Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-31 @ 2:26 AM
Study NCT ID:
NCT01128257
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2010-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
Controllability and Real Life Efficacy of Bonviva 3 mg iv Quarterly vs. Oral Alendronate Generics
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This observational study will assess the compliance and persistence of patients, real life efficacy and safety of intravenously quarterly administered 3 mg ibandronate \[Bonviva/Boniva\] in comparison to oral alendronate generics in female patients with post-menopausal osteoporosis. The anticipated time of assessment is 12 months. The target sample size is 5000-7000 patients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: