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Completed

NCT Number: NCT00545909

BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly 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.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

55 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Bregenz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ibandronate [Bonviva/Boniva]

Drug

150mg po monthly for 6 months (+ feedback)

Primary outcomes

  1. Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group

    Time frame: 6 months

Secondary outcomes

  1. Patient satisfaction by OPSAT-Q and OPPS.

    Time frame: 6 months

  2. Tolerability; SAEs.

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 17, 2007
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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