To Assess Prevention of Bone Loss in Women With Lupus Receiving Treatment With Glucocorticoids

INCLUSION CRITERIA

• Women at least 18 years of age.
• Meet ACR criteria for diagnosis of SLE.
• Concomitant treatment with prednisone at a dose of ≥5 mg/day over the last 30 days prior to Screening visit.
• Cumulative history of oral glucocorticoid use for at least 6 months over the last year prior to the Screening Visit (the 6 months do not have to be consecutive).
• Patient has lumbar spine and proximal femur anatomy suitable for measurement by DXA with at least 3 evaluable vertebrae from L1 to L4.
• SLEDAI ≥3 at the Qualifying Visit.
• Women of child-bearing potential must have a negative serum pregnancy test (at the Screening Visit) and agree to use a reliable form of birth control while participating in the study.
• Patient is fully ambulatory.
• Patient has read and signed an Informed Consent Form.

EXCLUSION CRITERIA

• History of breast cancer or malignancy of the reproductive tract organs.
• History of any other cancers unless no evidence of disease for 5 years.
• History of endometrial hyperplasia.
• End stage renal disease or receiving hemodialysis treatment.
• Any disease or condition that would preclude the accurate measurement of bone mineral density of the lumbar spine or proximal femur by dual X-ray absorptiometry.
• A T-score of less than or equal to - 2.5 of the L-spine or proximal femur at Screening DXA assessment.
• Unstable cardiac disease.
• Conditions causing bone loss such as hyperparathyroidism, Cushing's disease, thyrotoxicosis, chronic diarrheal state or malabsorption, renal tubular acidosis, or anorexia nervosa.
• Significant hepatic disease (i.e., cirrhosis).
• Body mass index > 35 kg/m2 or weight >300 lbs.
• Patients who are pregnant or breast feeding.
• Patients who require glucocorticoids by an alternate day dosing schedule.
• Known hypersensitivity to DHEA, or the inactive ingredients used in the GL701 formulation (cornstarch, lactose, magnesium stearate).
• Known medical contraindication or hypersensitivity to Calcium/Vitamin D.
• Participation in any prior DHEA or GL701 study.
• Use of investigational agents within 30 days of the Screening Visit or 10 half-lives of the agent.
• 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).
• The patient is taking or has taken one of the medications listed below:

ANTIRESORPTIVES:

• Use of calcitonin within 30 days prior to Screening Visit.
• Fluorides > 1 mg/day at any time prior to the study.
• Strontium at pharmacologic dose at any time.

BISPHOSPHONATE USE as follows:

• Any use within 90 days prior to the Screening Visit.
• ≥ 2 weeks of use in the last year prior to the Screening Visit.
• ≥ 3 months of use in the last 2 years prior to the Screening Visit.
• ≥ 1 intravenous dose over the last 2 years prior to the Screening Visit.
• ≥ 6 months of life-time exposure prior to the Screening Visit.

ESTROGENIC STEROIDS (Except for oral contraceptives):

• Estrogenic steroids (HRT) within 60 days of the Screening Visit.
• Selective estrogen receptor modulator (raloxifene) within 60 days of the Screening Visit.

OTHER HORMONES:

• Parathyroid hormone (PTH) within six months of the Screening Visit.
• Use of any androgens, including prescription or nutritional supplement DHEA, within 30 days of the Screening Visit.