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

Objectives: 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.