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A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post Menopausal Osteoporosis

Intervention: ibandronate [Bonviva/Boniva] (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

This single arm, open label study will assess the efficacy and safety of and compliance to treatment with Bonviva/Boniva (ibandronate) in biphosphonate-nave patients with post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg intravenously every three months. Anticipated time on study treatment is 12 months with a follow-up of 12 months.

Clinical Details

Official title: Interventional, Single Arm, Open Label Study of the Efficacy, Safety and Compliance to the Treatment With Intravenous (IV) Ibandronate (Bonviva) in the Postmenopausal Osteoporosis Treatment of Bisphosphonates nave Patients in Daily Practice

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12

Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24

Percent Change From Baseline in Mean Hip Bone BMD at Month 12

Percent Change From Baseline in Mean Hip BMD at Month 24

Secondary outcome:

Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24

Percent Change From Baseline in Total Hip T-score at Month 12 and 24

Percentage of Participants Who Received All Planned Study Medication (Compliance)

Correlation Coefficient of Participant's Profile With Compliance

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Female patients, > 50 years of age

- Diagnosed osteoporosis

- Bone mineral density < minus 2. 5 SD or osteoporotic fracture

- At least 3 years after menopause

Exclusion Criteria:

- Impaired renal function

- Contra-indication to Calcium or Vitamin D therapy

- Previous or current treatment with biphosphonates

Locations and Contacts

Banja Luka 78000, Bosnia and Herzegovina

Sarajewo 71000, Bosnia and Herzegovina

Additional Information

Starting date: April 2011
Last updated: July 17, 2015

Page last updated: August 23, 2015

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