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Alendronate for the treatment of pediatric osteogenesis imperfecta: a randomized placebo-controlled study
1Genetics Unit, Shriners Hospital for Children, 1529 Cedar Avenue, Montréal, Québec, Canada.
Insights
Daily oral alendronate (ALN) increased bone mineral density in children with osteogenesis imperfecta (OI). However, this bisphosphonate treatment did not reduce fracture incidence over two years.
Area of Science:
- Pediatric Endocrinology
- Bone Metabolism
- Pharmacological Treatments
Background:
- Limited data exists on oral bisphosphonate use for pediatric osteogenesis imperfecta (OI).
- Osteogenesis imperfecta is a genetic disorder characterized by fragile bones.
Purpose of the Study:
- To evaluate the efficacy and safety of daily oral alendronate (ALN) in children diagnosed with osteogenesis imperfecta (OI).
Main Methods:
- A multicenter, double-blind, randomized, placebo-controlled study was conducted.
- 139 children (aged 4-19 years) with OI types I, III, or IV received either placebo or ALN for two years.
- Key measurements included bone mineral density (BMD), bone turnover markers, fracture incidence, and safety parameters.
Main Results:
- Alendronate significantly increased spine areal BMD by 51% and improved the BMD z-score compared to placebo.
- Bone turnover markers, specifically urinary N-telopeptide of collagen type I, decreased significantly with ALN treatment.
- No significant differences were observed between groups in long-bone fracture incidence, bone pain, physical activity, or adverse events.
Conclusions:
- Two-year oral alendronate treatment in pediatric OI patients effectively reduced bone turnover and increased spine BMD.
- Despite positive effects on bone density and turnover, oral ALN did not demonstrate an improvement in fracture outcomes in this cohort.
Context:
Information on the use of oral bisphosphonate agents to treat pediatric osteogenesis imperfecta (OI) is limited.
Objective:
The objective of the investigation was to study the efficacy and safety of daily oral alendronate (ALN) in children with OI.
Design And Participants:
We conducted a multicenter, double-blind, randomized, placebo-controlled study. One hundred thirty-nine children (aged 4-19 yr) with type I, III, or IV OI were randomized to either placebo (n = 30) or ALN (n = 109) for 2 yr. ALN doses were 5 mg/d in children less than 40 kg and 10 mg/d for those 40 kg and greater.
Main Outcome Measures:
Spine areal bone mineral density (BMD) z-score, urinary N-telopeptide of collagen type I, extremity fracture incidence, vertebral area, iliac cortical width, bone pain, physical activity, and safety parameters were measured.
Results:
ALN increased spine areal BMD by 51% vs. a 12% increase with placebo (P < 0.001); the mean spine areal BMD z-score increased significantly from -4.6 to -3.3 (P < 0.001) with ALN, whereas the change in the placebo group (from -4.6 to -4.5) was insignificant. Urinary N-telopeptide of collagen type I decreased by 62% in the ALN-treated group, compared with 32% with placebo (P < 0.001). Long-bone fracture incidence, average midline vertebral height, iliac cortical width, bone pain, and physical activity were similar between groups. The incidences of clinical and laboratory adverse experiences were also similar between the treatment and placebo groups.
Conclusions:
Oral ALN for 2 yr in pediatric patients with OI significantly decreased bone turnover and increased spine areal BMD but was not associated with improved fracture outcomes.
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