3 months vs 12 months of romosozumab for postmenopausal osteoporosis (LIDA): an open-label, non-inferiority, randomised controlled trial
Authors' conclusion
In postmenopausal women at high risk of fracture, 3 months of romosozumab followed by 9 months of denosumab was non-inferior to 12 months of romosozumab in increasing total hip BMD. Given the expense, injection burden, and potential adverse effects of romosozumab, this abbreviated approach could broaden access to this uniquely effective therapy.
Study context
- Population
- Postmenopausal women at high risk of fracture, single academic medical centre in the USA; mean age 69.6 years (SD 4.5)modified ITT analysis
- Participants
- 50 women
- Comparison
- 3 months of romosozumab followed by 9 months of denosumab vs 12 months of romosozumab
- 3-month ROMOn = 24
- 12-month ROMOn = 26reference
- Primary endpoint
- Percentage change in total hip bone mineral density (BMD)
- Follow-up
- 12 months
Methodological detailsopen-label, non-inferiority, prospective, single-centre, Screened 188; 102 (54%) ineligible, 36 (19%) declined; enrolled March 2, 2022 to May 2, 2023
- Open-label
- Non-inferiority
- Prospective
- Single-centre
- Screened 188; 102 (54%) ineligible, 36 (19%) declined; enrolled March 2, 2022 to May 2, 2023
Primary result
As reported in the abstract
Change in total hip BMD
3-month ROMO
5.7
mean · SD 3.3 · %
12-month ROMO
6.0
mean · SD 3.2 · %
Safety
- Adverse events (back pain, cough, fatigue, headache, joint pain, muscle cramps, muscle pain, palpitations, paraesthesia, injection-site reaction, rhinorrhoea, skin rash, swelling) were balanced between groups
Original publication
3 months vs 12 months of romosozumab for postmenopausal osteoporosis (LIDA): an open-label, non-inferiority, randomised controlled trial. Lancet Diabetes Endocrinol. Published 29 January 2026. doi:10.
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