Clinical efficacy of romosozumab in the treatment of elderly male patients of osteoporotic with hip fractures: a retrospective study

Background: This study aims to evaluate the efficacy and safety of romosozumab in elderly male patients with osteoporosis-associated hip fractures. Methods: A retrospective analysis was conducted using medical records from 94 elderly male patients with hip fractures who received treatment at our institution between October 2021 and March 2023. The patients were divided into two groups based on their treatment regimens: the observation group (n = 47) received monthly subcutaneous injections of 210 mg romosozumab for 12 months, and the control group (n = 47) was administered 10 mg of alendronate sodium orally each morning. Results: The results showed that the total effective rate was significantly higher in the observation group (p < 0.05), with a marginally greater rate of significant effectiveness in the observation group. Post-treatment assessments indicated significantly lower Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) scores in the observation group than the control group (p < 0.05). Bone mineral density (BMD) in the observation group was markedly higher, with significantly reduced levels of osteocalcin (OSC) and bone-specific alkaline phosphatase (BALP) (p < 0.05). Quality of life scores improved significantly in the observation group (p < 0.05), and there was no significant difference in adverse event incidence between the two groups (p > 0.05). Follow-up evaluations at 3, 6 and 12 months revealed that the observation group maintained higher BMD, osteocalcin, procollagen type 1 N-terminal propeptide (P1NP), and C-terminal telopeptide of type 1 collagen (CTx) levels, alongside a reduced incidence of fractures and adverse events compared to the control group (p < 0.05). After one year, the fracture healing rate was significantly higher in the observation group (p < 0.05). Conclusions: These findings suggest that romosozumab provides a substantial therapeutic benefit in elderly male patients with osteoporotic hip fractures, with no notable increase in adverse reactions and favorable follow-up outcomes.

Romosozumab; Osteoporosis; Hip fracture

[1] Zhang J, Hu W, Zou Z, Li Y, Kang F, Li J, et al. The role of lipid metabolism in osteoporosis: clinical implication and cellular mechanism. Genes & Diseases. 2023; 11: 101122.

[2] Eslamipour F, Gheitasi M, Hovanloo F, Yaghoubitajani Z. High versus low-intensity resistance training on bone mineral density and content acquisition by postmenopausal women with osteopenia: a randomized controlled trial. Medical Journal of the Islamic Republic of Iran. 2023; 37: 126.

[3] Yin YH, Lin YQ, Wu J, Zhao WY, Yang MX, Qiu L, et al. Investigation of prevalence rate of osteoporosis and analysis of its influencing factors in older adults in Jiuting Town, Songjiang District, Shanghai City. Chinese Journal of Preventive Medicine. 2024; 58: 1048–1054. (In Chinese)

[4] Patel R, Judge A, Johansen A, Javaid MK, Griffin XL, Chesser T, et al.; REDUCE Study Group. Following hip fracture, hospital organizational factors associated with prescription of anti-osteoporosis medication on discharge, to address imminent refracture risk: a record-linkage study. Journal of Bone and Mineral Research. 2024; 39: 1071–1082.

[5] Vollenweider N, Poblete B, Babst R, Beeres FJP, Lehnick D, Link BC. Preoperative goal directed therapy in geriatric hip fracture patients—a retrospective quality improvement study. BMC Geriatrics. 2024; 24: 959.

[6] Lu K, Wu YM, Shi Q, Gong YQ, Zhang T, Li C. The impact of acute-phase reaction on mortality and re-fracture after zoledronic acid in hospitalized elderly osteoporotic fracture patients. Osteoporosis International. 2023; 34: 1613–1623.

[7] Abu-Jwead A, Fisher DL, Goldabart A, Yoel U, Press Y, Tsur A, et al. Safety of in-hospital parenteral antiosteoporosis therapy following a hip fracture: a retrospective cohort. Journal of the Endocrine Society. 2024; 8: bvae172.

[8] Kirk JM, Rathbun AM, Gruber-Baldini AL, Hochberg MC, Magaziner J, Shardell MD, et al. Sex differences and predictors of anti-osteoporosis medication use in the 12 months after hip fracture surgery in adults 65 or older. Osteoporosis International. 2024; 35: 1943–1950.

