To Assess Prevention of Bone Loss in Women With Lupus Receiving Treatment With Glucocorticoids
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
1 other identifier
interventional
155
2 countries
26
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2002
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
January 30, 2003
CompletedFirst Posted
Study publicly available on registry
February 3, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedJanuary 7, 2008
November 1, 2004
January 30, 2003
December 26, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
University of Arizona
Tucson, Arizona, 85724, United States
Wallace Rheumatic Study Center
Los Angeles, California, 90048, United States
Peng T Fan, MD & Wonil Lee, MD Partnership
North Hollywood, California, 91607, United States
Lifestyles Health Science Center
Rancho Mirage, California, 92270, United States
University of California San Diego
San Diego, California, 92093-0943, United States
East Bay Rheumatology Group
San Leandro, California, 94578, United States
Center for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, 33334, United States
Rheumatology Associates of Central Florida
Orlando, Florida, 32806-6264, United States
Tampa Medical Group, P.A.
Tampa, Florida, 33614, United States
Northwestern University
Chicago, Illinois, 60611, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
St. John's Medical Research Group
Springfield, Missouri, 65804, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
North Shore University Hospital, Division of Rheumatology
Manhasset, New York, 11030, United States
Albert Einstein Medical School
The Bronx, New York, 10461, United States
Oklahoma Center for Arthritis Therapy
Tulsa, Oklahoma, 74114, United States
Oregon Health & Science University
Portland, Oregon, 97201, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
University of Texas, Medical Branch
Galveston, Texas, 77555, United States
Sentara Medical Group DBA
Virginia Beach, Virginia, 23462, United States
Seattle Rheumatology Associates
Seattle, Washington, 98104, United States
Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z.
Mexico City, 14000, Mexico
Related Publications (1)
Sanchez-Guerrero J, Fragoso-Loyo HE, Neuwelt CM, Wallace DJ, Ginzler EM, Sherrer YR, McIlwain HH, Freeman PG, Aranow C, Petri MA, Deodhar AA, Blanton E, Manzi S, Kavanaugh A, Lisse JR, Ramsey-Goldman R, McKay JD, Kivitz AJ, Mease PJ, Winkler AE, Kahl LE, Lee AH, Furie RA, Strand CV, Lou L, Ahmed M, Quarles B, Schwartz KE. Effects of prasterone on bone mineral density in women with active systemic lupus erythematosus receiving chronic glucocorticoid therapy. J Rheumatol. 2008 Aug;35(8):1567-75. Epub 2008 Jul 15.
PMID: 18634158DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 30, 2003
First Posted
February 3, 2003
Study Start
December 1, 2002
Study Completion
August 1, 2004
Last Updated
January 7, 2008
Record last verified: 2004-11