Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB - LARVOL DELTA

Safety and efficacy of the use of anabolic bone agents in patients with underlying plasma cell dyscrasias: A case series. (ASH 2025) - "Results : •Sample Size: 12 patients (10F, 2M) •Age: Mean 71 years (range 60–88) •Race : All White •Bone Diagnosis : Osteoporosis (n=12) •Plasma Cell Diagnosis: MGUS (n=9), MGRS (n=1), MM (n=2) •Timing: Median interval between bone and hematologic diagnosis was 4 years (range: -10 to +39 years), indicating bone disease often preceded hematologic diagnosis •Anabolic Agents Used: Teriparatide (n=5), Abaloparatide (n=4), Romosozumab (n=3) •Therapy Duration: Mean 18 months (range 12–24 months) •Anabolic Agent Prescribing Specialties: Endocrinology (n=7), Osteology (n=2), Family Medicine (n=2), Rheumatology (n=1) •DEXA T-score Change: Mean improvement of +0.2 (range -0.7 to +1.3) over an average interval of 2.1 years - Baseline T-score: Mean -2.4 - Most recent T-score: Mean -2.2 •Oncology Status at Follow-Up: -Stable MGUS (n=8) -Active MM (n=1) -Deceased (non-PCD-related causes) (n=2) -Lost to follow-up (n=1) Conclusions : In this case series anabolic bone therapy was not..."

Clinical • Amyloidosis • Endocrine Disorders • Hematological Malignancies • Monoclonal Gammopathy • Multiple Myeloma • Musculoskeletal Diseases • Rheumatology • Smoldering Multiple Myeloma

Individual and Community-level Determinants of Osteoporosis Treatment Following Fracture Among Medicare Beneficiaries. (PubMed, J Gen Intern Med) - "OP treatment after fracture remains suboptimal-especially among men-despite clear guidelines. Engagement with preventive care was strongly associated with treatment initiation. Community socioeconomic disadvantage and depression were also important barriers to post-fracture treatment, with sex-specific patterns. Integrating fracture-care pathways into preventive visits and focusing on socioeconomically disadvantaged communities could improve secondary fracture prevention."

Journal • Medicare • Reimbursement • US reimbursement • CNS Disorders • Depression • Infectious Disease • Influenza • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Pneumococcal Infections • Preventive care • Psychiatry • Respiratory Diseases • Rheumatology

Renal function predicts 12-month response to romosozumab readministration after denosumab in women with osteoporosis. (PubMed, Arch Osteoporos) - "Lower baseline eGFR was an independent predictor of greater LS or TH BMD response to romosozumab readministration after denosumab, with an optimal cutoff value of 54 mL/min/1.73 m2. Larger studies are needed to validate these findings."

Clinical • Journal • Osteoporosis • Rheumatology

Romosozumab and Denosumab Combination Therapy After Denosumab in Postmenopausal Osteoporosis. (PubMed, Arthritis Rheumatol) - "Ongoing treatment with denosumab did not blunt the anabolic response of romosozumab, indicating sustained modeling-based bone formation activity. Adding romosozumab in patients failing denosumab might be a valuable option."

Journal • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

How to optimize the use of anti-osteoporotic medication in clinical practice? (PubMed, Expert Opin Pharmacother) - "New data are available to guide the choice of start and sequence of anti-resorptives and osteo-anabolics according to the level of fracture risk in postmenopausal women, in patients treated with glucocorticoids, after a hip fracture and in patients treated with a treat to target strategy. Integrating FRAX, the level of aBMD, a detailed fracture history including imaging of the spine, and additional risk factors contributes to decide on treatment with antiresorptive-treatment (in high-risk subjects) and osteoanabolic-treatment (in very high-risk subjects) and their sequence to achieve a target with a low fracture risk which needs lifelong follow up for further diagnostic and treatment decisions."

Journal • Review • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

The efficacy and safety of romosozumab sequential therapy in postmenopausal women: A systematic review and meta-analysis. (PubMed, J Orthop) - "Sequential treatment with romosozumab followed by anti-resorptive agents (e.g., denosumab, alendronate) significantly reduced fracture incidence and increased BMD at the lumbar spine, total hip, and femoral neck compared to non-sequential therapy. Romosozumab sequential therapy may reduce fracture risk and improve BMD in postmenopausal women with osteoporosis, without a significant increase in short-term adverse events. However, evidence regarding new vertebral fractures and certain BMD outcomes remains limited in robustness, warranting further validation through high-quality, long-term studies."

Journal • Retrospective data • Review • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Vertebral changes evaluated by hounsfield units after spinal fusion surgery with concomitant anabolic therapy. (PubMed, Arch Osteoporos) - "Perioperative administration of TPD and ROMO significantly improved vertebral bone density, as determined by HU values. ROMO demonstrated a more pronounced effect than TPD, suggesting that it may be the preferred option for optimizing bone density in patients undergoing spinal fusion surgery."

