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.
RCT Entities:
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.
Authors: A Balasubramanian; S W Wade; R A Adler; C J F Lin; M Maricic; C D O'Malley; K Saag; J R Curtis Journal: Osteoporos Int Date: 2016-06-08 Impact factor: 4.507
Authors: Bernhard Rintelen; Klaus Bobacz; Günter Höfle; Peter Peichl; Franz Rainer; Kurt Weber; Markus Gaugg Journal: Wien Klin Wochenschr Date: 2011-08-25 Impact factor: 1.704
Authors: S Lekamwasam; J D Adachi; D Agnusdei; J Bilezikian; S Boonen; F Borgström; C Cooper; A Diez Perez; R Eastell; L C Hofbauer; J A Kanis; B L Langdahl; O Lesnyak; R Lorenc; E McCloskey; O D Messina; N Napoli; B Obermayer-Pietsch; S H Ralston; P N Sambrook; S Silverman; M Sosa; J Stepan; G Suppan; D A Wahl; J E Compston Journal: Osteoporos Int Date: 2012-03-21 Impact factor: 4.507