Preventive treatment with alendronate of loss of bone mineral density in acute traumatic spinal cord injury. Randomized controlled clinical trial.

STUDY

DESIGN

Randomized controlled clinical trial of two parallel groups.

OBJECTIVES

Analyse the efficacy of primary prevention with alendronate on the loss of bone mass which occurs during the first year of traumatic SCI, measured by double-energy X-ray bone densitometry (DXA).

SETTING

National Hospital for Paraplegics (HNP), Toledo, Spain.

METHODS

We included 52 people admitted to the HNP with traumatic SCI Grade A and B on the ASIA Impairment Scale and less than 8 weeks of progression, which were randomized to one of the two treatment groups. Both groups received calcifediol and a calcium-enriched diet for 52 weeks. Only one group was administered alendronate 70 mg weekly. The dose of alendronate was adjusted according to changes in serum β-CTX.

RESULTS

52 Participants were randomized. Of the 26 assigned to each group, 4 patients were lost in the alendronate group and 3 in the control group. The random distribution of women was asymmetrical, so we analysed the effect of treatment on men. In the total left hip, the mean (SD) decrease in bone mass was -22.791% (10.768) in the control group compared to the mean (SD) decrease of -2.693% (6.283) in the same location in the alendronate group (p < 0.0001). No patient presented related adverse events.

CONCLUSION

Alendronate administered for one year in the first 8 weeks after traumatic SCI decreases bone loss in the hip in men. This treatment is well tolerated.