Systemic Lupus Erythematosus
Conditions
Keywords
Lupus, Systemic Lupus Erythematosus, SLE, Bone Loss, DHEA
Brief summary
Open label safety and efficacy follow-up.
Detailed description
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.
Interventions
There were 4 arms to the study: During a previous 6 month db RCT, patients received either prasterone 200 mg/day or placebo. Upon entry into this open-label study, they were re-assigned by randomized allocation to receive either prasterone 200 mg/day or 100 mg/day. Hence, there were 4 possible treatment arms extending over the 18 months of observation between the double-blind study and the subsequent 12 month open-label extension study.
Sponsors
Genelabs Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids. | 12 months |
Countries
Mexico, United States
Outcome results
None listed