A Multi-Center, Open-Label Study to Assess the Durability and Safety of the Prevention of Bone Loss by Treatment With GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids

Date de début de l'étude : 1 juillet 2003

Inclusion Criteria: * Patient has completed the full 6 month treatment period with study drug in the previous Genelabs' clinical study GL02-01. * Concomitant treatment with prednisone (or equivalent) at a dose of ≥ 5mg/day. * Patient has read and signed an Informed Consent Form. If the patient is not fluent in English, the Informed Consent must be signed in her native language. Exclusion Criteria: * Patient has had a serious study drug related adverse reaction at any time during the previous GL02-01 study. * Any condition which in the Investigator's or Sponsor's opinion is sufficient to prevent adequate compliance with the study or likely to confuse follow-up evaluation (e.g., alcoholism, drug addiction, acute withdrawal from chemical dependency, psychiatric disease). MEDICATIONS PROHIBITED AT ANY TIME DURING THE STUDY * Calcitonin * Bisphosphonates * Fluoride at pharmacologic dose * Strontium at pharmacologic dose * Estrogenic steroids (except oral contraceptives) * Selective Estrogen Receptor Modulator (raloxifene) * Parathyroid hormone * Any androgens, including prescription or nutritional supplement DHEA, other than study drug * Additional Calcium supplements other than those prescribed as part of this study