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

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ClinicalTrials.gov Identifier: NCT00545480
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : August 18, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Post Menopausal Osteoporosis Drug: ibandronate [Bonviva/Boniva] Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 596 participants
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.
Study Start Date : July 2006
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  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 Outcome Measures :
  1. Differences between groups in persistence [ Time Frame: 6 months ]
  2. QoL and patient satisfaction [ Time Frame: 6 and 12 months ]


Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545480


  Show 191 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
GlaxoSmithKline
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545480     History of Changes
Other Study ID Numbers: ML19358
First Posted: October 17, 2007    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Ibandronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs