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. 2015 Apr 17;50(3):274-82.
doi: 10.1016/j.rboe.2015.04.004. eCollection 2015 May-Jun.

Use of risedronate for consolidation and callus formation in Colles fractures in postmenopausal women: SOLID study

Lindomar Guimarães Oliveira  1 , Sérgio Ragi Eis  2 , Henrique Mota Neto  3 , Frederico Barra de Moraes  4 , Luiz Antônio Silveira Simões Pires  5 , José Wanderley Vasconcelos  6
Affiliations

Use of risedronate for consolidation and callus formation in Colles fractures in postmenopausal women: SOLID study

Lindomar Guimarães Oliveira et al. Rev Bras Ortop. .

Abstract
in English, Portuguese

Objective: This open, randomized and blinded parallel-group multicenter study evaluated the efficacy of Actonel(®) (35 mg) plus calcium/vitamin D versus calcium/vitamin D alone for preserving bone mineral density (BMD) in postmenopausal women with Colles fractures.

Methods: Patients with a Colles fracture for seven days were randomized to receive either Actonel(®) (35 mg) once a week plus calcium/vitamin D (ACD group) or calcium/vitamin D alone (CD group). The patients were evaluated after 90 and 180 days of treatment.

Results: 59 ACD patients and 56 CD patients completed all the evaluations. At the end of the study, the BMD of the radius at the fracture location showed a negative change in the CD group (32.8%). The loss of BMD in the ACD group (20.8%) was slightly less than that in the CD group. There was a difference in the proportions of patients with BMD losses at the end of the study period in the two treatment groups, in favor of the ACD group, although this was not statistically significant. There was no significant difference in radiological identification of callus formation between the treatment groups. In the majority of the patients, the callus could be radiologically identified after 90 days.

Conclusion: Postmenopausal women with Colles fractures who received risedronate sodium plus calcium/vitamin D did not show any significant difference in BMD loss in forearm fractures, in comparison with those who received calcium/vitamin D alone. Risedronate presented a tendency toward a protective effect regarding BMD loss due to immobilization. The time taken for fracture consolidation to be achieved was unaffected.

Objetivo: Este estudo multicêntrico, randomizado, aberto, grupo paralelo avaliou a eficácia de Actonel® 35 mg mais cálcio/vitamina D versus cálcio/vitamina D isoladamente na preservação da densidade mineral óssea (DMO) em mulheres pós-menopausadas com fratura de Colles.

Métodos: Pacientes com fratura de Colles em sete dias foram aleatoriamente designadas para receber Actonel® 35 mg semanalmente mais cálcio/vitamina D (Grupo AO [GAO]) ou cálcio/vitamina D (grupo O [GO]) isoladamente. As pacientes foram avaliadas após 90 e 180 dias de tratamento.

Resultados: Completaram as avaliações 59 pacientes no GAO e 56 no OG. No fim do estudo, a DMO do rádio no local da fratura mostrou variação negativa no GO (32,8%) que foi discretamente menor no GAO (20,8%), assim como uma perda menor na DMO no GAO comparado com o OG. Houve diferença na proporção de paciente com perda da DMO no fim do estudo nos dois grupos de tratamento em favor do GAO, apesar de não estatisticamente significante. Não houve diferença significativa na identificação radiológica da formação do calo entre os grupos de tratamento. Na maioria das pacientes a identificação radiológica do calo ocorreu depois de 90 dias.

Conclusão: Mulheres pós-menopausadas com fratura de Colles que receberam risedronato sódico, além do cálcio/vitamina D, comparado com cálcio/vitamina D não mostraram diferença significativa na perda da DMO na fratura do antebraço, com tendência de efeito protetor do risedronato na perda da DMO devido à imobilização. O tempo até a consolidação da fratura não foi afetado.

Keywords: Bisphosphonates; Colles fracture; Fracture consolidation.

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Figures

Fig. 1
Fig. 1
Distribution of the patients.
Fig. 2
Fig. 2
Results from the ANOVA model for the fractured side.
Fig. 3
Fig. 3
Results from the ANOVA model for the non-fractured side.
See this image and copyright information in PMC

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