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- Title
Evaluation of a Modified Pamidronate Protocol for the Treatment of Osteogenesis Imperfecta.
- Authors
Palomo, Telma; Andrade, Maria; Peters, Barbara; Reis, Fernanda; Carvalhaes, João; Glorieux, Francis; Rauch, Frank; Lazaretti-Castro, Marise; Andrade, Maria C; Peters, Barbara S E; Reis, Fernanda A; Carvalhaes, João Tomás A; Glorieux, Francis H
- Abstract
Intravenous pamidronate is widely used to treat children with osteogenesis imperfecta (OI). In a well-studied protocol ('standard protocol'), pamidronate is given at a daily dose of 1 mg per kg body weight over 4 h on 3 successive days; infusion cycles are repeated every 4 months. Here, we evaluated renal safety of a simpler protocol for intravenous pamidronate infusions (2 mg per kg body weight given in a single infusion over 2 h, repeated every 4 months; 'modified protocol'). Results of 18 patients with OI types I, III, or IV treated with the modified protocol for 12 months were compared to 18 historic controls, treated with standard protocol. In the modified protocol, mild transient post-infusion increases in serum creatinine were found during each infusion but after 12 months serum creatinine remained similar from baseline [0.40 mg/dl (SD: 0.13)] to the end of the study [0.41 mg/dl (SD: 0.11)] (P = 0.79). The two protocols led to similar changes in serum creatinine during the first pamidronate infusion [modified protocol: +2% (SD: 21%); standard protocol: -3% (SD: 8%); P = 0.32]. Areal lumbar spine bone mineral density Z-scores increased from -2.7 (SD: 1.5) to -1.8 (SD: 1.4) with the modified protocol, and from -4.1 (SD: 1.4) to -3.1 (SD: 1.1) with standard protocol (P = 0.68 for group differences in bone density Z-score changes). The modified pamidronate protocol is safe and may have similar effects on bone density as the standard pamidronate protocol. More studies are needed with longer follow-up to prove anti-fracture efficacy.
- Subjects
OSTEOGENESIS imperfecta; JUVENILE diseases; DISODIUM pamidronate; BODY weight; INTRAVENOUS therapy; MEDICAL protocols; BLOOD serum analysis; CREATININE; THERAPEUTICS; BONE fracture prevention; COMPARATIVE studies; DIPHOSPHONATES; DRUG administration; DOSE-effect relationship in pharmacology; BONE fractures; INTRAMUSCULAR injections; RESEARCH methodology; MEDICAL cooperation; RESEARCH; EVALUATION research; BONE density; RANDOMIZED controlled trials; CONTROL groups
- Publication
Calcified Tissue International, 2016, Vol 98, Issue 1, p42
- ISSN
0171-967X
- Publication type
journal article
- DOI
10.1007/s00223-015-0061-y