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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545090
First received: October 16, 2007
Last updated: August 4, 2014
Last verified: August 2014

October 16, 2007
August 4, 2014
August 2006
June 2008   (final data collection date for primary outcome measure)
SAEs, AEs including fractures, adherence to treatment, clinical improvement, osteoporosis symptoms [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
SAEs, AEs including fractures; adherence to treatment; clinical improvement of osteoporosis; symptoms; fractures related to osteoporosis.
Complete list of historical versions of study NCT00545090 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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ExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
An Open-label, Clinical Observation Extension Study to Assess Continuing Safety and Adherence in Patients With Postmenopausal Osteoporosis Receiving Monthly Oral Bonviva

This single arm study will continue drug safety surveillance, and assessment of adherence, in patients with postmenopausal osteoporosis who have received monthl y oral Bonviva in ML19930, the BonAdAsia study. All patients completing 6 months in ML19930 will continue to receive Bonviva (150mg po, monthly) for an addition al 6 months. The anticipated time on study treatment is 3-12 months, and the tar get sample size is 500+ individuals.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Post-Menopausal Osteoporosis
Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months
Experimental: 1
Intervention: Drug: ibandronate [Bonviva/Boniva]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
561
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients responding to oral monthly Bonviva during the BonAdAsia study;
  • willing to continue Bonviva treatment for a further 6 months.

Exclusion Criteria:

  • none specified.
Female
up to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong,   Indonesia,   Philippines,   Taiwan,   Thailand
 
NCT00545090
ML19937
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP