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

NCT00545480 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 596

Last updated 2015-08-18

No results posted yet for this study

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.

Conditions

  • Post Menopausal Osteoporosis

Interventions

DRUG

ibandronate [Bonviva/Boniva]

150mg po monthly for 12 months (with feedback)

DRUG

ibandronate [Bonviva/Boniva]

150mg po monthly for 12 months (without feedback)

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00545480 on ClinicalTrials.gov