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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00545909
Other study ID # ML19913
Secondary ID
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


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
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