Research Summary

Abbreviated Romosozumab Therapy Achieves Comparable Hip BMD Increases in Postmenopausal Women

Anthony Calabro, MA

Key Highlights

  • A 3-month romosozumab regimen followed by denosumab was non-inferior to 12 months of romosozumab for total hip bone mineral density (BMD) gains.
  • BMD increased by 5.7% with the abbreviated regimen and 6% with standard therapy.
  • Bone density changes at the femoral neck, lumbar spine, and distal radius were similar between groups.
  • Adverse events were balanced, with no reported myocardial infarction or stroke in either group.

Postmenopausal women at high risk of fracture achieved comparable gains in total hip bone mineral density (BMD) with a shortened romosozumab regimen followed by denosumab compared with the standard 12-month romosozumab course, according to findings published in The Lancet Diabetes & Endocrinology. The open-label, randomized non-inferiority trial was conducted at a single academic medical center in the United States.

Researchers designed the LIDA trial to test whether a shorter duration of the osteoporosis medication, romosozumab, could preserve efficacy while potentially reducing treatment burden, cost, and exposure to adverse effects. Fifty postmenopausal women aged 45 years or older with osteoporosis or prior fragility fracture were enrolled and followed for 12 months.

Participants were randomly assigned to receive a subcutaneous injection of either 3 months of romosozumab (210 mg monthly) followed by 9 months of denosumab (60 mg by subcutaneous injection, every 6 months; 3-month romosozumab group) or 12 months of romosozumab alone (12-month romosozumab group). The primary endpoint was percentage change in total hip BMD at 12 months, with a prespecified non-inferiority margin of 2%.

Study Findings

At 12 months, mean total hip BMD increased by 5.7% (SD 3.3) in the 3-month romosozumab group and by 6% (SD 3.2) in the 12-month group. The between-group difference met the non-inferiority criterion.

Secondary endpoints showed similar patterns. Femoral neck BMD increased by 5% in the abbreviated group and 6.3% in the standard group, while lumbar spine BMD increased by 10.6% and 12.5%, respectively. Changes in distal radius BMD were minor and did not significantly differ between groups. Serum markers of bone turnover reflected early increases in bone formation followed by sustained suppression of resorption in participants receiving denosumab.

Adverse events, including musculoskeletal symptoms and injection-site reactions, were common but generally mild and balanced between groups. Serious adverse events occurred only in the 12-month romosozumab group and were deemed unrelated to treatment. No participant experienced myocardial infarction, stroke, or death during the study.

Clinical Implications

According to the study authors, the findings suggest that a shorter romosozumab course followed by denosumab can achieve similar skeletal benefits to prolonged romosozumab exposure in postmenopausal women at high fracture risk. They noted that this approach may help address practical limitations associated with romosozumab, including cost, the need for monthly clinic visits, and safety concerns.

Expert Commentary

“Three months of romosozumab followed by 9 months of denosumab was non-inferior to 12 months of romosozumab in increasing total hip BMD,” the researchers concluded. “The ability of both regimens to increase BMD at the femoral neck, lumbar spine, and distal radius was also similar.”

Reference:
Leder BZ, Ramchand SK, Jordan M, et al. Three months vs 12 months of romosozumab for postmenopausal osteoporosis (LIDA): an open-label, non-inferiority, randomized controlled trial. Lancet Diabetes Endocrinol. Published online January 29, 2026. doi:10.1016/S2213-8587(26)000XX-X