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Randomized Trial of Effect of Cyclical Etidronate in the Prevention of Corticosteroid-Induced Bone Loss

Centre d’Evaluation des Maladies Osseuses (C.R.), Hôpital Cochin, 75014 Paris; Clinique de Rhumatologie (B.C.), Hôpital B, 59037 Lille Cedex; Service d’Endocrinologie (J.M.P.), Hôpital Rangueil, 31054 Toulouse Cedex; Procter & Gamble Pharmaceuticals France (S.H.), 92201 Neuilly sur Seine Cedex, France; Istituto di Patologia Medica (O.D.M.), Università di Pisa, 56126 Pisa; Servizio di Rheumatologia (P.O.), Nuovo Policlinico, 80131 Napoli, Italy; Department of Rheumatology (R.A.H.), St. Peter Hospital, Guilford Hospital, Surrey KT 16 OPZ, United Kingdom; Department of Endocrinology and Rheumatology (S.G.), Unit of Osteoporosis and Metabolic Bone Diseases, Universiteits Ziekenhuis Gent, B-9000 Gent, Belgium; Department of Rheumatology (R.L.), Adademish Ziekenhuis St. Radboud, 6500 HB Nijmegen, The Netherlands; (J.I.) 86150 Augsburg, Germany

Address correspondence and requests for reprints to: Dr. Christian Roux, Centre d’Evaluation des Maladies Osseuses, Hôpital Cochin, 27 rue du Faubourg Saint Jacques, 75014 Paris, France.

Abstract

Osteoporosis is a well-recognized adverse effect of corticosteroid therapy. This study aimed to investigate the effect of etidronate, intermittent cyclical therapy, in the prevention of corticosteroid-induced bone loss.

Patients with various medical conditions starting high-dose corticosteroid therapy were enrolled in the study. The treatment had to be expected to continue for at least 12 months with the initial 90 days at a mean daily dose of at least 7.5 mg of prednisone, with subsequent treatment of at least 2.5 mg/day. One hundred seventeen patients were randomly assigned oral etidronate 400 mg/day, or placebo, for 14 days, followed by 76 days of oral calcium carbonate (500 mg elemental calcium), cycled over 12 months. The primary outcome measure was the difference in percent change from baseline in bone mineral density of the lumbar spine between the groups at the end of year 1. Secondary measures included changes in femur bone density and in biochemical markers of bone remodeling.

The mean (±SEM) lumbar spine bone density changed 0.30 ± 0.61% and -2.79 ± 0.63% in the etidronate and placebo groups, respectively. The mean difference between groups after 1 yr was 3.0 ± 0.84% (P = 0.004). The changes in the femoral neck and great trochanter were not different between the groups. There was a decrease in pyridinium crosslinks, significant from baseline at both 6 and 12 months, in the etidronate group. Osteocalcin increased in the placebo group, and difference between groups was -25.07 ± 14.89% (P = 0.032) and -34.68 ± 19.77% (P = 0.051), at 6 and 12 months respectively. There was no significant difference between the groups in number of adverse experiences, including gastrointestinal disorders.

Etidronate intermittent cyclical therapy prevents lumbar vertebral bone loss in patients starting high-dose corticosteroid therapy.

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