PMID- 12730532
OWN - NLM
STAT- MEDLINE
DCOM- 20030718
LR  - 20181130
IS  - 1462-0324 (Print)
IS  - 1462-0324 (Linking)
VI  - 42
IP  - 6
DP  - 2003 Jun
TI  - Three-monthly ibandronate bolus injection offers favourable tolerability and 
      sustained efficacy advantage over two years in established corticosteroid-induced 
      osteoporosis.
PG  - 743-9
AB  - 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. METHOD: 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.
FAU - Ringe, J D
AU  - Ringe JD
AD  - Medizinische Klinik IV, Klinikum Leverkusen, University of Cologne, Leverkusen, 
      Germany. ringe@klinikum-lev.de
FAU - Dorst, A
AU  - Dorst A
FAU - Faber, H
AU  - Faber H
FAU - Ibach, K
AU  - Ibach K
FAU - Preuss, J
AU  - Preuss J
LA  - eng
PT  - Clinical Trial
PT  - Controlled Clinical Trial
PT  - Journal Article
DEP - 20030416
PL  - England
TA  - Rheumatology (Oxford)
JT  - Rheumatology (Oxford, England)
JID - 100883501
RN  - 0 (Diphosphonates)
RN  - 0 (Glucocorticoids)
RN  - 0 (Hydroxycholecalciferols)
RN  - UMD7G2653W (Ibandronic Acid)
RN  - URQ2517572 (alfacalcidol)
SB  - IM
MH  - Aged
MH  - Back Pain/drug therapy
MH  - Bone Density/drug effects
MH  - Calcaneus/physiopathology
MH  - Diphosphonates/*administration & dosage/therapeutic use
MH  - Drug Administration Schedule
MH  - Female
MH  - Femur Neck/physiopathology
MH  - Glucocorticoids/*adverse effects
MH  - Humans
MH  - Hydroxycholecalciferols/therapeutic use
MH  - Ibandronic Acid
MH  - Injections, Intravenous
MH  - Lumbar Vertebrae/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Osteoporosis/chemically induced/*drug therapy/physiopathology
MH  - Prospective Studies
MH  - Spinal Fractures/prevention & control
EDAT- 2003/05/06 05:00
MHDA- 2003/07/19 05:00
CRDT- 2003/05/06 05:00
PHST- 2003/05/06 05:00 [pubmed]
PHST- 2003/07/19 05:00 [medline]
PHST- 2003/05/06 05:00 [entrez]
AID - keg205 [pii]
AID - 10.1093/rheumatology/keg205 [doi]
PST - ppublish
SO  - Rheumatology (Oxford). 2003 Jun;42(6):743-9. doi: 10.1093/rheumatology/keg205. 
      Epub 2003 Apr 16.