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Home > "T" Clinical Trials Conditions > To assess prevention of bone loss in women with lupus receiving treatment with glucocorticoids  To assess prevention of bone loss in women with lupus receiving treatment with glucocorticoids
To assess prevention of bone loss in women with lupus receiving treatment with glucocorticoids
For Condition: Lupus
Status: No longer recruiting
Sponsor(s): Genelabs Technologies ,
Synopsis: The purpose of this clinical trial is to study the effects of GL701 (which contains DHEA, a mild androgenic hormone, as its active ingredient) on bone mineral density in women with active systemic lupus erythematosus (SLE) who are also receiving treatment with glucocorticoids (e.g., prednisone).
Details:
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry 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.
Total Enrollment: 154
Location and Contact Information:
Wallace Rheumatic Study Center
Los Angeles, California, 90048
United States
Johns Hopkins University
Baltimore, Maryland, 21205
United States
University of California San Diego
San Diego, California, 92093-0943
United States
Northwestern University
Chicago, Illinois, 60611
United States
Lifestyles Health Science Center
Rancho Mirage, California, 92270
United States
Vanderbilt University
Nashville, Tennessee, 37232
United States
Center for Rheumatology, Immunology and Arthritis
Ft. Lauderdale, Florida, 33334
United States
Oklahoma Center for Arthritis Therapy
Tulsa, Oklahoma, 74114
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
United States
Sentara Medical Group DBA
Virginia Beach, Virginia, 23462
United States
University of Arizona
Tucson, Arizona, 85724
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
University of Texas, Medical Branch
Galveston, Texas, 77555
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Tampa Medical Group, P.A.
Tampa, Florida, 33614
United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
United States
Albert Einstein Medical School
Bronx, New York, 10461
United States
East Bay Rheumatology Group
San Leandro, California, 94578
United States
Oregon Health & Science University
Portland, Oregon, 97201
United States
North Shore University Hospital, Division of Rheumatology
Manhasset, New York, 11030
United States
St. John's Medical Research Group
Springfield, Missouri, 65804
United States
Seattle Rheumatology Associates
Seattle, Washington, 98104
United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203
United States
Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z.
Mexico City, , 14000
Mexico
Peng T Fan, MD & Wonil Lee, MD Partnership
North Hollywood, California, 91607
United States
Rheumatology Associates of Central Florida
Orlando, Florida, 32806-6264
United States
Additional Information:
Study ID Numbers: GL02-01;
Study Start Date: December 2002
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053560
Other Lupus Studies:
1. Prevention of Atherosclerosis and Heart Disease in Patients with Systemic Lupus Erythematosis (SLE)
2. Improving Quality of Life for African American Female Adolescents With Lupus
3. To assess prevention of bone loss in women with lupus receiving treatment with glucocorticoids
Related Studies:
Other Lupus Clinical Trials
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Other Chicago Clinical Trials
To assess prevention of bone loss in women with lupus receiving treatment with glucocorticoids
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