Clinical trial NCT00545909: BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis
Official title: A Randomised, Open Label Study to Investigate the Impact of Bone Marker Feedback at 2 Months on Adherence to Monthly Oral Bonviva (Ibandronate) in Women With Post-menopausal Osteoporosis.
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: 585
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 blood sampling and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group which receives bone marker feedback or 2)a group which does not receive feedback on the results. The study will also assess patient satisfaction with treatment with once monthly Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility 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 in an upright position for at least 60 minutes;
* inability to swallow a tablet whole;
* hypersensitivity to bisphosphonates;
* administration of any drug, or presence of active disease, known to influence bone metabolism;
* uncorrected hypocalcemia or other bone disturbances of bone and mineral metabolism;
* history of major upper gastrointestinal disease.

Primary outcomes:
measure: Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group
timeFrame: 6 months
Secondary outcomes:
measure: Patient satisfaction by OPSAT-Q and OPPS.
timeFrame: 6 months
measure: Tolerability; SAEs.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Bregenz
country: Austria
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Salzburg
country: Austria
city: Vöcklabruck
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Aalst
country: Belgium
city: Antwerpen
country: Belgium
city: Antwerpen
country: Belgium
city: AYE
country: Belgium
city: Braine L'alleud
country: Belgium
city: Brugge
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Charleroi
country: Belgium
city: Dinant
country: Belgium
city: Ekeren
country: Belgium
city: Genk
country: Belgium
city: Gent
country: Belgium
city: Godinne
country: Belgium
city: Hasselt
country: Belgium
city: Jambes
country: Belgium
city: Knokke
country: Belgium
city: Kortrijk
country: Belgium
city: La Louviere
country: Belgium
city: Liege
country: Belgium
city: Liege
country: Belgium
city: Mechelen
country: Belgium
city: Merksem
country: Belgium
city: Mons
country: Belgium
city: Oostende
country: Belgium
city: Roeselare
country: Belgium
city: Sijsele
country: Belgium
city: Tournai
country: Belgium
city: Turnhout
country: Belgium
city: Waremme
country: Belgium
city: Wilrijk
country: Belgium
city: Athens
country: Greece
city: Athens
country: Greece
city: Kifissia
country: Greece
city: Larissa
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Gorey
country: Ireland
city: Tipperary
country: Ireland
city: Luxembourg
country: Luxembourg
city: Luxembourg
country: Luxembourg
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: