Administration of Denosumab Preserves Bone Mineral Density at the Knee in Persons With Subacute Spinal Cord Injury: Findings From a Randomized Clinical Trial

JBMR Plus, 2020 · DOI: 10.1002/jbm4.10375 · Published: August 1, 2020

Spinal Cord Injury Pharmacology Musculoskeletal Medicine

Simple Explanation

This study investigated the effect of denosumab on bone density in individuals with recent spinal cord injuries. Denosumab is a medication known to help maintain bone density. Participants with subacute motor-complete SCI were given either denosumab or a placebo over 18 months, and their bone density was measured. The primary focus was on bone density changes in the knee region. The results showed that denosumab helped to maintain bone density in the knee region, which is important because this area is prone to fractures in people with SCI.

Study Duration

18 months

Participants

26 SCI participants with subacute motor-complete SCI

Evidence Level

Level I, Randomized, double-blind, placebo controlled, parallel-group clinical trial

Key Findings

1
Denosumab maintained aBMD at the distal femur and proximal tibia in persons with a subacute motor-complete SCI.
2
Significant group × time interactions were observed for aBMD in the distal femoral metaphysis, distal femoral epiphysis, and proximal tibial epiphysis, favoring the denosumab group.
3
pQCT imaging revealed a continued trend toward signiﬁcantly greater loss in total volumetric BMD (vBMD) and trabecular vBMD at the 4% distal tibia region.

Research Summary

This study evaluated the effectiveness of denosumab in preserving bone mineral density (BMD) in individuals with subacute spinal cord injury (SCI). The findings indicate that denosumab maintained BMD at the knee region, the site of greatest clinical relevance in the SCI population. The study suggests that denosumab may offer a valuable prophylactic approach to prevent sublesional bone loss and fractures in individuals with chronic SCI.

Practical Implications

Clinical Practice

Denosumab administration provides a practical strategy for clinicians to maintain bone mass in persons with recent SCI.

Quality of Life

Improvements in sublesional bone BMD would be anticipated to improve conﬁdence to engage in personal activities and independence, thus, the ability to engage more conﬁdently in activities of daily living and to more fully integrate into the community.

Future Therapies

Improved bone health will also be a necessary clinical component of any future neuro-regenerative strategies that restore the ability to ambulate in persons with SCI.

Study Limitations

1
Limited sample size
2
Inability to find significant differences between the denosumab and placebo groups for the pQCT measurements was most likely because of the lack of sufficient statistical power caused by an insufficient size of the subgroups captured for imaging.
3
The size of the sample did not allow the determination of the effect of denosumab therapy for the demographic variables of age, gender, or race.

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