Attempted randomized controlled trial of pamidronate versus calcium and calcitriol supplements for management of steroid-induced osteoporosis in children and adolescents.
OBJECTIVE
To describe an attempted interventional trial for glucocorticoid-induced osteoporosis in children and adolescents and to discuss the reasons for trial failure to inform future interventional studies in this important group of patients.


METHODS
Prospective randomized controlled trial comparing the effect of bisphosphonate therapy with calcium and vitamin D supplementation on bone mineral accrual is described. For non-trial patients, retrospective analysis of the effect of calcium and vitamin D supplementation combined with bisphosphonate treatment on bone mineral accrual.


RESULTS
Only 12 patients were enrolled in the trial over 4 years. Bisphosphonate recipients (n = 5) had a mean annual percentage increase in lumbar spine bone mineral density of 8.76 +/- 5.2% compared to 6.6 +/- 4.0% in the calcium/vitamin-treated group (difference not significant). Mean annual change in lumbar spine areal bone mineral density in non-trial patients (n = 11) was 3.72 +/- 2.5%.


CONCLUSIONS
Conducting a randomized controlled trial in this group of corticosteroid users is difficult, given the unpredictable nature of the underlying disease and intermittent need for steroid treatment. The trial failed through inadequate recruitment combined with discontinued interventions.
Brown
J J
JJ
Department of Endocrinology and Diabetes, Royal Children's Hospital, Parkville, Victoria, Australia.
Zacharin
M R
MR
D000293:Adolescent; D000328:Adult; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D002117:Calcitriol / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D002118:Calcium / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D002648:Child; D019587:Dietary Supplements; D004164:Diphosphonates / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects*; D006801:Humans; D008297:Male; D010024:Osteoporosis / Q000139:chemically induced* / Q000188:drug therapy*; D000077268:Pamidronate; D014739:Victoria
D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D005938:Glucocorticoids; D002117:Calcitriol; D000077268:Pamidronate; D002118:Calcium