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Peptide

Romosozumab (Evenity)

Romosozumab (Evenity) is a humanized monoclonal antibody that inhibits sclerostin, a key negative regulator of bone formation. FDA-approved in April 2019 for postmenopausal women with osteoporosis at high fracture risk. It has a unique dual mechanism: stimulating bone formation while reducing bone resorption. The FRAME and ARCH trials demonstrated significant reductions in vertebral and clinical fractures.

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Best evidence
Grade A
Conditions studied
2
Outcomes
11
Graded outcomes
8201

Evidence by condition

  • Strong
  • Moderate
  • Limited
  • Very limited

2 conditions, plus general outcomes

Osteoporosis

Osteoporosis: outcomes studied for Romosozumab (Evenity)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Clinical Fracture Risk

FRAME trial showed lower risk of clinical fractures (composite of nonvertebral and symptomatic vertebral) with romosozumab vs placebo at 12 months.

Improves (the measure goes down)Moderate effect22 studies

Studies that measured clinical fracture risk

and 12 more in the citations list

Vertebral Fracture Risk

FRAME trial showed 73% reduction in new vertebral fractures at 12 months (0.5% vs 1.8% placebo, P<0.001). ARCH showed 48% lower risk vs alendronate at 24 months.

Improves (the measure goes down)Large effect21 studies

Studies that measured vertebral fracture risk

and 11 more in the citations list

Hip Fracture Risk

ARCH trial showed reduced hip fracture risk with romosozumab-to-alendronate sequence vs alendronate alone.

Improves (the measure goes down)Moderate effect21 studies

Studies that measured hip fracture risk

and 11 more in the citations list

Total Hip BMD

ARCH showed 6.3% increase in total hip BMD at 12 months with romosozumab vs 2.9% with alendronate (P<0.001).

Improves (the measure goes up)Large effect15 studies

Studies that measured total hip bmd

and 5 more in the citations list

Lumbar Spine BMD

Significant increases in lumbar spine BMD with romosozumab treatment, greater than placebo, alendronate, and teriparatide at 12 months.

Improves (the measure goes up)Large effect15 studies

Studies that measured lumbar spine bmd

and 5 more in the citations list

Femoral Neck BMD

Substantial gains in femoral neck BMD with romosozumab, contributing to reduced hip fracture risk.

Improves (the measure goes up)Large effect15 studies

Bone Health

Bone Health: outcomes studied for Romosozumab (Evenity)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Bone Formation Markers

Romosozumab rapidly increases bone formation markers (P1NP) with peak at 2 weeks, demonstrating its anabolic effect.

Improves (the measure goes up)Large effect17 studies

Studies that measured bone formation markers

and 7 more in the citations list

Bone Resorption Markers

Romosozumab reduces bone resorption markers (CTX), demonstrating its unique dual mechanism of action.

Improves (the measure goes down)Moderate effect17 studies

Studies that measured bone resorption markers

and 7 more in the citations list

General

General: outcomes studied for Romosozumab (Evenity)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Safety/Tolerability

17 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Moderate effect17 studies

Studies that measured safety/tolerability

and 7 more in the citations list

Bone Mineral Density

63 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Moderate effect15 studies

Studies that measured bone mineral density

and 5 more in the citations list

Kidney Function

2 preclinical studies support this finding. Primarily preclinical evidence.

Improves (the measure goes up)Small effect7 studies

Studies that measured kidney function

Key findings

  • Clinical Fracture RiskOsteoporosisImproves (the measure goes down)
  • Vertebral Fracture RiskOsteoporosisImproves (the measure goes down)
  • Hip Fracture RiskOsteoporosisImproves (the measure goes down)

Safety notes in the studies

  • FRAME trial showed lower risk of clinical fractures (composite of nonvertebral and symptomatic vertebral) with romosozumab vs placebo at 12 months.
  • ARCH showed 48% lower risk vs alendronate at 24 months.
  • ARCH trial showed reduced hip fracture risk with romosozumab-to-alendronate sequence vs alendronate alone.

