Trial reportThe Journal of bone and joint surgery. American volume2020
A Randomized, Placebo-Controlled Study of Romosozumab for the Treatment of Hip Fractures.
Trial report in The Journal of bone and joint surgery. American volume, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01081678 (A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy, Safety, and Tolerability of AMG 785 in Adults With a Fresh Unilateral Hip Fracture, Status Post Surgical Fixation), which is not on this map. Cited by 56 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy, Safety, and Tolerability of AMG 785 in Adults With a Fresh Unilateral Hip Fracture, Status Post Surgical Fixation
Who cites it
56 citing papers in PubMed, 3 syntheses or guidelines pooled it, 83 citations in OpenAlex.
- Assessment of the efficacy and safety of anti-sclerostin antibody therapy for osteoporosis in postmenopausal women: a systematic review and meta-analysis of randomized controlled trials.Frontiers in endocrinology · 2025Pooled it
- Executive summary: Italian guidelines for diagnosis, risk stratification, and care continuity of fragility fractures 2021.Frontiers in endocrinology · 2023Pooled it
- A systematic review and meta-analysis of efficacy and safety of Romosozumab in 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 · 2022Pooled it
- Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2024Trial
- Fracture healing: from molecular and cellular mechanisms to therapeutic strategies.Signal transduction and targeted therapy · 2026Review
- Article
- Abaloparatide and pelvic fracture healing: a phase 2 randomized placebo-controlled trial.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Article
- [Adjunctive therapies in geriatric ankle fracture patients].Unfallchirurgie (Heidelberg, Germany) · 2026Review
- Anabolics in Cancer Patients: To Use or Not to Use?Endocrinology and metabolism (Seoul, Korea) · 2026Review
- Comparative Radiologic Outcomes of Romosozumab and Teriparatide in Osteoporotic Vertebral Fractures.Journal of clinical medicine · 2026Article
- Biologics for bone regeneration: advances in cell, protein, gene, and mRNA therapies.Bone research · 2026Review
- Article
- Evaluation of testosterone and alendronate coated membranes in osteoporotic fracture and defect model in rats and goats.Journal of orthopaedic translation · 2026Article
- Contrast-Enhanced Ultrasound (CEUS) Reveals Perfusion of Human Bone in Acute Fracture Healing: A Pilot Study.Journal of orthopaedic research : official publication of the Orthopaedic Research Society · 2026Article
- Treatment with romosozumab in patients with osteoporosis on maintenance hemodialysis.Journal of bone and mineral metabolism · 2025Review
- High-dose romosozumab promoted bone regeneration of critical-size ulnar defect filled with demineralized bone matrix in nonhuman primates.Journal of orthopaedic translation · 2025Article
- Rethinking Osteoporosis Drugs: Can We Simultaneously Address Sarcopenia?International journal of molecular sciences · 2025Review
- Examining Romosozumab Adherence and Side Effects in Osteoporotic Patients After Surgical Fracture Fixation: A Comparative, Descriptive, and Hypothesis-Generating Study with Non-Fractured Controls.Diseases (Basel, Switzerland) · 2025Article
- Role of Sclerostin in Cardiovascular System.International journal of molecular sciences · 2025Review
- Managing delayed union of fragility fractures of the pelvis successfully using romosozumab: A case report.Trauma case reports · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 8 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRomosozumab is a bone-forming antibody that increases bone formation and decreases bone resorption. We conducted a double-blinded, randomized, phase-2, dose-finding trial to evaluate the effect of romosozumab on the clinical outcomes of open reduction and internal fixation of intertrochanteric or femoral neck hip fractures.
methodsPatients (55 to 94 years old) were randomized 2:3:3:3 to receive 3 subcutaneous injections of romosozumab (70, 140, or 210 mg) or a placebo postoperatively on day 1 and weeks 2, 6, and 12. The primary end point was the difference in the mean timed "Up & Go" (TUG) score over weeks 6 to 20 for romosozumab versus placebo. Additional end points included the time to radiographic evidence of healing and the score on the Radiographic Union Scale for Hip (RUSH).
resultsA total of 332 patients were randomized: 243 to receive romosozumab (70 mg, n = 60; 140 mg, n = 93; and 210 mg, n = 90) and 89 to receive a placebo. Although TUG scores improved during the study, they did not differ significantly between the romosozumab and placebo groups over weeks 6 to 20 (p = 0.198). The median time to radiographic evidence of healing was 16.4 to 16.9 weeks across treatment groups. The RUSH scores improved over time across treatment groups but did not differ significantly between the romosozumab and placebo groups. The overall safety and tolerability profile of romosozumab was comparable with that of the placebo.
conclusionsRomosozumab did not improve the fracture-healing-related clinical and radiographic outcomes in the study population. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.