Session Type: Abstract Submissions (ACR)
Background/Purpose: To assess the efficacy of strontium ranelate 2g/day in the improvement of healing of peripheral fractures with delayed union or aseptic non-union.
Methods: International, phase III, open label study with a treatment duration of 6 months. Primary endpoint was the radiological status of the fracture (progress to union, union, failure to union) at 6 months (central X-ray reading), among assessable patients according to intent-to-treat principle. Other efficacy criteria included pain assessment using a Visual Analog Scale (VAS), Lower limb questionnaire, QuickDASH questionnaire (upper limb and clavicle) and quality of life (EQ-5D questionnaire).
Results: 48 patients were included (28 men and 20 women) and 44 completed the study. 4 patients withdrew the study, 3 due to non-medical reasons and 1 due to protocol deviation. Mean age at inclusion was 49.4±18.5 years. 53.7% were osteoporotic. The qualifying fracture was localised for 34 patients in the lower limb, and for 14 patients in the upper limb/clavicle. The status of the fracture at baseline was non-union* in 60.4% and delayed union** in 39.6%. The mean duration of the qualifying fracture was 22.8+27.5 months.
40 patients were included in the intend-to-treat (ITT) population. In this population, 72.5% of the fractures had improved, with 32.5% of progress to union and 40% of union over 6 months. 18 of the 26 fractures reported as non-union fractures at baseline and 11 of the 14 fractures assessed as delayed union fractures at baseline improved to union or progress to union over 6 months.
48.7% of the patients reported a decrease of more than 50% of their pain, with a mean change in the VAS from baseline (36.9 ± 24.7 mm) to last post-baseline value over M0-M6 of -18.6 ± 3.6 mm (p≤ 0.0001).
There was also a positive trend in the changes in the algo-functional behaviour of the affected limb and in the patient’s global quality of life as assessed with the EQ-5D questionnaire. No unexpected adverse events were reported.
Conclusion: This open label study suggests that a 6-month treatment with strontium ranelate (2g/day) improves healing of aseptic delayed or non-united fractures of the limbs or of the clavicle.
*Non-union defined as non-union for at least 6 months and no sign of radiological healing or bone reaction since at least 3 months.
**Delayed union defined as an absence of radiological full union after 6 months according to investigator’s opinion.
J. M. Feron,
L. A. T. Russo,
J. D. Laredo,
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-of-a-6-month-treatment-with-strontium-ranelate-2gday-in-the-improvement-of-long-bone-fractures-with-delayed-union-or-non-union/