The efficacy and safety results after 24 months of treatment are reported here. Materials and methods 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 took place in April 2010. The study was performed 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 written, HDAC inhibitor informed consent
to participate. The Identifier number for this study at Clinicaltrials.gov
was NCT00541658. Subjects This has been described in detail previously [1]. Postmenopausal women were eligible to participate in the study if they were at least 50 years of age, ambulatory, had osteoporosis defined as a BMD T-score in the lumbar spine or total hip of −2.5 or lower or a T-score of −2.0 or lower with at least one prevalent vertebral fracture (T4 to L4), and were in generally good health without contraindications to risedronate therapy or other reasons to not be in the clinical study. Those A-1155463 in vivo subjects with baseline serum 25-hydroxyvitamin D levels <12 ng/ml were not eligible to participate in the study. Treatments Subjects were randomly assigned to one of three treatment groups: risedronate 5 mg IR daily or risedronate 35 mg DR once weekly before or immediately following breakfast. The minimization method of Pocock and Simon was used for randomization [8]. Eligible subjects who gave consent were stratified across study centers by anticoagulant use (since fecal occult blood testing was performed during the first 12 months of the study) and then randomly assigned within each study center in a 1:1:1 ratio to the three treatment groups. All subjects took nine study tablets each week: an IR tablet
or placebo before Vasopressin Receptor breakfast daily; a 35-mg DR tablet or placebo before breakfast once weekly (DR BB); and another 35-mg DR tablet or placebo following breakfast once weekly (DR FB). All placebo tablets were Sapanisertib purchase identical in appearance to their corresponding active tablets (i.e., 5 mg IR or 35 mg DR) and supplied in identical blister cards. The 5-mg IR tablets and the 35-mg DR tablets assigned for before-breakfast intake were taken on an empty stomach in the morning at least 30 min before the first food or drink of the day; the 35-mg DR tablets assigned for following-breakfast intake were taken immediately after breakfast. All tablets were taken with at least 4 ounces of plain water, and subjects were instructed to remain in an upright position for at least 30 min after dosing. Compliance was assessed by tablet counts.