Safety and efficacy of a 1-year treatment with zoledronic acid compared with pamidronate in children with osteogenesis imperfecta

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dc.contributor.author Barros, Elizabete Ribeiro [UNIFESP]
dc.contributor.author Saraiva, Gabriela L. [UNIFESP]
dc.contributor.author Oliveira, Telma Palomo de [UNIFESP]
dc.contributor.author Lazaretti-Castro, Marise [UNIFESP]
dc.date.accessioned 2016-01-24T14:27:21Z
dc.date.available 2016-01-24T14:27:21Z
dc.date.issued 2012-06-01
dc.identifier http://dx.doi.org/10.1515/jpem-2012-0016
dc.identifier.citation Journal of Pediatric Endocrinology & Metabolism. Berlin: Walter de Gruyter & Co, v. 25, n. 5-6, p. 485-491, 2012.
dc.identifier.issn 0334-018X
dc.identifier.uri http://repositorio.unifesp.br/handle/11600/34982
dc.description.abstract Pamidronate (PAM) infusion is the standard treatment in children with osteogenesis imperfecta (OI). Zoledronic acid (ZOL) is a bisphosphonate with higher potency and faster intravenous infusion, but its efficacy and safety has not been established for OI patients. We report an open-label, prospective, and randomized clinical analysis to study the safety and efficacy of ZOL compared with PAM in 23 children with OI. They were selected to receive PAM (PAM group), 1 mg/kg/day, over 2 days or ZOL (ZOL group), 0.025-0.05 mg/kg/day, over 2 days every 3-4 months according to their ages, during a 1-year follow-up. They were observed for clinical and biochemical parameters, side effects, bone mineral density (BMD), and fracture rate. After treatment, the PAM and ZOL groups average lumbar spine (LS) BMD increased by 51.8% (p=0.053) and 67.6% (p=0.003), respectively. Parallel improvement was seen in LS Z-score in the PAM and ZOL groups, with scores of -5.3 to -3.8 (p=0.032) and -4.8 to -2.3 (p=0.007), respectively. LS Z-score for the ZOL group at the end of treatment was higher compared with the PAM group but only a borderline significance (p=0.053). the total alkaline phosphatase (AP) in the ZOL group significantly decreased from baseline at third and fourth infusion (p=0.032). Mild side effects were similar in both groups, but no severe clinical symptoms were reported. in conclusion, the present study shows that the use of ZOL in the dosage and period studied was safe and efficient to promote a clinical and densitometric improvement, similarly to PAM. Further studies are needed to establish optimal dosing and long-term safety. en
dc.format.extent 485-491
dc.language.iso eng
dc.publisher Walter de Gruyter & Co
dc.relation.ispartof Journal of Pediatric Endocrinology & Metabolism
dc.rights Acesso restrito
dc.subject BMD en
dc.subject efficacy en
dc.subject osteogenesis imperfecta en
dc.subject pamidronate en
dc.subject zoledronic acid en
dc.title Safety and efficacy of a 1-year treatment with zoledronic acid compared with pamidronate in children with osteogenesis imperfecta en
dc.type Artigo
dc.contributor.institution Universidade Federal de São Paulo (UNIFESP)
dc.description.affiliation Universidade Federal de São Paulo, Div Endocrinol, Bone & Mineral Unit, São Paulo, Brazil
dc.description.affiliationUnifesp Universidade Federal de São Paulo, Div Endocrinol, Bone & Mineral Unit, São Paulo, Brazil
dc.identifier.doi 10.1515/jpem-2012-0016
dc.description.source Web of Science
dc.identifier.wos WOS:000309754800014



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