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

Status unconfirmed · Phase 3

Conditions studied: Lupus

In brief

The purpose of this clinical trial is to study the effects of GL701 on bone mineral density in women with active systemic lupus erythematosus (SLE) who are also receiving treatment with glucocorticoids (e.g., prednisone).

Key facts

Study ID

NCT00053560

Run by

Genelabs Technologies

People needed

155

Starts

2002-12-01

Expected to finish

2004-08-01

Last updated by the study team

2008-01-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Arizona — Tucson, Arizona, United States
• Wallace Rheumatic Study Center — Los Angeles, California, United States
• Peng T Fan, MD & Wonil Lee, MD Partnership — North Hollywood, California, United States
• Lifestyles Health Science Center — Rancho Mirage, California, United States
• University of California San Diego — San Diego, California, United States
• East Bay Rheumatology Group — San Leandro, California, United States
• Center for Rheumatology, Immunology and Arthritis — Fort Lauderdale, Florida, United States
• Rheumatology Associates of Central Florida — Orlando, Florida, United States
• Tampa Medical Group, P.A. — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• St. John's Medical Research Group — Springfield, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• SUNY Downstate Medical Center — Brooklyn, New York, United States
• North Shore University Hospital, Division of Rheumatology — Manhasset, New York, United States
• Albert Einstein Medical School — The Bronx, New York, United States
• Oklahoma Center for Arthritis Therapy — Tulsa, Oklahoma, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• University of Texas, Medical Branch — Galveston, Texas, United States
• Sentara Medical Group DBA — Virginia Beach, Virginia, United States
• Seattle Rheumatology Associates — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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