Clinical trial NCT00053560: To Assess Prevention of Bone Loss in Women With Lupus Receiving Treatment With Glucocorticoids
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lupus
Keywords: lupus
systemic lupus erythematosus
SLE
bone loss
DHEA
Lead sponsor: Genelabs Technologies
Sponsor class: INDUSTRY
First posted: 2003-02-03
Enrollment: 155
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility 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.

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