To evaluate the effect of subject knowledge of their disease status on persistence in subjects receiving Actonel 5 mg daily over a 12-month period for the prevention and treatment of GIO.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
248
Actonel 5 mg orally once daily (OD), calcium 500 mg + vitamin D 200 units twice daily (BID)
Sanofi-Aventis
Bridgewater, New Jersey, United States
Determine whether subject knowledge of baseline vertebral fracture prevalence and awareness of results of bone turnover marker (BTM)determinations would result in an increase in persistence with Actonel 5 mg daily therapy
Time frame: 12 months
Evaluate relationship between prevalence of vertebral fractures and duration of prior steroid therapy, amount of prior steroid therapy, and diagnosis of disease for which steroids were used
Time frame: 12 months
To evaluate the correlation between baseline vertebral fracture prevalence and subject persistence with Actonel 5 mg daily
Time frame: 12 months
Evaluate influence of Actonel 5 mg on BTM determinations and bone mineral density(BMD) at study finish relative to baseline
Time frame: 12 months
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