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
Data Collection
Autoimmune Diseases+7
+ Bone Diseases
+ Bone Diseases, Metabolic
Treatment Study
Summary
Study start date: July 1, 2003
Actual date on which the first participant was enrolled.This was a randomized, multi-center, open-label, parallel-group, trial of prasterone 200 or 100 mg/day for 12 months in women with lupus receiving glucocorticoid therapy who had completed an earlier 6-month randomized, placebo-controlled study (NCT00053560. Bone Mineral Density assessments were performed at baseline and at months 6 and 12.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.114 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 22 locations
Wallace Rheumatic Study Center
Los Angeles, United StatesLifestyles Health Science Center
Rancho Mirage, United StatesUniversity of California San Diego
San Diego, United States