SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Collaborator:
GlaxoSmithKline
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545480
First received: October 16, 2007
Last updated: October 15, 2009
Last verified: October 2009
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Purpose
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Differences between groups in persistence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- QoL and patient satisfaction [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Enrollment: | 596 |
Study Completion Date: | March 2009 |
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)
|
Eligibility
Ages Eligible for Study: | 55 Years and older |
Genders 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545480
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Sponsors and Collaborators
Hoffmann-La Roche
GlaxoSmithKline
Investigators
Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided by Hoffmann-La Roche
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
No publications provided by Hoffmann-La Roche
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Disclosures Group, Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00545480 History of Changes |
Other Study ID Numbers: | ML19358 |
Study First Received: | October 16, 2007 |
Last Updated: | October 15, 2009 |
Health Authority: | France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS) |
Additional relevant MeSH terms:
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Ibandronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 17, 2012