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Effect of pamidronate on bone loss after kidney transplantation: a randomized trial
Stephen B Walsh1, Paul Altmann, James Pattison
1The Centre for Nephrology, Royal Free Hospital, London, UK. stephen.walsh@ucl.ac.uk
Background:
Kidney transplantation is associated with an increased risk of bone fracture and rapid loss of bone mineral density after kidney transplantation.
Study Design:
Randomized controlled trial.
Setting & Participants:
Patients were randomly assigned to treatment (n = 46) or control (no treatment; n = 47) groups. Patients were stratified according to parathyroid hormone level and sex. Those with parathyroid hormone level less than 150 pg/mL were excluded.
Intervention:
The treatment and control groups received pamidronate, 1 mg/kg, perioperatively and then at 1, 4, 8, and 12 months or no treatment, respectively. All received calcium (500 mg) and vitamin D (400 units) daily. Immunosuppression was cyclosporine and prednisolone, with no difference in dosing between the 2 groups.
Outcomes & Measurements:
Bone mineral density was evaluated by means of dual-energy x-ray absorptiometry of the lumbar spine and hip at baseline and 3, 6, 12, and 24 months, with the primary end point at 1 year of percentage of change in bone mineral density from baseline. Clinical fractures were recorded and also evaluated by means of spinal radiographs at baseline and 1 and 2 years.
Results:
Pamidronate protected bone mineral density at the lumbar spine; bone mineral density increased by 2.1% in the treatment group and decreased by 5.7% in the control group at 12 months (P = 0.001). Protection was also seen in Ward's area of the hip (P = 0.002) and the total hip (P = 0.004). There was no difference in femoral neck bone mineral density loss between the 2 groups. Fracture rates in the treatment and control groups were 3.3% and 6.4% per annum, respectively.
Limitations:
This study was not powered to detect differences in fracture rates.
Conclusion:
Pamidronate protects against posttransplantation bone loss at the lumbar spine and Ward's area of the hip.
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