BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis

Roche

Status and phase

Completed

Phase 4

Conditions

Postmenopausal Osteoporosis

Treatments

Drug: ibandronate [Bonviva/Boniva]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00545909

ML19913

Details and patient eligibility

About

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.

Enrollment

585 patients

Sex

Female

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

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.