Three-monthly ibandronate bolus injection offers favourable tolerability and sustained efficacy advantage over two years in established corticosteroid-induced osteoporosis.
OBJECTIVE
Corticosteroids are widely prescribed, although treatment-related side-effects are common. Of these adverse events (AEs), osteoporosis is considered the most serious. Currently, oral bisphosphonates are the standard treatment for corticosteroid-induced osteoporosis (CIO). However, intermittent intravenous (i.v.) therapy may have advantages, including lack of gastrointestinal AEs, improved bioavailability and increased compliance. This study investigated the efficacy and safety of 3-monthly i.v. ibandronate bolus injections in patients with established CIO. The results from a planned 2-yr interim analysis are reported.


METHODS
In this controlled, prospective, open-label, parallel-group study, 104 patients (49 men and 55 women) with established CIO (mean T-score <-2.5 s.d. at the lumbar spine (L2-L4) received daily calcium (500 mg) plus either 3-monthly i.v. ibandronate (2 mg) bolus injections or oral daily alfacalcidol (1 micro g). The primary end-point was bone mineral density (BMD) change at the lumbar spine, femoral neck and calcaneus after 24 months.


RESULTS
Compared with oral daily alfacalcidol, i.v. ibandronate produced significantly superior gains in mean (+/-s.d.) BMD at the lumbar spine (2.2+/-3.1 vs 11.9+/-7.4%; P<0.001), femoral neck (1.3+/-1.8 vs 4.7+/-4.0%; P<0.001) and calcaneus (7.6+/-3.8 vs 15.5+/-10.7%; P<0.0001) after 2 yr. Consistent with these BMD gains and, although the study was not powered for fractures, a trend towards a reduction in vertebral fractures and greater back pain relief was seen in the ibandronate group. The overall incidence of AEs was similar in the two treatment arms.


CONCLUSIONS
Three-monthly i.v. ibandronate bolus injections are significantly superior to alfacalcidol in the treatment of CIO. These data confirm the potential of ibandronate for the treatment of osteoporosis associated with corticosteroid use. The ease of administration, lack of AEs and good compliance associated with intermittent i.v. ibandronate make it a potentially valuable alternative to oral bisphosphonate therapy for the treatment of CIO.
Medizinische Klinik IV, Klinikum Leverkusen, University of Cologne, Leverkusen, Germany. ringe@klinikum-lev.de
J D
JD
Ringe
A
A
Dorst
H
H
Faber
K
K
Ibach
J
J
Preuss
D000368:Aged; D001416:Back Pain / Q000188:drug therapy; D015519:Bone Density / Q000187:drug effects; D002111:Calcaneus / Q000503:physiopathology; D004164:Diphosphonates / Q000008:administration & dosage* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D005272:Femur Neck / Q000503:physiopathology; D005938:Glucocorticoids / Q000009:adverse effects*; D006801:Humans; D006887:Hydroxycholecalciferols / Q000627:therapeutic use; D000077557:Ibandronic Acid; D007275:Injections, Intravenous; D008159:Lumbar Vertebrae / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced / Q000188:drug therapy* / Q000503:physiopathology; D011446:Prospective Studies; D016103:Spinal Fractures / Q000517:prevention & control
D004164:Diphosphonates; D005938:Glucocorticoids; D006887:Hydroxycholecalciferols; D000077557:Ibandronic Acid; C008088:alfacalcidol