Osteoporosis Postmenopausal Clinical Trial
Official title:
A Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Noninferiority Study Comparing 75mg Risedronate Dosed on 2 Consecutive Days Monthly With 5mg Daily Risedronate in the Treatment of Postmenopausal Osteoporosis as Assessed Over 24 Months.
To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per
month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar
spine in postmenopausal women with osteoporosis.
To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month
in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral
neck and femoral trochanter and decreasing bone resorption.
To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month
as compared to 5 mg risedronate taken daily.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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