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

Sponsor

Genelabs Technologies (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00053560

Collaborator

(none)

155

Enrollment

Locations

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Lupus	Drug: Prasterone (GL701)	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

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

Study Start Date :

Dec 1, 2002

Study Completion Date :

Aug 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85724
2	Wallace Rheumatic Study Center	Los Angeles	California	United States	90048
3	Peng T Fan, MD & Wonil Lee, MD Partnership	North Hollywood	California	United States	91607
4	Lifestyles Health Science Center	Rancho Mirage	California	United States	92270
5	University of California San Diego	San Diego	California	United States	92093-0943
6	East Bay Rheumatology Group	San Leandro	California	United States	94578
7	Center for Rheumatology, Immunology and Arthritis	Fort Lauderdale	Florida	United States	33334
8	Rheumatology Associates of Central Florida	Orlando	Florida	United States	32806-6264
9	Tampa Medical Group, P.A.	Tampa	Florida	United States	33614
10	Northwestern University	Chicago	Illinois	United States	60611
11	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
12	Johns Hopkins University	Baltimore	Maryland	United States	21205
13	St. John's Medical Research Group	Springfield	Missouri	United States	65804
14	Washington University School of Medicine	St. Louis	Missouri	United States	63110
15	Albert Einstein Medical School	Bronx	New York	United States	10461
16	SUNY Downstate Medical Center	Brooklyn	New York	United States	11203
17	North Shore University Hospital, Division of Rheumatology	Manhasset	New York	United States	11030
18	Oklahoma Center for Arthritis Therapy	Tulsa	Oklahoma	United States	74114
19	Oregon Health & Science University	Portland	Oregon	United States	97201
20	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
21	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15261
22	Vanderbilt University	Nashville	Tennessee	United States	37232
23	University of Texas, Medical Branch	Galveston	Texas	United States	77555
24	Sentara Medical Group DBA	Virginia Beach	Virginia	United States	23462
25	Seattle Rheumatology Associates	Seattle	Washington	United States	98104
26	Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z.	Mexico City		Mexico	14000