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

Post Menopausal Osteoporosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545480
• Other study ID #: ML19358
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2007
• Last updated: August 17, 2015
• Start date: July 2006
• Est. completion date: March 2009

Study information

• Verified date: August 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 596
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Post Menopausal Osteoporosis

Intervention

Drug:
• ibandronate [Bonviva/Boniva]
150mg po monthly for 12 months (with feedback)
• ibandronate [Bonviva/Boniva]
150mg po monthly for 12 months (without feedback)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	GlaxoSmithKline

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group		12 months	No
Secondary	Differences between groups in persistence		6 months	No
Secondary	QoL and patient satisfaction		6 and 12 months	No