Status:
COMPLETED
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Post-Menopausal Osteopenia
Eligibility:
FEMALE
45-60 years
Phase:
PHASE4
Brief Summary
This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either ...
Eligibility Criteria
Inclusion
- women 45-60 years of age;
- post-menopausal;
- ambulatory.
Exclusion
- vertebral fracture (except traumatic fracture such as in a motor vehicle accident);
- low-trauma osteoporotic fracture in any other bone;
- breast cancer diagnosed within last 20 years;
- other malignancy diagnosed within last 10 years, except successfully resected basal cell cancer;
- treatment with any bisphosphonate within last 2 years;
- treatment with other drugs affecting bone metabolism within last 6 months.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00129623
Start Date
December 1 2005
End Date
December 1 2007
Last Update
January 11 2016
Active Locations (12)
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1
Lakewood, Colorado, United States, 80227
2
Stuart, Florida, United States, 34996
3
Bethesda, Maryland, United States, 20817
4
Detroit, Michigan, United States, 48236