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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00053560
• Date of registration: 30/01/2003
• Prospective Registration: No
• Primary sponsor: Genelabs Technologies
• Public title: To Assess Prevention of Bone Loss in Women With Lupus Receiving Treatment With Glucocorticoids
• Scientific title: A Randomized, Double-Blind, Multi-Center, Placebo- Controlled Study to Assess Prevention of Bone Loss by Treatment With GL701 (Prestara) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
• Date of first enrolment: December 2002
• Target sample size: 155
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00053560
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

Mexico, United States

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Lupus

Intervention(s)

Drug: Prasterone (GL701)

Secondary ID(s)

GL02-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors