Trial reportThe lancet. Diabetes & endocrinology2026
3 months vs 12 months of romosozumab for postmenopausal osteoporosis (LIDA): an open-label, non-inferiority, randomised controlled trial.
Trial report in The lancet. Diabetes & endocrinology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05010590 (Anabolic Therapy in Postmenopausal Osteoporosis), which is not on this map. Cited by 7 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Anabolic Therapy in Postmenopausal Osteoporosis
Who cites it
7 citing papers in PubMed.
- Revisiting the activate depress free and repeat (ADFR) paradigm: Clinical use of cyclic romosozumab.Archives of osteoporosis · 2026Article
- Preventing Hip (Proximal Femoral) Fractures: An Evidence-Based Review for Clinicians.Journal of clinical medicine · 2026Review
- Three months of abaloparatide treatment rapidly improves bone formation and density: implications for orthopedic preoperative bone health optimization.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Article
- Romosozumab in severe postmenopausal osteoporosis-real-world data from 192 women.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Article
- Romosozumab super-responders in clinical practice: insights from a large Italian multicenter cohort of women with severe postmenopausal osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Article
- Case Report: Reopening the anabolic window - romosozumab added to ongoing denosumab for severe osteoporosis in two kidney transplant recipients.Frontiers in endocrinology · 2026Article
- G protein-coupled receptor signaling in osteogenic bone mesenchymal stem/stromal cells.Frontiers in cell and developmental biology · 2026Review
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
backgroundPostmenopausal osteoporosis is a highly prevalent disease associated with substantial morbidity and mortality. The most recently introduced osteoporosis medication is romosozumab, a monoclonal antibody with a unique mechanism of action that increases bone mineral density (BMD) more than other agents by both stimulating new bone formation and inhibiting resorption. The drug's stimulation of bone formation, however, wanes after several months. The use of romosozumab is limited by cost, the inconvenience of monthly clinic-administered injections, and its cardiovascular risk profile. In this trial, we aimed to test the hypothesis that a shorter course of romosozumab might be equally effective as the standard regimen.
methodsWe did a 12-month, prospective, open-label, randomised, controlled, non-inferiority trial of 50 postmenopausal women at high risk of fracture. The study was done at a single academic medical centre in the USA. Participants were randomly assigned to receive 3 months of romosozumab (210 mg by subcutaneous injection, monthly) followed by 9 months of denosumab (60 mg by subcutaneous injection, every 6 months; 3-month ROMO group) or 12 months of romosozumab (12-month ROMO group). The primary endpoint was the percentage change in total hip BMD. The non-inferiority threshold was set at 2%. The trial was registered at ClinicalTrials.gov, NCT05010590.
findingsBetween March 2, 2022, and May 2, 2023, we screened 188 participants. Of those, 102 (54%) were ineligible and 36 (19%) declined to participate. We randomly assigned 50 participants to either the 3-month ROMO group (24 [48%] participants) or the 12-month ROMO group (26 [52%] participants). Study participants completing at least one post-baseline visit were included in the analysis (modified intention-to-treat analysis). The mean age of participants was 69·6 years (SD 4·5). The mean 12-month change in total hip BMD was 5·7% (SD 3·3) in the 3-month romosozumab group and 6·0% (3·2) in the 12-month romosozumab group, meeting the prespecified non-inferiority threshold. Adverse events (back pain, cough, fatigue, headache, joint pain, muscle cramps, muscle pain, palpitations, paraesthesia, reaction at injection site, rhinorrhoea, skin rash, and swelling) were balanced between groups.
interpretationIn 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.
fundingUS National Institute of Arthritis and Musculoskeletal and Skin Diseases and US National Center for Advancing Translational Science.
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