This phase III study was designed to test the non-inferiority (based on the percent change in lumbar spine BMD from baseline see more after 1 year) of the risedronate 35 mg DR weekly formulation taken before or after breakfast compared

to the 5 mg daily IR dose taken per label. Comparison to the 5 mg daily dose of risedronate IR instead of the 35 mg weekly dose was performed to meet regulatory guidelines for the approval of new formulations of a previously approved drug. The efficacy and safety results for the first year of the study are reported here. Methods and materials Study design This randomized, double-blind, active-controlled, parallel-group study was conducted at 43 study centers in North America, South America, and the European Union. The first subject was screened in November 2007,

and the last subject observation for the first year of the study took place in April 2009. The study was performed Adriamycin research buy in accordance with good clinical practice and the ethical principles that have their origin in the Declaration of Helsinki. The protocol was approved by the appropriate institutional review boards or ethics committees, and the subjects gave PI3K Inhibitor Library nmr written, informed consent to participate. Subjects Women were eligible to enroll in the study if they were at least 50 years of age, ambulatory, in generally good health, postmenopausal (at least 5 years since last menses), had at least three vertebral bodies in the lumbar spine (L1 to L4) evaluable by densitometry (i.e., without fracture or degenerative disease), and had a lumbar spine or total hip BMD corresponding to a T-score of −2.5 or lower or a T-score of −2.0 or lower with at least one prevalent vertebral fracture (T4 to L4). Exclusion criteria included contraindications to oral bisphosphonate therapy, lumbar spine BMD corresponding to a T-score of −5 or lower, use of medications that could interfere with the study evaluations, conditions that would interfere with the BMD measurements,

Tolmetin bilateral hip prostheses, body mass index greater than 32 kg/m2, allergy to bisphosphonates, history of cancer in the last 5 years (excluding basal or squamous skin cancers or successfully treated cervical cancer in situ), drug or alcohol abuse, abnormal clinical laboratory measurements, creatinine clearance less than 30 mL/min, hypo- or hypercalcemia, history of hyperparathyroidism or hyperthyroidism (unless corrected), osteomalacia, and any previous or ongoing condition that the investigator judged could prevent the subject from being able to complete the study. Eligible subjects who gave consent were stratified by anti-coagulant use (since fecal occult blood testing was performed during the study) and randomly assigned in a 1:1:1 ratio to the three treatment groups.