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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00545909

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
Post-Menopausal Osteoporosis	Drug: ibandronate [Bonviva/Boniva]	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient satisfaction by OPSAT-Q and OPPS. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Tolerability; SAEs. [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment:	585
Study Completion Date:	August 2008

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

Eligibility

Ages Eligible for Study:	55 Years to 85 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545909

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Locations

Austria

WIEN, Austria, 1100

WIEN, Austria, 1160

BREGENZ, Austria, 6900

SALZBURG, Austria, 5020

WIEN, Austria, 1060

GRAZ, Austria, 8036

INNSBRUCK, Austria, 6020

LINZ, Austria, 4020

WIEN, Austria, 1021

WIEN, Austria, 1150

VÖCKLABRUCK, Austria, 4840

WIEN, Austria, 1130
Belgium

GENT, Belgium, 9000

LIEGE, Belgium, 4000

SIJSELE, Belgium, 8340

BRUXELLES, Belgium, 1000

WAREMME, Belgium, 4300

GODINNE, Belgium, 5530

EKEREN, Belgium, 2180

ANTWERPEN, Belgium, 2020

WILRIJK, Belgium, 2610

OOSTENDE, Belgium, 8400

KORTRIJK, Belgium, 8500

BRUGGE, Belgium, 8000

ROESELARE, Belgium, 8800

KNOKKE, Belgium, 8300

GENT, Belgium, 9000

DINANT, Belgium, 5500

BRUXELLES, Belgium, 1020

BRUXELLES, Belgium, 1180

MERKSEM, Belgium, 2170

LIEGE, Belgium, 4020

CHARLEROI, Belgium, 6000

LA LOUVIERE, Belgium, 7100

BRUXELLES, Belgium, 1200

GENK, Belgium, 3600

MONS, Belgium, 7000

MECHELEN, Belgium, 2800

AALST, Belgium, 9300

TOURNAI, Belgium, 7500

AYE, Belgium, 6900

JAMBES, Belgium, 5100

ANTWERPEN, Belgium, 2018

TURNHOUT, Belgium, 2300

HASSELT, Belgium, 3500

BRAINE L'ALLEUD, Belgium, 1420

BRUXELLES, Belgium, 1040
Greece

KIFISSIA, Greece, 14561

ATHENS, Greece, 16673

THESSALONIKI, Greece, 55132

LARISSA, Greece, 41110

ATHENS, Greece, 10682

THESSALONIKI, Greece, 54636

THESSALONIKI, Greece, 56429
Ireland

TIPPERARY, Ireland

GOREY, Ireland
Luxembourg

LUXEMBOURG, Luxembourg, 2763

LUXEMBOURG, Luxembourg, 2311

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML19913
Study First Received:	October 16, 2007
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00545909 History of Changes
Health Authority:	Belgium: Agence federale des medicaments at des produits de sante

Additional relevant MeSH terms:

Ibandronic acid
Musculoskeletal Diseases
Physiological Effects of Drugs
Osteoporosis, Postmenopausal
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009