BACKGROUND: Kidney transplantation is associated with an increased risk of bone fracture and rapid loss of bone mineral densityafter 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.
RCT Entities:
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.
Authors: Antoine Bouquegneau; Syrazah Salam; Pierre Delanaye; Richard Eastell; Arif Khwaja Journal: Clin J Am Soc Nephrol Date: 2016-02-15 Impact factor: 8.237
Authors: Elizabeth Shane; Adi Cohen; Emily M Stein; Donald J McMahon; Chiyuan Zhang; Polly Young; Kavita Pandit; Ronald B Staron; Elizabeth C Verna; Robert Brown; Susan Restaino; Donna Mancini Journal: J Clin Endocrinol Metab Date: 2012-09-28 Impact factor: 5.958
Authors: L E Nikkel; S Mohan; A Zhang; D J McMahon; S Boutroy; G Dube; B Tanriover; D Cohen; L Ratner; C S Hollenbeak; M B Leonard; E Shane; T L Nickolas Journal: Am J Transplant Date: 2011-12-07 Impact factor: 8.086
Authors: J-V Torregrosa; D Fuster; A Monegal; M A Gentil; J Bravo; L Guirado; A Muxí; J Cubero Journal: Osteoporos Int Date: 2010-03-13 Impact factor: 4.507