Children With Osteoporosis Respond To Treatment With Bisphosphonates
Doctor's Guide November 15, 1999
By Maria Bishop
BOSTON, MA -- November 15, 1999 -- Treatment of secondary osteoporosis with bisphosphonates is well established in adults, but clinical studies in children have been limited and have raised concerns about both efficacy and long- and short-term safety. At the 63rd Annual Scientific Meeting of the American College of Rheumatology (ACR) in Boston, MA, however, it was noted that alendronate can be safely administered even in pediatric patients-significantly improving bone mass in children or teenagers with rheumatic diseases and secondary osteoporosis.
Dr. Rolando Cimaz, an active member of the pediatrics department at the University of Milan, in Italy, described an open-label, multi-center Italian study for which he was an investigator. The study population comprised 43 youths; the mean age was 13, with the youngest participant at age five. All of the participants were severely affected by osteoporosis; most were diagnosed with juvenile arthritis, lupus, dermatomyositis and other chronic inflammatory diseases, for which osteoporosis is a frequent complication. (In addition, corticosteroids are widely used to treat such patients, greatly increasing the incidence of secondary osteoporosis as a result of therapy.)
Results of the trial, stated Dr. Cimaz, were impressive. All patients received either 5 or 10 mg daily of alendronate for one year, and all showed improvement in lumbar-spine bone mineral density (BMD) as measured by sensitive, dual-energy x-ray absorptiometry (DEXA) scans. The average BMD increase was 14 percent (compared to only 1 percent in the same group of patients in the year preceding alendronate treatment). Noted Dr. Cimaz, "Generally, the average, healthy, pre-pubertal child shows a 3-6 percent BMD gain annually." After one year, one-third of the patients in this study were able to reach a normal BMD value for their age.
In the short term (one year), this trial showed that alendronate was very well tolerated in the pediatric age group. The main side effect was gastrointestinal toxicity (three patients), but this was not severe enough to cause permanent discontinuation in the trial. Results on long-term toxicity remain to be determined and are still a serious concern.
Secondary osteoporosis in children and adolescents can cause bone-fragility fractures and decreased bone mass, at a young age, may also have a deleterious effect on bones later in life that can be irreversible.
Follow-up studies on alendronate in the pediatric population will be needed to determine whether children treated with alendronate will continue to increase their BMDs or even maintain increases after therapy is discontinued.
Copyright © 1999 P\S\L Consulting Group Inc.
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