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Benefit of infusions with ibandronate treatment in children with osteogenesis imperfecta
Mei Li1, Wei-Bo Xia, Xiao-Ping Xing
1Department of Endocrinology, Endocrine Key Laboratory of the Ministry of Health of China, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China. limeilzh@sina.com
Insights
Ibandronate significantly reduced fracture rates and improved bone mineral density in children with Osteogenesis Imperfecta (OI). This bisphosphonate treatment offers a promising therapeutic option for this rare bone disorder.
Area of Science:
- Pediatric Endocrinology
- Bone Metabolism and Disease
- Pharmacological Treatments for Rare Diseases
Background:
- Osteogenesis Imperfecta (OI) is a rare genetic bone fragility disorder with limited effective treatment options.
- Current therapeutic strategies for OI often have deficiencies in addressing bone fragility and fracture risk.
Purpose of the Study:
- To evaluate the efficacy and safety of a novel bisphosphonate, ibandronate, in pediatric patients diagnosed with Osteogenesis Imperfecta.
- To compare the effects of ibandronate treatment against calcitriol in improving bone health markers in children with OI.
Main Methods:
- An open-label, prospective, controlled study involving 30 children with OI.
- Participants received either intravenous ibandronate (2 mg every three months) or oral calcitriol (0.25 µg daily) for 24 months, with calcium and vitamin D supplementation for all.
- Key endpoints included annual fracture rate, bone mineral density (BMD), serum carboxy-telopeptide cross-links of type I collagen (CTX), and alkaline phosphatase (ALP).
Main Results:
- Ibandronate significantly reduced the annual fracture rate from 1.9 to 0.13, compared to a decrease from 1.8 to 1.0 in the calcitriol group (P < 0.001).
- Significant increases in BMD were observed in the ibandronate group at the lumbar spine (59.0%), femoral neck (42.0%), trochanter (47.5%), and total hip (36.6%) (P < 0.001), exceeding those in the calcitriol group.
- Ibandronate treatment led to significant reductions in bone resorption marker CTX and bone formation marker ALP. The drug was well-tolerated, with mild, transient side effects in some patients.
Conclusions:
- Cyclic infusions of ibandronate demonstrate significant benefits in children with OI, including a marked reduction in fracture incidence.
- Ibandronate effectively increases bone mineral density at key skeletal sites and helps preserve vertebral structure by inhibiting bone resorption.
- Ibandronate represents a promising therapeutic agent for managing Osteogenesis Imperfecta in pediatric populations.
Background:
Osteogenesis imperfecta (OI) is a rare bone disease and its effective treatment is relatively deficient. We tried to assess the effects of new bisphosphonate, ibandronate on children with OI.
Methods:
In this open-label, prospective, controlled study, 30 children with OI were enrolled. They received either infusions of ibandronate (2 mg) in every three months or oral calcitriol 0.25 µg daily for 24 months. All patients took 500 mg calcium plus 200 U vitamin D daily together. The endpoints were the change of annual new fracture rate (observed by case history and X ray films of spine), bone mineral density (BMD, measured by dual energy X-ray absortiometry), serum concentration of carboxy-telopeptide cross-links of type I collagen (CTX, bone resorption marker) and alkaline phosphatase (ALP, bone formation marker) during the follow-up.
Results:
After the cyclic infusions of ibandronate, the annual new fracture rate was significantly decreased from 1.9 to 0.13 time, obviously lower than that of calcitriol group, which decreased from 1.8 to 1.0 time after the treatment (P < 0.001). The significant increase of BMD at the lumbar spine, femoral neck, trochanter, total hip was found in the group of ibandronate by 59.0%, 42.0%, 47.5% and 36.6% in time dependent manner (compared with the baseline, P < 0.001). The increase of BMD in ibandronate group was greater than that of calcitriol group (P < 0.001). The concentrations of ALP and CTX were obviously decreased in ibandronate group, and the reduction of CTX was more significant than that of ALP (P < 0.001). The tolerance of the children to ibandronate was quite well. Mild fever and muscle pain were found in 9 cases within 1 - 3 days after the first infusion of ibandronate, which could relieve after 1 - 2 days without special management.
Conclusions:
The benefits of cyclic infusions of ibandronate to children with OI are significant because ibandronate could significantly reduce annual bone fracture rate, increase lumbar and hip BMD, preserve vertebral morphometry of patients through inhibition of bone resorption.
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