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Completed

NCT Number: NCT00545480

SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.

This 2 arm study will assess the impact of bone marker feedback, using blood sampling and communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. The study will also assess safety, quality of life and patient satisfaction. All patients will receive Bonviva 150mg po monthly, and will be randomized into the bio-feedback or no bio-feedback study arms. 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

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

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Agen, France

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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 who would benefit from bisphosphonate treatment;
  • >55 years of age;
  • naive to bisphosphonate therapy, or lapsed bisphosphonate users >=6 months.

Exclusion criteria

  • inability to stand or sit in an upright position for at least 60 minutes;
  • hypersensitivity to bisphosphonates;
  • treatment with other drugs affecting bone metabolism;
  • history of major upper gastrointestinal disease.

Treatment and study plan

ibandronate [Bonviva/Boniva]

Drug

150mg po monthly for 12 months (with feedback)

Primary outcomes

  1. Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group

    Time frame: 12 months

Secondary outcomes

  1. Differences between groups in persistence

    Time frame: 6 months

  2. QoL and patient satisfaction

    Time frame: 6 and 12 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

A Randomized, Open-label Study to Investigate the Impact of Bone Marker Feedback on Persistence to Once Monthly Oral Bonviva (Ibandronate) Treatment for Post-menopausal Osteoporosis.

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 17, 2007
Registry last updated
Aug 18, 2015

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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