Romosozumab improves microarchitecture as assessed by tissue thickness–adjusted trabecular bone score in postmenopausal women with osteoporosis
Primary result · Gain in TBSTTResult — go to the resultLeast squares mean difference 3.6 %Authors' conclusion
In postmenopausal women with osteoporosis and prior fracture, 12-mo romosozumab followed by 24-mo alendronate significantly improved bone microarchitecture estimated by TBSTT more than 36-mo alendronate alone.
Study context
- Population
- Postmenopausal women with osteoporosis and prior fracture from ARCH with post-hoc Trabecular Bone Score (TBS) measurements at baseline and ≥1 post-baseline visit (months 12, 24, 36)
- Participants
- 190 vs 188
- Comparison
- Romosozumab-to-alendronate vs alendronate alone
- Romosozumab-to-alendronaten = 190
- Alendronate alonen = 188reference
- Primary endpoint
- Tissue thickness-adjusted TBS (TBSTT)
- Follow-up
- Months 12, 24 and 36
Methodological detailsactive-controlled, open-label alendronate phase
- Active-controlled
- Open-label alendronate phase
Primary result
Gain in TBSTT · month 12
Least squares mean difference
3.6 %
P < 0.001
As reported in the abstract
Further findings
| Outcome | Least squares mean difference (%) | P value |
|---|---|---|
| Gain in TBSTT · month 24Greater gains with romosozumab-to-alendronate | 2.9 | P < 0.001 |
| Gain in TBSTT · month 36Greater gains with romosozumab-to-alendronate | 2.3 | P < 0.001 |
Patients with normal TBSTT, romosozumab-to-alendronate · baseline; months 12, 24, 36
- Baseline
- 28.9%
- Month 12
- 48.1%
- Month 24
- 43.9%
- Month 36
- 45.4%
- All p<.001
Patients with degraded TBSTT, romosozumab-to-alendronate · baseline; months 12, 24, 36
- Baseline
- 52.6%
- Month 12
- 33.3%
- Month 24
- 36.0%
- Month 36
- 33.5%
- All p<.001
Normal/degraded TBSTT, alendronate alone · baseline through month 36
- Similar but smaller trend
- P ≤ 0.012
Correlation of changes in TBSTT and lumbar spine (LS) bone mineral density (BMD) · baseline to month 12 and month 36
- Romosozumab-to-alendronate, month 12, r2
- 0.065
- Alendronate alone, month 12, r2
- 0.021
- Romosozumab-to-alendronate, month 36, r2
- 0.058
- Alendronate alone, month 36, r2
- 0.057
- Largely unrelated
Original publication
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