Comparison of Tibolone and Raloxifene on Bone Mineral Density in Osteopenic Postmenopausal Women (P06090)

Inclusion Criteria: * Only subjects who give voluntary written informed consent, and who are willing and able to make reasonable efforts to observe all clinical trial requirements are to be enrolled. * Subjects will be osteopenic but otherwise healthy postmenopausal women, from 60 to 79 years of age (inclusive) at entry. * Screening BMD of the lumbar vertebrae (L1-L4) must be between -2.5 SD and * 1.0 SD of the T-score. * Subjects should have a Body Mass Index (BMI) \>19 and \< 30 kg/m2. Exclusion Criteria: * Spinal X -ray with symptomatic vertebral fracture (more than 20% reduction in expected vertebral height). * History of bilateral hip replacements. * Subjects who are not ambulatory. * History or presence of any malignancy, except non-melanoma skin cancers. * TVUS double wall thickness \> 4 mm, or any other undiagnosed abnormalities visualized by TVUS. * Abnormal cervical Pap smear result * Undiagnosed abnormal (in the investigator's opinion) vaginal bleeding in the past year prior to screening. * Mammography or physical examination finding that is suspicious of malignancy. * Uncontrolled hypertension * Bone disease other than osteoporosis such as Paget's disease, osteomalacia or bone metastases. * Drinking more than 4 glasses of alcohol containing drinks per day. * Smoking more than 20 cigarettes a day. * Current or recent prolonged use of hepatic microsomal enzyme-inducing anticonvulsant medication or other drugs known to interfere with or otherwise alter the pharmacokinetics of steroids. * Treatment with anabolic steroids, calcitonin or raloxifene within the last 6 months. * Treatment with alendronate and risedronate more than 6 months. If treatment duration was less than 6 months a wash-out period of 12 months is necessary. * Treatment with etidronate for 1 year a wash-out period of 6 months is necessary. If treatment period of more than 1 year a wash -out period of 12 months is necessary. * Treatment with oral estrogen and/or progestin therapy (including contraceptives) or transdermal therapy and local estrogen applications within 6 months prior to screening/baseline BMD measurements (i.e. the wash -out period of 6 months must have been completed before the screening / baseline BMD assessments are made). A 20-week wash-out for injections of MPA-containing contraceptives (e.g. Depo-Provera®) is required. * Ever use of estrogen and/or progestin containing implants. * The use of cholesterol-lowering medicine cholestyramine or colestipol. * Subjects with a change in thyroid medication within the last 6 weeks prior to screening. * Subjects who have had fluoride treatment for 2 weeks or more (\> 2 mg/day fluorideion) at any time (NaF tablets for caries prevention is allowed). * Subjects who have undergone systemic glucocorticoid treatment (\> 5 mg prednisone or equivalent/day) for more than one month within the past 6 months (prior to BMD screening assessments). * Subjects who are receiving or require medication for the treatment of osteoporosis except Calcium / Vit D. * The use of coumarin products. * Type I diabetes mellitus. * Presence or history of thromboembolic disorders. * Serious decompensated renal or liver disease. * Abnormal laboratory values * Any condition or disease that could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the investigational product.