Trial reportJournal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research2021
Romosozumab improves lumbar spine bone mass and bone strength parameters relative to alendronate in postmenopausal women: results from the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH) trial.
Trial report in Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 47 papers, 2 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 Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures
Who cites it
47 citing papers in PubMed, 2 syntheses or guidelines pooled it, 71 citations in OpenAlex.
- Effects of romosozumab combined with routine therapy on pain relief, disease progression and adverse reactions in patients with postmenopausal osteoporosis: a systematic review and meta-analysis.Frontiers in medicine · 2024Pooled it
- Fracture risk reduction and safety by osteoporosis treatment compared with placebo or active comparator in postmenopausal women: systematic review, network meta-analysis, and meta-regression analysis of randomised clinical trials.BMJ (Clinical research ed.) · 2023Pooled it
- Romosozumab Improves Tissue Thickness-Adjusted Trabecular Bone Score in Women With Osteoporosis and Diabetes.The Journal of clinical endocrinology and metabolism · 2025Trial
- Romosozumab improves microarchitecture as assessed by tissue thickness-adjusted trabecular bone score in postmenopausal women with osteoporosis.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2025Trial
- 3D-modeling from hip DXA shows improved bone structure with romosozumab followed by denosumab or alendronate.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2024Trial
- Trial
- Effects of romosozumab on the peripheral and axial skeleton in postmenopausal women at high fracture risk: real-world evidence from DXA and HR-pQCT data.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Article
- Different Lrp5-HBM mutations induce magnitude- and surface-selective effects that are not explained by receptor trafficking.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2026Article
- Prescription of off-label medications in patients on dialysis: time to challenge contraindications?Clinical kidney journal · 2026Review
- 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
- Clarifying clinically treatment-naive status for osteoporosis patients.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Review
- Sclerostin in Vascular Calcification: Hypoxia-Driven Regulation and Therapeutic Modulation by Natural Products.Current atherosclerosis reports · 2026Review
- Disuse Bone Loss After Spinal Cord Injury: Scope and Challenges, Potential Mechanisms, Treatment, and Future Directions.Journal of the Endocrine Society · 2026Review
- Efficacy and safety of romosozumab in patients with chronic kidney disease and osteoporosis: a narrative review.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Review
- Article
- A beneficial effect of a novel DKK1 monoclonal antibody and its sequential alendronate on bone and muscle properties of orchiectomized mice.Journal of orthopaedic translation · 2026Article
- Effect of Disodium Etidronate on Bone Mineral Density in Postmenopausal Women: A Six-Month Prospective Study.International journal of women's health · 2026Article
- Treatment patterns of romosozumab in postmenopausal women with severe osteoporosis in Denmark: findings from the ROmosozumab in Scandinavia real-world Evidence Study (ROSES).Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Article
- Novel Insight into the Therapeutic Targets for Spinal Degenerative Diseases Gained by a Post-Genome-Wide Association Study.International journal of medical sciences · 2026Article
- Bone Optimization for Perioperative Spine Patients: A Multidisciplinary Approach at a Single Academic Center.Journal of clinical medicine · 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
15 authors at 13 institutions in 10 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH) trial (NCT01631214; https://clinicaltrials.gov/ct2/show/NCT01631214) showed that romosozumab for 1 year followed by alendronate led to larger areal bone mineral density (aBMD) gains and superior fracture risk reduction versus alendronate alone. aBMD correlates with bone strength but does not capture all determinants of bone strength that might be differentially affected by various osteoporosis therapeutic agents. We therefore used quantitative computed tomography (QCT) and finite element analysis (FEA) to assess changes in lumbar spine volumetric bone mineral density (vBMD), bone volume, bone mineral content (BMC), and bone strength with romosozumab versus alendronate in a subset of ARCH patients. In ARCH, 4093 postmenopausal women with severe osteoporosis received monthly romosozumab 210 mg sc or weekly oral alendronate 70 mg for 12 months, followed by open-label weekly oral alendronate 70 mg for ≥12 months. Of these, 90 (49 romosozumab, 41 alendronate) enrolled in the QCT/FEA imaging substudy. QCT scans at baseline and at months 6, 12, and 24 were assessed to determine changes in integral (total), cortical, and trabecular lumbar spine vBMD and corresponding bone strength by FEA. Additional outcomes assessed include changes in aBMD, bone volume, and BMC. Romosozumab caused greater gains in lumbar spine integral, cortical, and trabecular vBMD and BMC than alendronate at months 6 and 12, with the greater gains maintained upon transition to alendronate through month 24. These improvements were accompanied by significantly greater increases in FEA bone strength (p < 0.001 at all time points). Most newly formed bone was accrued in the cortical compartment, with romosozumab showing larger absolute BMC gains than alendronate (p < 0.001 at all time points). In conclusion, romosozumab significantly improved bone mass and bone strength parameters at the lumbar spine compared with alendronate. These results are consistent with greater vertebral fracture risk reduction observed with romosozumab versus alendronate in ARCH and provide insights into structural determinants of this differential treatment effect. © 2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
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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.