Long-term effect of denosumab on bone microarchitecture as assessed by tissue thickness–adjusted trabecular bone score in postmenopausal women with osteoporosis: results from FREEDOM and its open-label extension
Authors' conclusion
In postmenopausal women with osteoporosis, up to 10 years of denosumab significantly and continuously improved bone microarchitecture assessed by TBSTT, independently of BMD, and shifted more patients to lower fracture-risk categories.
Study context
- Population
- Postmenopausal women with lumbar spine (LS) or total hip BMD T-score <−2.5 and ≥−4.0 who completed the FREEDOM DXA substudy and continued in the open-label extension (OLE)
- Participants
- 150 vs 129
- Comparison
- Long-term denosumab vs crossover denosumab
- Long-term denosumabn = 150
- Crossover denosumabn = 129reference
- Primary endpoint
- Bone microarchitecture assessed by tissue thickness-adjusted trabecular bone score (TBSTT) on LS DXA scans
- Follow-up
- Up to year 10
Methodological detailsDXA substudy
- DXA substudy
Primary result
As reported in the abstract
Change from baseline in TBSTT, long-term denosumab · years 4, 5, 6, 8, and 10
Long-term denosumab
3.2%, 2.9%, 4.1%, 3.6%, and 4.7%
- Increases vs baseline at each time point
- all P < 0.0001
Further findings
- Change from baseline in LS BMD, long-term denosumab · years 4, 5, 6, 8, and 10
- 11.6%, 13.7%, 15.5%, 18.5%, and 22.4%
- Change from baseline in LS BMD, long-term denosumab — Increases vs baseline at each time point
- all P < 0.0001
Proportion at high / medium / low fracture risk (by TBSTT and BMD T-score), long-term denosumab, baseline to year 10
- High risk, baseline to year 10
- 93.7 to 40.4%
- Medium risk, baseline to year 10
- 6.3 to 53.9%
- Low risk, baseline to year 10
- 0 to 5.7%
- Shift across risk categories
- P < 0.0001
Correlation of changes in BMD and TBSTT
- Poorly correlated during denosumab treatment
Original publication
Long-term effect of denosumab on bone microarchitecture as assessed by tissue thickness–adjusted trabecular bone score in postmenopausal women with osteoporosis: results from FREEDOM and its open-label extension. Osteoporos Int. Published 2 March 2023. doi:10.
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