A Study of Monthly Risedronate for Osteoporosis

A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO)

The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.

Inclusion Criteria:

• Female: 50 years of age or older
• >5 years since last menses natural or surgical
• have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture

Exclusion Criteria:

• history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
• BMI (body mass index) >32 kg/m^2
• use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
• hypocalcemia or hypercalcemia of any cause
• markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator