Risedronate has been found effective in reduction of fractures in osteogenesis imperfecta or brittle bone disease, a new study has reported.
The study by Bishop and colleagues has been published online on Aug 6, 2013 the journal The Lancet.
This is the first study to clearly demonstrate that the use of the risedronate can not only reduce the risk of fracture in children with brittle bones. The drug is also said to have a very rapid action — the curves for fracture risk begin to diverge after only 6 weeks of treatment.
Children with osteogenesis imperfecta are often treated with intravenous injections of bisphosphonates.
The study included 147 children with osteogenesis imperfecta and increased fracture risk aged 4-15 years where effect of risedronate was studied.
The study done was is multicentre, randomised, parallel, double-blind, placebo-controlled trial where the children were randomly assigned by telephone randomisation system in a 2:1 ratio to receive either daily risedronate (2·5 or 5 mg) or placebo for 1 year.
Patients, investigators, and study center personnel were aware the randomization and the type of drugs being given.
Following this one year therapy, all children received risedronate for 2 additional years in an open-label extension.
The efficacy was judged by percentage change in lumbar spine areal bone mineral density at 1 year.
Of 147 patients, 97 were randomly assigned to the risedronate group and 50 to the placebo group.
Four patients did not complete the treatment 3 from riserdronate group and one from placebo, leaving 94 and 49 respectively.
The mean increase in lumbar spine areal bone mineral density after 1 year was 16·3% in the risedronate group and 7·6% in the placebo group.
Clinical fractures had occurred in 29 (31%) of 94 patients in the risedronate group and 24 (49%) of 49 patients in the placebo group .
During next two yeras(open-label phase where every child received risedronate), clinical fractures were reported in 53% in the group that had received risedronate since the start of the study, and 65% patients in the group that had been given placebo during the first year.
Both the groups were found to have similar adverse event like upper-gastrointestinal and selected musculoskeletal problems.
The authors concluded that oral risedronate increased areal bone mineral density and reduced the risk of first and recurrent clinical fractures in children with osteogenesis imperfecta, and the drug was generally well tolerated.
They recommended risedronate as a treatment option for children with osteogenesis imperfecta.
Osteogenesis imperfecta is the most common heritable bone disease. Bisphosphonates are an established treatment for osteoporosis in adults. Hitherto, bisphosphnates used were given through intravenous route. This new finding with oral risedronate seems promising but needs further research.
Source & Reference
- Sheffield University News
- Nick Bishop, Silvano Adami, S Faisal Ahmed, Jordi Antón, Paul Arundel, Christine P Burren, Jean-Pierre Devogelaer, Thomas Hangartner, Eva Hosszú, Joseph M Lane, Roman Lorenc, Outi Mäkitie, Craig F Munns, Ana Paredes, Helene Pavlov, Horacio Plotkin, Cathleen L Raggio, Maria Loreto Reyes, Eckhard Schoenau, Oliver Semler, David O Sillence, Robert D Steiner. Risedronate in children with osteogenesis imperfecta: a randomised, double-blind, placebo-controlled trial. The Lancet, 2013; DOI: 10.1016/S0140-6736(13)61091-0
Image Credit : Wikipedia
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