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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00545090
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : November 10, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

October 16, 2007
October 17, 2007
November 10, 2016
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 ]
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 Archive Site
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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 monthly oral Bonviva in ML19930, the BonAdAsia study. All patients completing 6 months in ML19930 will continue to receive Bonviva (150mg po, monthly) for an additional 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
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Phase 4
Intervention Model: Single Group Assignment
Masking: None (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]
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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.
Sexes Eligible for Study: Female
up to 85 Years   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Hong Kong,   Indonesia,   Philippines,   Taiwan,   Thailand
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Hoffmann-La Roche
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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