Loss of lower extremity bone mineral density 1 year after denosumab is discontinued in persons with subacute spinal cord injury
Authors' conclusion
In persons with SCI who initiated denosumab treatment during the subacute injury phase and maintained treatment for 1 year, the discontinuation of drug resulted in percent loss of mean BMD similar to that of the placebo group, with absolute mean BMD values at the knee regions at the 12-month follow-up visit significantly higher in the drug treatment than those in the placebo group. These data underscore the need to study continued administration of denosumab after subacute SCI to avoid marked demineralization in the sublesional skeleton upon discontinuation of this agent.
Study context
- Population
- Persons with subacute spinal cord injury (SCI) who started drug within 90 days post SCI and continued for 1 yearcompleted parent trial
- Participants
- 14 persons
- Comparison
- Denosumab vs placebo, 12 months after discontinuation
- Denosumabn = 8
- Placebon = 6reference
Methodological detailsdouble-blinded, placebo-controlled
- Double-blinded
- Placebo-controlled
Primary result
As reported in the abstract
- Percent decreases in mean bone mineral density (BMD) at all hip and knee regions similar in denosumab and placebo
Further findings
| Outcome | P value |
|---|---|
| Absolute mean BMD · 30 monthsDenosumab vs Placebo · DFM; higher with denosumab | P = 0.03 |
| Absolute mean BMD · 30 monthsDenosumab vs Placebo · DFE; higher with denosumab | P = 0.04 |
| Absolute mean BMD · 30 monthsDenosumab vs Placebo · PTE; higher with denosumab | P = 0.05 |
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
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