016
Record last verified: 2016-08