A Study of Adherence to Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP).
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Menopausal Osteoporosis
Intervention: ibandronate [Bonviva/Boniva] (Drug); ibandronate [Bonviva/Boniva] (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
Summary
This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using serum CTX and
communication of results at 3 months, on adherence to once monthly Bonviva (150mg po) in
women with post-menopausal osteoporosis supported by PRP. Patients 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, and the target sample size is 500+ individuals.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group
Secondary outcome: Patient satisfaction by OPSAT-Q and OPPSSerum CTX levels AEs and laboratory parameters
Eligibility
Minimum age: 55 Years.
Maximum age: 85 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- ambulatory, post-menopausal women with osteoporosis;
- 55-85 years of age;
- eligible for bisphosphonate treatment;
- naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake >= 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.
Locations and Contacts
BUDAPEST 1027, Hungary
BUDAPEST 1113, Hungary
SZEGED 6720, Hungary
BÉKÉSCSABA 5600, Hungary
MISKOLC 3529, Hungary
SZEKESFEHERVAR 8000, Hungary
SZOMBATHELY 9700, Hungary
PECS 7624, Hungary
DEBRECEN 4043, Hungary
BUDAPEST 1032, Hungary
RIGA 1038, Latvia
RIGA 1004, Latvia
RIGA 1012, Latvia
LIEPAJA 3400, Latvia
KRAKOW 30-510, Poland
POZNAN 60-355, Poland
WARSZAWA 00-719, Poland
WROCLAW 50-367, Poland
GLIWICE 44-100, Poland
WARSZAWA 02-637, Poland
LODZ 90-549, Poland
WARSZAWA 00-909, Poland
WARSZAWA 02-507, Poland
TIMISOARA 300736, Romania
CONSTANTA 900709, Romania
BUCHAREST 011172, Romania
CRAIOVA 300941, Romania
CLUJ-NAPOCA 400006, Romania
BUCHAREST 011364, Romania
BUCHAREST 011461, Romania
BUCHAREST 011863, Romania
MOSCOW 129110, Russian Federation
MOSCOW 117036, Russian Federation
MOSCOW 115552, Russian Federation
MOSCOW 127299, Russian Federation
MOSCOW 117997, Russian Federation
MOSCOW 125315, Russian Federation
ST PETERSBURG 199034, Russian Federation
ST PETERSBURG 190068, Russian Federation
YAROSLAVL 150003, Russian Federation
EKATERINBURG 620102, Russian Federation
MOSCOW 101990, Russian Federation
MOSCOW 127473, Russian Federation
MOSCOW 111123, Russian Federation
IRKUTSK 664047, Russian Federation
VORONEZH 394066, Russian Federation
BRATISLAVA 826 06, Slovakia
LUBOCHNA 034 91, Slovakia
PIESTANY 921 12, Slovakia
BANSKA BYSTRICA 975 17, Slovakia
PRESOV 080 01, Slovakia
LJUBLJANA 1525, Slovenia
Additional Information
Starting date: May 2006
Ending date: February 2008
Last updated: June 17, 2008
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