Journal • Retrospective data • Osteoporosis • Rheumatology

Drugs against osteoporosis in perimenopausal and postmenopausal women. (PubMed, Front Med (Lausanne)) - "Commonly used anti-resorptive drugs include bisphosphonates, denosumab, hormone replacement therapy, and raloxifene...Common examples include teriparatide, romosozumab, and parathyroid hormone...Phytoestrogens. These are non-steroidal, naturally occurring plant compounds with estrogenic and/or anti-estrogenic properties that resemble estrogen."

Journal • Review • Osteoporosis • Rheumatology

The Conundrum of Medical Fracture Prevention in Chronic Kidney Disease-Summary of the Evidence and Pragmatic Clinical Guidance. (PubMed, J Clin Med) - "This review summarizes the available evidence regarding fracture risk and bone mineral density including pragmatic clinical guidance for the use of calcium, vitamin D, phosphate binders, calcimimetics, bisphosphonates, denosumab, romosozumab, and teriparatide in patients with advanced non-dialysis CKD, on dialysis, and after kidney transplantation. For teriparatide, the limited evidence in patients with low bone turnover disease is evaluated. The review navigates the available evidence and unresolved controversies across therapeutic options, and provides pragmatic guidance to support individualized clinical decision-making."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Endocrine Disorders • Musculoskeletal Diseases • Nephrology • Orthopedics • Osteoporosis • Renal Disease • Rheumatology • Transplantation

The preclinical discovery and development of romosozumab for the treatment of people with severe osteoporosis who are at high risk of fracture. (PubMed, Expert Opin Drug Discov) - "Furthermore, sequential treatment, switching romosozumab over to denosumab, reduced the risk of vertebral fractures compared to switching the placebo to denosumab. An imbalance in cardiovascular events was found when using romosozumab in comparison to alendronate but not versus placebo. Romosozumab was eventually approved by EMA and FDA in 2019 for the treatment of patients with very high risk of fractures while considering their cardiovascular risk and is available and reimbursed in many countries."

Journal • Preclinical • Cardiovascular • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology • SOST

Romosozumab-Induced Epidural Calcification in a Hemodialysis Patient. (PubMed, Cureus) - "Awareness of this phenomenon is crucial to avoid misdiagnosis as recurrent infection, to prevent unnecessary interventions, and to ensure timely discontinuation of the offending agent. Further recognition may help refine monitoring strategies and guide safer use of osteoanabolic agents in high-risk populations."

Journal • Back Pain • Chronic Kidney Disease • Infectious Disease • Lumbar Back Pain • Musculoskeletal Pain • Nephrology • Osteoporosis • Pain • Renal Disease • Rheumatology

Cardiovascular Risk of Romosozumab vs. Teriparatide: A Cohort Study Using Japan's National Claims Database. (PubMed, Clin Pharmacol Ther) - "In subgroup analyses based on MACE history, the aHRs (95% CI) for no history, for the one-year period leading up to t0, and for more than 1 year before t0 were 1.01 (0.95-1.08), 0.93 (0.72-1.21), and 1.00 (0.85-1.18), respectively. In conclusion, no statistically significant difference in MACE risk was observed between romosozumab and teriparatide in Japan's national claims database, regardless of MACE history."

Journal • Cardiovascular

Clinical outcomes of twice-weekly teriparatide acetate administration in osteoporosis. (PubMed, Arch Osteoporos) - "The continuation rate of W2TPD was 47% and resulted in particularly favorable BMD gains in the spine. It was also discovered to be effective in increasing BMD even when following bisphosphonate treatment."

Clinical data • Journal • Gastroenterology • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Treatment patterns of romosozumab in postmenopausal women with severe osteoporosis in Denmark: findings from the ROmosozumab in Scandinavia real-world Evidence Study (ROSES). (PubMed, Osteoporos Int) - "This study provides real-world insight into patient and prescriber characteristics, and patterns and factors of romosozumab use across Denmark. Whilst a notable proportion of patients received romosozumab first in sequential therapy, there is still opportunity to optimize bone mineral density (BMD) outcomes with osteoanabolic agents used first, followed by an antiresorptive, in patients at high fracture risk. Of romosozumab-treated patients with 15 months follow-up data, most were assumed to continue romosozumab for 11-15 months when treatment transition was recorded. Real-world data from Danish registries were used to describe treatment patterns with romosozumab and other anti-osteoporosis treatments in postmenopausal women with osteoporosis. The study found romosozumab‑treated patients were younger and had fewer comorbidities than other osteoporosis patients. Among romosozumab-treated patients, 44.5% were treatment-naïve and most continued with romosozumab for..."

