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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00545909

First Posted: October 17, 2007

Last Update Posted: November 2, 2016

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Information provided by (Responsible Party):

Hoffmann-La Roche

Purpose

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.

Condition	Intervention	Phase
Postmenopausal Osteoporosis	Drug: ibandronate [Bonviva/Boniva]	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Menopause Osteoporosis

Drug Information available for: Ibandronic acid Ibandronate sodium

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group [ Time Frame: 6 months ]

Secondary Outcome Measures:

Patient satisfaction by OPSAT-Q and OPPS. [ Time Frame: 6 months ]
Tolerability; SAEs. [ Time Frame: Throughout study ]


Enrollment:	585
Study Start Date:	March 2006
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: ibandronate [Bonviva/Boniva] 150mg po monthly for 6 months (+ feedback)
Active Comparator: 2	Drug: ibandronate [Bonviva/Boniva] 150mg po monthly for 6 months (- feedback)

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	55 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545909

Show 57 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche

More Information


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00545909 History of Changes
Other Study ID Numbers:	ML19913
First Submitted:	October 16, 2007
First Posted:	October 17, 2007
Last Update Posted:	November 2, 2016
Last Verified:	November 2016

Additional relevant MeSH terms:


Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases	Metabolic Diseases Ibandronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs

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