Efficacy and Safety of Transdermal Abaloparatide in Postmenopausal Women with Osteoporosis: A Randomized Study
Primary result · Percentage change in lumbar spine BMDResult — go to the resultTreatment difference −3.72 % 95% CI −5.01% to −2.43%Authors' conclusion
Noninferiority of abaloparatide-sMTS to abaloparatide-SC for percentage change in spine BMD at 12 months was not demonstrated; however, clinically meaningful increases from baseline in lumbar spine and total hip BMD were observed in both treatment groups.
Study context
- Population
- Postmenopausal women with osteoporosisrandomized 1:1
- Participants
- 511 women
- Comparison
- Abaloparatide via microstructured transdermal system vs subcutaneously (SC) injection
- Primary endpoint
- Percentage change in lumbar spine bone mineral density (BMD) (noninferiority margin 2.0%)
- Follow-up
- 12 months
Methodological detailsphase 3, noninferiority, open-label
- Phase 3
- Noninferiority
- Open-label
Primary result
Percentage change in lumbar spine BMD
Treatment difference
−3.72 %
95% CI −5.01% to −2.43%
Change by group
abaloparatide-sMTS
7.14
SE 0.46% · %
abaloparatide-SC
10.86
SE 0.48% · %
abaloparatide-sMTSvs abaloparatide-SC
treatment difference −3.72 % (95% CI −5.01% to −2.43%)
As reported in the abstract
Secondary outcomes
| Outcome | abaloparatide-sMTS | abaloparatide-SC |
|---|---|---|
| Percentage change in total hip BMD | 1.97 % | 3.70 % |
| Change from baseline in serum P1NP · 12 monthsMedian, % | 52.6 | 74.5 |
New clinical fractures
- Few new clinical fractures occurred in either group
Safety
Administration site reactions (most frequent adverse events)
Serious adverse events and skin reactions
- Incidence of serious adverse events was similar between groups
- Mild or moderate skin reactions with abaloparatide-sMTS; no identifiable risk factors for sensitization reactions
Original publication
Efficacy and Safety of Transdermal Abaloparatide in Postmenopausal Women with Osteoporosis: A Randomized Study. J Bone Miner Res. Published 27 July 2023. doi:10.
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