HEOR • Journal • Real-world evidence • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Sequence treatment of postmenopausal osteoporosis (PubMed, Ugeskr Laeger) - "Initial therapy for low-risk patients typically involves potent antiresorptive agents such as bisphosphonates or denosumab to reduce bone resorption and fracture risk. For high-risk patients, bone anabolic agents like teriparatide or romosozumab may be preferred to stimulate bone formation, rapidly increase bone mass and enhance fracture prevention. Effective transitions between therapies are essential to sustain skeletal benefits. This review explores evidence-based strategies for sequential osteoporosis treatment."

Journal • Review • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Recent Advances in Osteoporosis Therapeutics. (PubMed, Annu Rev Med) - "Current therapies for osteoporosis include antiresorptive treatments, including bisphosphonates, denosumab, and raloxifene, and osteoanabolic treatments, including teriparatide, abaloparatide, and romosozumab, which is a dual-action agent. Recent guidelines have suggested categorical risk stratification and a goal-directed individualized therapy strategy. New treatments under investigation also hold promise for further improving bone health in postmenopausal osteoporosis."

Journal • Review • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Nitin Agarwal | Initiation date: Jun 2025 ➔ Dec 2025

Trial initiation date • Orthopedics • Osteoporosis • Rheumatology

Author response to letter to the editor, "Comment on "Impact of baseline PINP on the BMD increase with romosozumab, teriparatide, and denosumab in treatment-naïve primary osteoporosis: A retrospective cohort study"". (PubMed, Bone) - No abstract available

Journal • Retrospective data • Osteoporosis • Rheumatology

Romosozumab for Treatment of Osteoporosis in Advanced CKD: Series from Real-World Evidence (KIDNEY WEEK 2025) - "Additionally, hypocalcemia was a frequent adverse event. These findings suggest a potentially blunted skeletal response to romosozumab in CKD and underscore the need for prospective studies to better assess its efficacy and safety in this population."

Clinical • HEOR • Metastases • Real-world • Real-world evidence • Cardiovascular • Chronic Kidney Disease • Endocrine Disorders • Musculoskeletal Diseases • Nephrology • Orthopedics • Osteoporosis • Renal Disease • Rheumatology

Romosozumab Improves Bone Mineral Density and Quality of Life in Sickle Cell Associated Osteopenia and Osteoporosis (ASH 2024) - "She is on hydroxyurea, folic acid, painkillers, blood transfusion, and iron chelation...BMD of the hip joint increased from 0.756 to 0.882 g/cm2 with an increase in T-score from -3 to -1 SDDiscussion : treatment of metabolic bone disease in patients with sickle cell disease has included Vitamin D with Calcium supplement, bisphosphonate, and denosumab with various degrees of improvement in bone pain, however, none of these have shown an increase in BMD1-4. Our case is the first to show dramatic pain reduction and increased BMD with improved QOL.Conclusion : Romosozumab may increase BMD, reduce bone pain, and improve QOL in sickle cell patients with metabolic disease. This finding needs confirmation through larger studies."

HEOR • Anemia • Genetic Disorders • Hematological Disorders • Metabolic Disorders • Musculoskeletal Pain • Orthopedics • Osteoporosis • Pain • Rheumatology • Sickle Cell Disease

Comparative Cardiovascular Safety of Romosozumab and Denosumab in Osteoporosis Treatment: A Multinational Real-World Cohort Study (ISPOR-EU 2025) - "Romosozumab may be a feasible and safe treatment option for osteoporosis, as it was not significantly associated with increased cardiovascular risk or mortality. However, in patients with a history of cardiovascular disease, the use of romosozumab should be approached with caution due to the potential long-term risk of PAD."

Clinical • Real-world • Real-world evidence • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Osteoporosis • Peripheral Arterial Disease • Rheumatology

Age-related response to 12-month romosozumab in treatment-naïve Japanese women aged 55-100 years with primary osteoporosis. (PubMed, Bone) - "No significant associations were observed for TH or FN BMD or the bone turnover markers. An inverse linear relationship was observed between age and percent change of the LS BMD at 6 months; however, the relationship was not robust at 12 months."

Journal • Osteoporosis • Rheumatology

Considerations Regarding the Use of Romosozumab in a Patient at High Risk for Cardiovascular Disease. (PubMed, J Bone Miner Res) - "Romosozumab is contraindicated for patients at very high risk of CV disease, and clinicians are advised to consider the skeletal benefits vs potential CV risks in patients with CV risk factors. The background information leading to that contraindication and recent real-world evidence about the relationship between romosozumab and CV risk is reviewed to aid in the discussion with the patient and her primary care provider."

Journal • Cardiovascular • Dyslipidemia • Hypertension • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Bone mineral density response to romosozumab in post-menopausal women: A prospective observational real-world study. (PubMed, Bone) - "Baseline BMD was associated with total hip BMD response to romosozumab. Age itself was not associated with BMD differences. Our data support the effectiveness of romosozumab in older postmenopausal women in routine clinical practice."

Journal • Observational data • Real-world evidence • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture. (clinicaltrials.gov) - P4 | N=100 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

Trial completion • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology