This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
150mg po monthly for 2 years
po monthly for 2 years
Unnamed facility
Lyon, France
Unnamed facility
Paris, France
Unnamed facility
Saint-Priest-en-Jarez, France
Unnamed facility
Toulouse, France
Trabecular BV/TV at distal radius of non-dominant arm
Time frame: 12 arms
Trabecular BV/TV at distal radius of non-dominant arm
Time frame: 6 months and 2 years
Bone density, trabecular BV/TV at distal tibia
Time frame: 6 months, 1 and 2 years
Serum CTX
Time frame: Intervals throughout study
Lumbar hip and wrist BMD
Time frame: 1 and 2 years
AEs and laboratory parameters
Time frame: Throughout study
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