A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis

A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis.

The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

The comparator arms of this risedronate study are 35 mg delayed release given weekly and 5 mg immediate release given daily.

Inclusion Criteria:

• Female: 50 years of age or older
• >5 years since last menses natural or surgical
• have lumbar spine or total hip BMD more that 2.5 SD below the young adult mean, or have lumbar spine or total hip 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 >32 kg/m
• 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