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

Roche

Status and phase: Completed; Phase 4

Conditions: Post Menopausal Osteoporosis

Treatments: Drug: ibandronate [Bonviva/Boniva]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545480

ML19358

Details and patient eligibility

About

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.

Enrollment: 596 patients

Sex: Female

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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596 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: ibandronate [Bonviva/Boniva]

Drug: ibandronate [Bonviva/Boniva]

2

Active Comparator group

Treatment:

Drug: ibandronate [Bonviva/Boniva]

Drug: ibandronate [Bonviva/Boniva]