Clinical trial NCT00545363: A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 716
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Adherence to Treatment
timeFrame: Up to 6 months
Secondary outcomes:
measure: Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores
timeFrame: At Month 6
measure: Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score
timeFrame: At Month 6
measure: Percent Change From Baseline in CTX Based on Adherence to Ibandronate
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Békéscsaba
country: Hungary
city: Debrecen
country: Hungary
city: Miskolc
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szombathely
country: Hungary
city: Liepaja
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Gliwice
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Cluj-napoca
country: Romania
city: Constanta
country: Romania
city: Craiova
country: Romania
city: Timisoara
country: Romania
city: Ekaterinburg
country: Russian Federation
city: Irkutsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Voronezh
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Lubochna
country: Slovakia
city: Piestany
country: Slovakia
city: Presov
country: Slovakia
city: Ljubljana
country: Slovenia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: