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

November 1, 2016 updated by: Hoffmann-La Roche

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

585

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Bregenz, Austria, 6900
      • Graz, Austria, 8036
      • Innsbruck, Austria, 6020
      • Linz, Austria, 4020
      • Salzburg, Austria, 5020
      • Vöcklabruck, Austria, 4840
      • Wien, Austria, 1100
      • Wien, Austria, 1130
      • Wien, Austria, 1160
      • Wien, Austria, 1060
      • Wien, Austria, 1021
      • Wien, Austria, 1150
  • Belgium
      • AYE, Belgium, 6900
      • Aalst, Belgium, 9300
      • Antwerpen, Belgium, 2020
      • Antwerpen, Belgium, 2018
      • Braine L'alleud, Belgium, 1420
      • Brugge, Belgium, 8000
      • Bruxelles, Belgium, 1020
      • Bruxelles, Belgium, 1200
      • Bruxelles, Belgium, 1180
      • Bruxelles, Belgium, 1000
      • Bruxelles, Belgium, 1040
      • Charleroi, Belgium, 6000
      • Dinant, Belgium, 5500
      • Ekeren, Belgium, 2180
      • Genk, Belgium, 3600
      • Gent, Belgium, 9000
      • Godinne, Belgium, 5530
      • Hasselt, Belgium, 3500
      • Jambes, Belgium, 5100
      • Knokke, Belgium, 8300
      • Kortrijk, Belgium, 8500
      • La Louviere, Belgium, 7100
      • Liege, Belgium, 4000
      • Liege, Belgium, 4020
      • Mechelen, Belgium, 2800
      • Merksem, Belgium, 2170
      • Mons, Belgium, 7000
      • Oostende, Belgium, 8400
      • Roeselare, Belgium, 8800
      • Sijsele, Belgium, 8340
      • Tournai, Belgium, 7500
      • Turnhout, Belgium, 2300
      • Waremme, Belgium, 4300
      • Wilrijk, Belgium, 2610
  • Greece
      • Athens, Greece, 10682
      • Athens, Greece, 16673
      • Kifissia, Greece, 14561
      • Larissa, Greece, 41110
      • Thessaloniki, Greece, 54636
      • Thessaloniki, Greece, 55132
      • Thessaloniki, Greece, 56429
  • Ireland
      • Gorey, Ireland
      • Tipperary, Ireland
  • Luxembourg
      • Luxembourg, Luxembourg, 2763
      • Luxembourg, Luxembourg, 2311

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months (+ feedback)
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)
Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months (- feedback)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

October 16, 2007

First Submitted That Met QC Criteria

October 16, 2007

First Posted (Estimate)

October 17, 2007

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML19913

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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