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

Postmenopausal Osteoporosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545909
• Other study ID #: ML19913
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2007
• Last updated: November 1, 2016
• Start date: March 2006
• Est. completion date: August 2008

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Agence federale des medicaments at des produits de sante
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 585
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 85 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months (+ feedback)
• ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months (- feedback)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Austria,  Belgium,  Greece,  Ireland,  Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group		6 months	No
Secondary	Patient satisfaction by OPSAT-Q and OPPS.		6 months	No
Secondary	Tolerability; SAEs.		Throughout study	Yes