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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
ClinicalTrials.gov processed this data on August 23, 2015
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: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche


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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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 OPPS

Serum CTX levels

AEs and laboratory parameters


Minimum age: 55 Years. Maximum age: 85 Years. Gender(s): Female.


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


- history of upper gastrointestinal disease.

Locations and Contacts

Budapest 1027, Hungary

Budapest 1032, Hungary

Budapest 1113, Hungary

Békéscsaba 5600, Hungary

Debrecen 4043, Hungary

Miskolc 3529, Hungary

Pecs 7624, Hungary

Szeged 6720, Hungary

Szekesfehervar 8000, Hungary

Szombathely 9700, Hungary

Liepaja 3400, Latvia

Riga 1004, Latvia

Riga LV-1012, Latvia

Riga 1038, Latvia

Gliwice 44-100, Poland

Krakow 30-510, Poland

Lodz 90-549, Poland

Poznan 60-355, Poland

Warszawa 00-719, Poland

Warszawa 00-909, Poland

Warszawa 02-507, Poland

Warszawa 02-637, Poland

Wroclaw 50-367, Poland

Bucharest 011364, Romania

Bucharest 011172, Romania

Bucharest 011461, Romania

Bucharest 011863, Romania

Cluj-napoca 400006, Romania

Constanta 900709, Romania

Craiova 300941, Romania

Timisoara 300736, Romania

Ekaterinburg 620102, Russian Federation

Irkutsk 664047, Russian Federation

Moscow 101990, Russian Federation

Moscow 111123, Russian Federation

Moscow 129110, Russian Federation

Moscow 117036, Russian Federation

Moscow 117997, Russian Federation

Moscow 125315, Russian Federation

Moscow 127299, Russian Federation

Moscow 127473, Russian Federation

Moscow 115552, Russian Federation

St Petersburg 190068, Russian Federation

St Petersburg 199034, Russian Federation

Voronezh 394066, Russian Federation

Yaroslavl 150003, Russian Federation

Banska Bystrica 975 17, Slovakia

Bratislava 826 06, Slovakia

Lubochna 034 91, Slovakia

Piestany 921 12, Slovakia

Presov 080 01, Slovakia

Ljubljana 1525, Slovenia

Additional Information

Starting date: May 2006
Last updated: August 17, 2015

Page last updated: August 23, 2015

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