Clinical trial NCT00082511: GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
Official title: A Multi-Center, Open-Label Study to Assess the Durability and Safety of the Prevention of Bone Loss by Treatment With GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Systemic Lupus Erythematosus
SLE
Bone Loss
DHEA
Lead sponsor: Genelabs Technologies
Sponsor class: INDUSTRY
First posted: 2004-07-16
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Open label safety and efficacy follow-up.

Detailed description: This was a randomized, multi-center, open-label, parallel-group, trial of prasterone 200 or 100 mg/day for 12 months in women with lupus receiving glucocorticoid therapy who had completed an earlier 6-month randomized, placebo-controlled study (NCT00053560. Bone Mineral Density assessments were performed at baseline and at months 6 and 12.

Eligibility criteria: Inclusion Criteria:

* Patient has completed the full 6 month treatment period with study drug in the previous Genelabs' clinical study GL02-01.
* Concomitant treatment with prednisone (or equivalent) at a dose of ≥ 5mg/day.
* Patient has read and signed an Informed Consent Form. If the patient is not fluent in English, the Informed Consent must be signed in her native language.

Exclusion Criteria:

* Patient has had a serious study drug related adverse reaction at any time during the previous GL02-01 study.
* 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).

MEDICATIONS PROHIBITED AT ANY TIME DURING THE STUDY

* Calcitonin
* Bisphosphonates
* Fluoride at pharmacologic dose
* Strontium at pharmacologic dose
* Estrogenic steroids (except oral contraceptives)
* Selective Estrogen Receptor Modulator (raloxifene)
* Parathyroid hormone
* Any androgens, including prescription or nutritional supplement DHEA, other than study drug
* Additional Calcium supplements other than those prescribed as part of this study

Primary outcomes:
measure: Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids.
timeFrame: 12 months
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: 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: 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: 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.