Studies cited

44 studies from PubMed

  1. Cardiovascular Safety of Romosozumab vs PTH Analogues for Osteoporosis Treatment: A Propensity-Score-Matched Cohort Study.The Journal of clinical endocrinology and metabolism, 2025 · PMID 38482603
  2. Cardiovascular Safety of Romosozumab Compared to Commonly Used Anti-osteoporosis Medications in Postmenopausal Osteoporosis: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials.Drug safety, 2025 · PMID 39227560
  3. Romosozumab for the treatment of osteoporosis - a systematic review.Journal of endocrinological investigation, 2025 · PMID 39487940
  4. Assessing the Efficacy of Romosozumab in Postmenopausal Osteoporosis: An Updated Systematic Review and Meta-analysis.Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases, 2025 · PMID 40323656
  5. Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trialsOsteoporos Int, 2024 · PMID 38573517
  6. Cardiovascular Safety and Romosozumab-The Plot Thickens.The Journal of clinical endocrinology and metabolism, 2024 · PMID 38717942
  7. Impact of osteoporosis and osteoporosis medications on fracture healing: 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, 2024 · PMID 38587674
  8. Efficacy and safety of romosozumab: a meta-analysis of placebo-controlled trials.Journal of bone and mineral metabolism, 2024 · PMID 38977437
  9. A breakthrough in the management of postmenopausal osteoporosis with very high fracture risk: romosozumab (Evenity), a humanized monoclonal anti-sclerostin antibodyRev Med Liege, 2023 · PMID 37067842
  10. Evaluation of the efficacy and safety of romosozumab (evenity) for the treatment of osteoporotic vertebral compression fracture in postmenopausal women: A systematic review and meta-analysis of randomized controlled trials (CDM-J).Pharmacoepidemiology and drug safety, 2023 · PMID 36703260
  11. 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, 2022 · PMID 34432115
  12. Efficacy and Safety of Romosozumab Among Postmenopausal Women With Osteoporosis and Mild-to-Moderate Chronic Kidney Disease.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2022 · PMID 35466448
  13. Romosozumab for the treatment of osteoporosis in women: Efficacy, safety, and cardiovascular risk.Women's health (London, England), 2022 · PMID 36154750
  14. Romosozumab and Renal Function.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2022 · PMID 35869697
  15. Osteoporosis: A Review of Novel Agents.Orthopedic nursing, 2022 · PMID 36413668
  16. 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) trialBone, 2021 · PMID 34190361
  17. Romosozumab: a Review of Efficacy, Safety, and Cardiovascular Risk.Current osteoporosis reports, 2021 · PMID 33409990
  18. Romosozumab and cardiovascular safety in Japan.Osteoporosis and sarcopenia, 2021 · PMID 34632110
  19. Romosozumab versus Teriparatide for the Treatment of Postmenopausal Osteoporosis: A Systematic Review and Meta-analysis through a Grade Analysis of Evidence.Orthopaedic surgery, 2021 · PMID 34643048
  20. Romosozumab: A Review in Postmenopausal OsteoporosisDrugs Aging, 2020 · PMID 32909197
  21. Romosozumab: A Novel Agent in the Treatment for Postmenopausal OsteoporosisJ Osteoporos, 2020 · PMID 34752536
  22. Romosozumab or alendronate for fracture prevention in East Asian patients: a subanalysis of the phase III, randomized ARCH studyJ Bone Miner Metab, 2020 · PMID 32047951
  23. Nonclinical cardiovascular safety evaluation of romosozumab, an inhibitor of sclerostin for the treatment of osteoporosis in postmenopausal women at high risk of fractureRegul Toxicol Pharmacol, 2020 · PMID 32590049
  24. Safety of Romosozumab in Osteoporotic Men and Postmenopausal Women: A Meta-Analysis and Systematic Review.Monoclonal antibodies in immunodiagnosis and immunotherapy, 2020 · PMID 32195618
  25. Denosumab or romosozumab therapy and risk of cardiovascular events in patients with primary osteoporosis: Systematic review and meta- analysis.Bone, 2020 · PMID 31678488
  26. Romosozumab (sclerostin monoclonal antibody) for the treatment of osteoporosis in postmenopausal women: A review.Journal of population therapeutics and clinical pharmacology = Journal de la therapeutique des populations et de la pharmacologie clinique, 2020 · PMID 31922699
  27. Denosumab, raloxifene, romosozumab and teriparatide to prevent osteoporotic fragility fractures: a systematic review and economic evaluation.Health technology assessment (Winchester, England), 2020 · PMID 32588816
  28. Romosozumab, clinical trials, and real-world care of patients with osteoporosis.Annals of translational medicine, 2020 · PMID 32953774
  29. Romosozumab: First Global ApprovalDrugs, 2019 · PMID 30805895
  30. Increased bone mineral density for 1 year of romosozumab, vs placebo, followed by 2 years of denosumab in the Japanese subgroup of the pivotal FRAME trial and extensionArch Osteoporos, 2019 · PMID 31168657
  31. Efficacy of Pharmacological Therapies for the Prevention of Fractures in Postmenopausal Women: A Network Meta-Analysis.The Journal of clinical endocrinology and metabolism, 2019 · PMID 30907957
  32. FRAME Study: The Foundation Effect of Building Bone With 1 Year of Romosozumab Leads to Continued Lower Fracture Risk After Transition to DenosumabJ Bone Miner Res, 2018 · PMID 29573473
  33. Romosozumab treatment in postmenopausal women with osteoporosis: a meta-analysis of randomized controlled trials.Climacteric : the journal of the International Menopause Society, 2018 · PMID 29424257
  34. Effects of 24 Months of Treatment With Romosozumab Followed by 12 Months of Denosumab or Placebo in Postmenopausal Women With Low Bone Mineral Density: A Randomized, Double-Blind, Phase 2, Parallel Group Study.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2018 · PMID 29694685
  35. A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis.The Journal of clinical endocrinology and metabolism, 2018 · PMID 29931216
  36. Romosozumab or Alendronate for Fracture Prevention in Women with OsteoporosisN Engl J Med, 2017 · PMID 29231849
  37. Romosozumab for the treatment of osteoporosis.Expert opinion on biological therapy, 2017 · PMID 28064540
  38. Osteoporosis, an Update.Journal of clinical densitometry : the official journal of the International Society for Clinical Densitometry, 2017 · PMID 28449814
  39. Profile of romosozumab and its potential in the management of osteoporosis.Drug design, development and therapy, 2017 · PMID 28458516
  40. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial.Lancet (London, England), 2017 · PMID 28755782
  41. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis.The New England journal of medicine, 2017 · PMID 28892457
  42. Romosozumab Treatment in Postmenopausal Women with OsteoporosisN Engl J Med, 2016 · PMID 27641143
  43. Romosozumab in postmenopausal women with low bone mineral density.The New England journal of medicine, 2014 · PMID 24382002
  44. Osteoporosis: now and the future.Lancet (London, England), 2011 · PMID 21450337