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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: October 16, 2007
Last updated: August 17, 2015
Last verified: August 2015
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.

Condition Intervention Phase
Post Menopausal 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 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.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Differences between groups in persistence [ Time Frame: 6 months ]
  • QoL and patient satisfaction [ Time Frame: 6 and 12 months ]

Enrollment: 596
Study Start Date: July 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 12 months (with feedback)
Active Comparator: 2 Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 12 months (without feedback)


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

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00545480

  Show 191 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00545480     History of Changes
Other Study ID Numbers: ML19358
Study First Received: October 16, 2007
Last Updated: August 17, 2015

Additional relevant MeSH terms:
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Ibandronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on September 21, 2017