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

Tracking Information

First Received Date ^ICMJE

October 16, 2007

Last Updated Date

October 15, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Comparison of proportion of patients with persistence to >=10 out of 12 possible administrations of Bonviva (within 21 days of planned treatment date) and still on treatment at last visit.

Change History

Complete list of historical versions of study NCT00545480 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Predictive factors of better adherence; differences in persistence after 6 months; comparison of QOL and patient satisfaction at 6 months and 12 months. Safety: Adverse events.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Post-Menopausal Osteoporosis

Intervention ^ICMJE

Drug: ibandronate [Bonviva/Boniva]

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

596

Completion Date

March 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

55 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00545480

Responsible Party

Disclosures Group, Hoffmann-La Roche

Study ID Numbers ^ICMJE

ML19358

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP