Trial reportThe New England journal of medicine2009
Denosumab for prevention of fractures in postmenopausal women with osteoporosis.
Trial report in The New England journal of medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 14 registered trials, which are not on this map. Cited by 1,412 papers, 13 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 Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)
Denosumab and Male Infertility: a Prospective Intervention Study
Denosumab and Male Infertility: a Randomized Controlled Double-blinded Intervention Study
Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis
A Phase III, Randomized, Two-armed, Parallel, Double-blind, Active-controlled, Non-inferiority Clinical Trial to Determine the Non-inferior Therapeutic Efficacy and Safety Between Arylia (60 mg, Denosumab, Produced by AryoGen Pharmed) Compared With Prolia® (60 mg, Denosumab, the Reference Drug, Produced by Amgen Company) in the Improvement of Bone Mineral Densitometry (BMD) Among Osteoporotic Postmenopausal Women
Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis
Efficacy of Denosumab and Zoledronic Acid in the Treatment of Idiopathic Inflammatory Myopathies Related Reduced Bone Mineral Density: a Prospective Controlled Trial
Alendronate in an Weekly Effervescent Tablet Formulation for Preservation of Bone Mass After Denosumab Discontinuation in Postmenopausal Women with Low Bone Mass. an Observational Study (Binosto After Denosumab - the BAD Study)
Vitamin D Improves Osteoporosis in Postmenopausal Women With Denosumab Failure
Novel Treatment of Some Men With Non-Obstructive Azoospermia (NT-NOA): A Clinical Interventional Study
Copenhagen Menopause Study (COMPASS): A Randomized Clinical Trial
The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity
The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation: A Randomized Non-inferiority Trial
Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)
Who cites it
1,412 citing papers in PubMed, 13 syntheses or guidelines pooled it, 3,390 citations in OpenAlex.
- Artificial Intelligence for Evidence Synthesis of Emerging Biologics to Improve Skeletal Health in Osteogenesis Imperfecta: Systematic Review and Meta-Analysis.Journal of medical Internet research · 2026Pooled it
- Comparison of traditional and new treatments for fibrous dysplasia: a systematic review and meta-analysis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Pooled it
- Comparison of the Efficacy of Denosumab and Alendronate in Improving Bone Mineral Density in Osteoporosis Patients and High-Risk Populations: A Systematic Review and Meta-Analysis.Clinical drug investigation · 2026Pooled it
- Hypercalcemia after denosumab discontinuation in patients with osteoporosis: a systematic review and case report.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Pooled it
- Exercise for fracture prevention - evidence and consensus-based practice guideline of the osteology umbrella association (DVO).BMC endocrine disorders · 2026Guideline
- Beyond bone effects: the role of denosumab in muscle Health - A systematic review.Aging clinical and experimental research · 2026Pooled it
- Efficacy and safety of abaloparatide, denosumab, teriparatide, oral bisphosphonates, and intravenous bisphosphonates in the treatment of postmenopausal osteoporosis: a systematic review and Bayesian network meta-analysis.Frontiers in endocrinology · 2026Pooled it
- Treatment-related changes in total hip bone mineral density are applicable to trials of varied study designs and to drugs with differing mechanisms of action: meta-regression results from the FNIH-ASBMR SABRE study.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2025Pooled it
- Efficacy and safety of denosumab in treatment of osteoporosis in patients with rheumatoid arthritis: a meta-analysis and systematic review.BMC musculoskeletal disorders · 2025Pooled it
- The 2024 UK clinical guideline for the prevention and treatment of osteoporosis.Archives of osteoporosis · 2025Guideline
- A cost-saving analysis of pharmacologic management in osteoporotic fracture prevention among postmenopausal women.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025Pooled it
- Shared genetics between metabolic traits and sensorineural hearing loss: a large-scale genome-wide cross-trait analysis.Molecular genetics and genomics : MGG · 2025Pooled it
- 2024 Royal Australian College of General Practitioners and Healthy Bones Australia guideline for osteoporosis management and fracture prevention in postmenopausal women and men over 50 years of age.The Medical journal of Australia · 2025Guideline
- Efficacy of denosumab versus zoledronate on preventing secondary osteoporotic vertebral compression fracture: a prospective study with 2-year follow-up.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Trial
- Trial
- Phase 3 study comparing the efficacy and safety of proposed biosimilar RGB-14-P with denosumab in postmenopausal women with osteoporosis: results from the transition (switch) phase.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Trial
- Comparative bone histomorphometry effects of combined denosumab and teriparatide vs monotherapy in postmenopausal women with osteoporosis: a randomized controlled trial.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2026Trial
- Comparison of pharmacokinetics, pharmacodynamics, safety, and immunogenicity of a candidate biosimilar INTP23.1 with EU and US‑approved denosumab reference products in healthy adult men.Naunyn-Schmiedeberg's archives of pharmacology · 2026Trial
- 3 months vs 12 months of romosozumab for postmenopausal osteoporosis (LIDA): an open-label, non-inferiority, randomised controlled trial.The lancet. Diabetes & endocrinology · 2026Trial
- A Randomized Phase 1 Study Comparing the PK, PD, Safety, and Immunogenicity of Proposed Biosimilar RGB-14-X and Denosumab in Healthy Adult Males.Clinical and translational science · 2026Trial
1,352 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
17 authors at 10 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDenosumab is a fully human monoclonal antibody to the receptor activator of nuclear factor-kappaB ligand (RANKL) that blocks its binding to RANK, inhibiting the development and activity of osteoclasts, decreasing bone resorption, and increasing bone density. Given its unique actions, denosumab may be useful in the treatment of osteoporosis.
methodsWe enrolled 7868 women between the ages of 60 and 90 years who had a bone mineral density T score of less than -2.5 but not less than -4.0 at the lumbar spine or total hip. Subjects were randomly assigned to receive either 60 mg of denosumab or placebo subcutaneously every 6 months for 36 months. The primary end point was new vertebral fracture. Secondary end points included nonvertebral and hip fractures.
resultsAs compared with placebo, denosumab reduced the risk of new radiographic vertebral fracture, with a cumulative incidence of 2.3% in the denosumab group, versus 7.2% in the placebo group (risk ratio, 0.32; 95% confidence interval [CI], 0.26 to 0.41; P<0.001)--a relative decrease of 68%. Denosumab reduced the risk of hip fracture, with a cumulative incidence of 0.7% in the denosumab group, versus 1.2% in the placebo group (hazard ratio, 0.60; 95% CI, 0.37 to 0.97; P=0.04)--a relative decrease of 40%. Denosumab also reduced the risk of nonvertebral fracture, with a cumulative incidence of 6.5% in the denosumab group, versus 8.0% in the placebo group (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P=0.01)--a relative decrease of 20%. There was no increase in the risk of cancer, infection, cardiovascular disease, delayed fracture healing, or hypocalcemia, and there were no cases of osteonecrosis of the jaw and no adverse reactions to the injection of denosumab.
conclusionsDenosumab given subcutaneously twice yearly for 36 months was associated with a reduction in the risk of vertebral, nonvertebral, and hip fractures in women with osteoporosis. (ClinicalTrials.gov number, NCT00089791.)
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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.