Network Osteoporosis Study (NCT00209469) | Clinical Trial Compass
UnknownPhase 2/3
Network Osteoporosis Study
United States90 participantsStarted 2002-07
Plain-language summary
This study is evaluating the use of the drug alendronate in preventing or reversing bone loss in children and adolescents receiving steroid medications.
Who can participate
Age range8 Years – 22 Years
SexALL
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Inclusion Criteria:
* Subjects must be diagnosed with either ulcerative colitis, Crohn's disease, systemic-onset juvenile rheumatoid arthritis, juvenile dermatomyositis, systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD) or vasculitis according to standard criteria where available, and according to treating physicians when not available.
* Subjects must have diminished AP lumbar spine (L1-L4) BMD by DXA (Hologic 4500) with a Z score ≤ -1.5 SD assessed within 8 weeks of the Baseline Visit.
* Subjects must have received daily, alternate day or weekly systemic glucocorticoid therapy for a minimum of six months total in their life-time.
* Subjects must be between the ages of 8 and 21 years, 11 months, at randomization. Although subjects younger than 8 years of age may be affected by osteoporosis, limited normative data prevents assignment of a BMD Z score for this group. Subjects through 21 years, 11 months will be included because many individuals with chronic disorders will have an immature skeleton, and even in healthy individuals there is significant accrual of bone mass into the 20's, making this a dynamic and critical time period for analysis.
* Females who have had at least one menstrual cycle must either be abstinent or must be using an effective method of birth control (e.g. intrauterine contraceptive device, oral contraceptive, diaphragm or condom with contraceptive jelly, cream, or foam). This will be documented at each visit. Additionally, the…
What they're measuring
1
Mean change of individual AP spine BMD (gm/cm2) determined by dual energy X-ray absorptiometry (DXA) at 6, 12,18, 24 and 30 Months.