Efficacy and Safety of Denosumab vs Zoledronic Acid in Osteogenesis Imperfecta (OI) Adults: A Prospective, Open-Label, Randomized Study
Authors' conclusion
Denosumab effectively increases aBMD in adults with OI, with similar efficacy to zoledronic acid. Long-term and large-sample studies are needed to confirm the antifracture efficacy and safety of denosumab in adult patients with OI.
Study context
- Population
- Adults with osteogenesis imperfecta (OI); 49 with identified pathogenic mutations
- Participants
- 51 adults
- Comparison
- Denosumab vs zoledronic acid
- Denosumabn = 25
- Zoledronic acidn = 26reference
- Primary endpoint
- Percentage changes in aBMD, TBS and BTMs from baseline
- Follow-up
- 6 and 12 months
Methodological detailsprospective, open-label
- Prospective
- Open-label
Primary result
As reported in the abstract
Percentage change in aBMD · 12 months
| Group | Lumbar spine areal bone mineral density (aBMD) change | Total hip aBMD change |
|---|---|---|
| Denosumab | 4.34% (P = .005) | 1.45% (P = .023) |
| Zoledronic acid | 4.92% (P = .006) | 2.02% (P = .016) |
Lumbar spine areal bone mineral density (aBMD) change
Denosumab4.34% (P = .005)
Zoledronic acid4.92% (P = .006)
Total hip aBMD change
Denosumab1.45% (P = .023)
Zoledronic acid2.02% (P = .016)
Further findings
| Outcome | Denosumab | Zoledronic acid |
|---|---|---|
| Percentage change in TBS (increasing trend) | 1.39% | 2.70% |
- Trabecular bone score (TBS) change with denosumab by OI phenotype · 12 months · Milder phenotypes vs More severe phenotypes · significantly higher TBS increase with milder phenotypes
- P = 0.030
BTMs after denosumab
- Serum β-CTX and alkaline phosphatase markedly decreased after denosumab
Safety
Adverse events · study period
- Denosumab had fewer adverse events than zoledronic acid
Original publication
Efficacy and Safety of Denosumab vs Zoledronic Acid in OI Adults: A Prospective, Open-Label, Randomized Study. J Clin Endocrinol Metab. Published 5 January 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →