High incidence rate of vertebral fractures during chronic prednisone treatment, in spite of bisphosphonate or alfacalcidol use. Extension of the alendronate or alfacalcidol in glucocorticoid-induced osteoporosis-trial.
OBJECTIVE
In the 18 month "alendronate or alfacalcidol in glucocorticoid-induced osteoporosis"-trial (STOP-trial) patients with rheumatic diseases who started glucocorticoids were randomised to anti-osteoporosis therapy with either daily alendronate (10 mg) or alfacalcidol (1 microg). In the present observational open follow-up study of the STOP-trial, we report the long-term effects of risk factors on the incidence and pattern of vertebral fractures, assessed using the Genant method.


RESULTS
Of the 201 included patients in the STOP-trial, 163 completed the trial and of those 116 underwent a follow-up radiography of the spine. Twenty-eight patients had developed one or more new vertebral fractures since the end of the STOP-trial. The majority of fractures was wedge shaped and the deformities were intermediate to severe in both the former alendronate and alfacalcidol group. Multiple logistic regression analysis showed that STOP-trial medication and presence of pre-existing fractures did not predict development of new fractures, whereas age and cumulative glucocorticoid-dose did.


CONCLUSIONS
During the follow-up 2.7 years after the STOP-trial both in the former alendronate and alfacalcidol group 24% of the patients underwent at least one new vertebral fracture. This underlines that prevention of vertebral fractures remains a clinical challenge, even when anti-osteoporosis drugs are prescribed.
Hoes
Jos N
JN
Department of Rheumatology and Clinical Immunology, University Medical Center, Utrecht, The Netherlands. mail@HoesJN.org
Jacobs
Johannes W G
JW
Hulsmans
Harry M J
HM
De Nijs
Ron N J
RN
Lems
Willem F
WF
Bruyn
George A W
GA
Geusens
Piet P M M
PP
Bijlsma
Johannes W J
JW
D000368:Aged; D019386:Alendronate / Q000008:administration & dosage*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage; D004347:Drug Interactions; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D006887:Hydroxycholecalciferols / Q000008:administration & dosage*; D015994:Incidence; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced* / Q000453:epidemiology; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects*; D012216:Rheumatic Diseases / Q000188:drug therapy*; D012307:Risk Factors; D016103:Spinal Fractures / Q000139:chemically induced* / Q000453:epidemiology / Q000517:prevention & control; D017211:Treatment Failure
D050071:Bone Density Conservation Agents; D005938:Glucocorticoids; D006887:Hydroxycholecalciferols; C008088:alfacalcidol; D011241:Prednisone; D019386:Alendronate