a study of arzoxifene to treat korean women with osteoporosis

Conditions: Osteoporosis

Summary: the study is for korean women who are postmenopausal and also suffer from osteoporosis. the study will test if women who are given 20 mg of arzoxifene once a day for six months have a less severe level of osteoporosis than those women who do not take arzoxifene. all patients will receive 500 mg of elemental calcium and 400 to 600 iu vitamin d daily starting 4 weeks prior to study drug administration continuing through the 6 months of therapy.


Eligibility criteria:
inclusion criteria: * present with osteoporosis based on total hip, femoral neck or lumbar spine bmd t-score of less than or equal to -2.5 but must never have had any osteoporotic fragility fracture. * are ambulatory and are 60 to 85 years of age, inclusive. aside from diagnosed osteoporosis (inclusion criterion \[1\]), all women must be free of severe or chronically disabling conditions, have a life expectancy of at least 5 years in the opinion of the investigator, be expected to remain ambulatory throughout the entire study, and be expected to return for follow-up visits. * had their last natural menstrual period at least 2 years before beginning the study. * are able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study. * have at least two lumbar vertebrae (l1 to l4) that are evaluable via dual energy x-ray absorptiometry (dxa) and lateral thoracic and lumbar spine x-ray films that can be adequately evaluated for existing vertebral fractures at screening. * have centrally read total hip, femoral neck or lumbar spine t-score less than or equal to -2.5 exclusion criteria: * have known current metabolic bone disorders other than low bone mass, such as hyperparathyroidism, renal osteodystrophy, or osteomalacia. * have known, suspected, or history of carcinoma of the breast or estrogen-dependent neoplasia (e.g., endometrial or uterine carcinoma), except for hysterectomized patients with a history of carcinoma in situ of the uterus. for other cancers, be disease free and in remission from all other cancers for 5 or more years, except for excised superficial lesions, such as basal cell carcinoma or squamous cell carcinoma of the skin. * have demonstrated or suspected allergy to raloxifene or arzoxifene * have unexplained or abnormal vaginal bleeding within 6 months prior to visit 1 or between visit 1 and visit 2. * are experiencing clinically severe postmenopausal symptoms that may require estrogen-replacement therapy. * have a history of or suggestion on ultrasound or pelvic examination of a pre-existing gynecologic abnormality that would require further gynecologic treatment (e.g., ovarian cysts, large fibroids, undiagnosed adnexal masses) or of baseline endometrial thickness of \>5 mm. * have papanicolaou's tests showing malignant or premalignant findings. * have active or any past history of thromboembolic events * have active or any past history of atrial fibrillation. * have a history of cerebrovascular accident or documented transient ischemic attack at any time in the past. * have acute or chronic liver disease defined as alanine aminotransaminase (alt) \>100 u/l, gamma-glutamyl transferase (ggt) \>400 u/l, or late stage cirrhosis without transaminase elevations. * have impaired kidney function (serum creatinine \>177 micromol/l or \>2.0 mg/dl). * have vitamin d deficiency prior to enrollment (visit 2; 25-hydroxyvitamin d less than10 ng/ml or less than 24.9 nmol/l). * have any known, severe, or untreated malabsorption syndromes. * have endocrine disorders requiring pharmacologic therapy except for type ii diabetes and hypothyroidism. patients on a stable dose of thyroid replacement therapy during the 6 months preceding randomization (visit 2) who are clinically euthyroid in the opinion of the investigator may enroll in the trial. * consume an excess of alcohol or abuse drugs * represent an unacceptable medical or psychiatric risk for treatment with an investigational drug * have active or any history of seizure disorder.