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

This is an interventional treatment trial for Osteopenia Read More

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.