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-naïve 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 naïve 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 12Percent 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 24Percent 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
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