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Alendronate safe, effective in children, adolescents with osteogenesis imperfecta
Fracture incidence and bone turnover biomarkers decreased and lumbar spine and femoral neck bone mineral density increased with 3 years of alendronate therapy in children with osteogenesis imperfecta, according to recently published data.
Mei Li, MD, of the department of endocrinology, Key Laboratory of Endocrinology of Ministry Health, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences in Beijing, and colleagues evaluated 91 children and adolescents (62 boys) with osteogenesis imperfecta treated with 70 mg alendronate (Fosamax, Merck) weekly and 500 mg calcium daily for 3 years. Researchers sought to the determine the efficacy and safety of long-term treatment with alendronate on osteogenesis imperfecta.
Participants with osteogenesis imperfecta were diagnosed with mild (31.9%), moderate (49.4%) or severe disease (18.7%). Median age of earliest fracture was 2.3 years, and mean number of fractures at baseline was 9.5; 60.4% of participants had spine or long-bone deformities; 73% had blue sclera; 41.8% had dentinogenesis imperfecta; and 60.4% had joint hypermobility.
After treatment, the mean number of bone fractures decreased from 1.2 to 0.2 per year (P < .01). During the study, 39 fractures occurred. The mean fracture incidence decreased from 1.02 to 0.58 in participants aged 3 to 5 years (P < .05), from 1.3 to 0.3 in those aged 5 to 10 years (P < .01), from 1 to 0.1 in those aged 10 to 15 years (P < .01) and from 0.5 to 0.1 in participants aged 15 to 18 years (P < .05) in the age-stratified analysis.
Lumbar spine BMD increased by 74.6%, femoral neck BMD increased by 39.5% and total hip BMD increased by 26.7% after treatment (P < .01 for all vs. baseline). Lumbar spine BMD z score increased in participants aged 3 to 5 years (from –5.8 to –1.4; P < .05), 5 to 10 years (from –2.7 to 1.4; P < .01), 10 to 15 years (from –2.2 to –0.5; P < .01) and 15 to 18 years (from –1.6 to 0.2; P < .05) in the age-stratified analysis.
After 6 months of treatment, serum total alkaline phosphatase and cross-linked C-telopeptide of type I collagen decreased by 35.6% and by 44.3% after 3 years of treatment (P < .05 for all).
“Three years’ treatment with alendronate is demonstrated for the first time to significantly reduce fracture incidence, increase lumbar spine and femoral neck BMD and their z score, decrease bone turnover biomarkers, with good tolerance and safety in a large sample of Chinese children and adolescents with [osteogenesis imperfecta],” the researchers wrote. “Alendronate should be considered as a treatment option for children or adolescents with [osteogenesis imperfecta], even in different growth stages. The appropriate dosage and treatment course are worthy of further investigation.” – by Amber L. Cox
Disclosure: The researchers report no relevant financial disclosures.