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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00545090
Enrollment
561
Registered
2007-10-17
Start date
2006-08-31
Completion date
2008-06-30
Last updated
2016-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Menopausal Osteoporosis

Brief summary

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.

Interventions

150mg po monthly for 6 months

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
SAEs, AEs including fractures, adherence to treatment, clinical improvement, osteoporosis symptomsThroughout study

Countries

Hong Kong, Indonesia, Philippines, Taiwan, Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026