Using pamidronate in patients with CP undergoing hip surgery.

• Research type

  Research Study

• Full title

  The effect of pamidronate treatment on bone health in patients with neuromuscular disease undergoing hip surgery.

• IRAS ID

  8842

• Sponsor organisation

  Central Manchester and Manchester University Children's Hospital NHS Trust.

• Eudract number

  2009-013777-17

• Research summary

  Hip dislocations in children with neuromuscular conditions are common and can cause a number of problems, including pain, difficulty with personal hygiene, skin ulcer formation, sitting imbalance and mobilisation problems in ambulant patients. With growth, persistent deformities develop around the hip and extensive surgical procedures may be required. Surgery is followed by a period of immobilisation either in a hip spica or broomstick plasters in order to allow time for the bones to heal.The post-operative immobilisation of these children results in reduction in bone strength. It is well reported that patients with cerebral palsy undergoing hip surgery followed by post-operative immobilisation are likely to sustain fractures causing them pain and disruption in their everyday activities and post-operative physiotherapy regime.Bisphosphonate and in particular pamidronate treatment may be beneficial in maintaining bone strength at the end of plaster immobilisation and thus reduce the incidence of post-operative fractures. Bisphosphonates are drugs shown to improve bone strength in patients with osteoporosis. Bisphosphonates have not been known to have any long term side effects in children. Short term side effects may include pyrexia, nausea, musculoskeletal aches and transient neutropenia. Considering there is no definite evidence at the time being, our current protocol for children with neuromuscular conditions requiring surgery at Royal Manchester Children??s Hospital does NOT include bisphosphonate prophylactic treatment.In our proposed study children will be randomized in either a treatment group receiving intravenous bisphosphonate for three consecutive days 2 weeks prior to surgery and a placebo group receiving intravenous saline rather than pamidronate. The bone strength will be measured using special scans.If it is found that bisphosphonate treatment is beneficial in maintaining bone strength, this may lead to a change in our current treatment protocol and a more widespread usage of bisphosphonate treatment.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  09/H1008/105

• Date of REC Opinion

  22 Sep 2009

• REC opinion

  Further Information Favourable Opinion