J Clin Endocrinol Metab: Zoledronic acid versus placebo in pediatric glucocorticoid-induced osteoporosis

Glucocorticoid (GC) therapy is the cornerstone of the treatment of many pediatric diseases, including inflammatory or autoimmune diseases, and Duchenne muscular dystrophy (DMD)
.
However, GC increases the risk of fragility fractures, especially in the spine where trabecular bone is abundant

Although intravenous (IV) bisphosphonates are the most commonly used drugs for the treatment of primary and secondary osteoporosis in children, to date there has been no evidence of bone fragility (osteoporosis) in any pediatric population.
Randomized, placebo-controlled trials of these drugs

Intravenous zoledronic acid (IVZA) is approved globally for the treatment of osteoporosis caused by GC in men, postmenopausal women, adults, and to prevent future fractures in adults with a history of low trauma hip fractures
.
Historically, intravenous pamidronate has been the most frequently used bisphosphonate in children; however, in recent years, due to the use of ZA in adults, the shorter infusion time and the More time has attracted people's attention

A retrospective observational study of IVZA in children with GC-treated disease and fragility fractures showed increases in bone mineral density parameters and no new VF
.
Taken together, these uncontrolled observations suggest that IVZA may be useful in GC-treated children with VFS, a key manifestation of GC-related bone fragility

Considering the results of these studies, we aimed to formally evaluate the efficacy and safety of intravenous ZA in the treatment of fragility fractures in children using a randomized, double-blind, intravenous placebo-controlled design
.

Methods: Children 5 to 17 years of age with gastroenteritis participated in this multinational, randomized, double-blind, placebo-controlled phase 3 trial
.
Eligible children were randomly assigned to receive intravenous ZA 0.

Results: Thirty-four children were enrolled, with a mean age of (12.
6±3.
4) years [18 in the ZA group and 16 in the placebo group], all with low trauma vertebral fractures (VFS)
.
ZA group − was 2.

To our knowledge, this is the first randomized, placebo-controlled trial of intravenous bisphosphonates in children with bone fragility
.
We have shown that children with VFS treated with GC at 0.

Source: Ward LM, Choudhury A, Alos N, Zoledronic Acid vs Placebo in Pediatric Glucocorticoid-induced Osteoporosis: A Randomized, Double-blind, Phase 3 Trial, J Clin Endocrinol Metab 2021 Jul 06;