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

Lupus Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00053560
• Other study ID #: GL02-01
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 30, 2003
• Last updated: December 26, 2007
• Start date: December 2002
• Est. completion date: August 2004

Study information

• Verified date: November 2004
• Source: Genelabs Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 155
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lupus
• Lupus Erythematosus, Systemic

Intervention

Drug:
• Prasterone (GL701)

Locations

Country	Name	City	State
Mexico	Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z.	Mexico City
United States	Johns Hopkins University	Baltimore	Maryland
United States	Albert Einstein Medical School	Bronx	New York
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Northwestern University	Chicago	Illinois
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Center for Rheumatology, Immunology and Arthritis	Fort Lauderdale	Florida
United States	University of Texas, Medical Branch	Galveston	Texas
United States	Wallace Rheumatic Study Center	Los Angeles	California
United States	North Shore University Hospital, Division of Rheumatology	Manhasset	New York
United States	Vanderbilt University	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Peng T Fan, MD & Wonil Lee, MD Partnership	North Hollywood	California
United States	Rheumatology Associates of Central Florida	Orlando	Florida
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
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	Seattle Rheumatology Associates	Seattle	Washington
United States	St. John's Medical Research Group	Springfield	Missouri
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Tampa Medical Group, P.A.	Tampa	Florida
United States	University of Arizona	Tucson	Arizona
United States	Oklahoma Center for Arthritis Therapy	Tulsa	Oklahoma
United States	Sentara Medical Group DBA	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Genelabs Technologies

Countries where clinical trial is conducted

United States,  Mexico,