[9] Wan SA, Tiong IK, Chuah SL, Cheong YR, Singh BSM, Lee KH, et al. Gender differences in osteoporotic hip fractures in Sarawak General Hospital. Medical Journal of Malaysia. 2023; 78: 207–212.

[10] Fujimoto K, Maki N, Hashiba D, Maeyama T, Nakagawa R, Arai H, et al. Effect of romosozumab in premenopausal women with severe osteoporosis and anorexia nervosa. Osteoporosis and Sarcopenia. 2023; 9: 137–141.

[11] Katoh M, Katoh M. Molecular genetics and targeted therapy of WNT-related human diseases (Review). International Journal of Molecular Medicine. 2017; 40: 587–606.

[12] Eriksen EF, Boyce RW, Shi Y, Brown JP, Betah D, Libanati C, et al. Reconstruction of remodeling units reveals positive effects after 2 and 12 months of romosozumab treatment. Journal of Bone and Mineral Research. 2024; 39: 729–736.

[13] Cianferotti L, Cipriani C, Palermo A, Viapiana O, Zavatta G, Mazziotti G. A practical approach for anabolic treatment of bone fragility with romosozumab. Journal of endocrinological investigation. 2024; 47: 2649–2662.

[14] Macrae F, Clark EM, Walsh K, Bailey SJ, Roy M, Hardcastle S, et al. Cardiovascular risk assessment for osteoporosis patients considering Romosozumab. Bone. 2025; 190: 117305.

[15] Bokrantz T, Manhem K, Lorentzon M, Karlsson M, Ljunggren Ö, Ohlsson C, et al. The association between peripheral arterial disease and risk for hip fractures in elderly men is not explained by low hip bone mineral density. Results from the MrOS Sweden study. Osteoporosis International. 2022; 33: 2607–2617.

[16] Codazza S, Ferrara PE, Gueli G, Ferriero G, Ronconi G. The management of knee osteoarthritis in elderly: results from a national survey compared to ESCEO guidelines. European Review for Medical and Pharmacological Sciences. 2022; 26: 24–32.

[17] Zeng J, Yang X, Lei H, Zhong X, Lu X, Liu X, et al. Enhanced postoperative pain management and mobility following arthroscopic knee surgery: a comparative study of adductor canal block with and without IPACK block. Medical Science Monitor. 2024; 30: e943735.

[18] Williams B, Johnson D. Effects of the NeuroHAB Program on low back pain and oswestry disability index scores: a retrospective wait-list control study. Journal of Functional Morphology and Kinesiology. 2024; 9: 118.

[19] Siafaka V, Mavridis D, Tsonis O, Tzamakou E, Christogiannis C, Tefa L, et al. The WHOQOL-BREF instrument: psychometric evaluation of the Greek version in patients with advanced cancer and pain and associations with psychological distress. Palliative & Supportive Care. 2024; 22: 698–708.

[20] Wang YY, Chou YC, Tsai YH, Chang CW, Chen YC, Tai TW. Unplanned emergency department visits within 90 days of hip hemiarthroplasty for osteoporotic femoral neck fractures: Reasons, risks, and mortalities. Osteoporosis and Sarcopenia. 2024; 10: 66–71.

[21] Viola R, Aslan S, Al-Smadi MW, Süvegh D, Viola Á. From detection to decision: how STIR sequence MRI influences treatment strategies for osteoporotic vertebral fractures. Journal of Clinical Medicine. 2024; 13: 3347.

[22] Mikula AL, Lakomkin N, Hamouda AM, Everson MC, Pennington Z, Kumar R, et al. Change in spinal bone mineral density as estimated by Hounsfield units following osteoporosis treatment with romosozumab, teriparatide, denosumab, and alendronate: an analysis of 318 patients. Journal of Neurosurgery: Spine. 2024; 41: 309–315.

[23] Giampà E, Celletti E, DI Bonito M, Ferretti V, Gigliotti P, Nuvoli G, et al. Safety and effects of calcifediol 0.266 milligrams soft capsules monthly and cholecalciferol 25000 international units monthly in osteoporotic women undergoing therapy with alendronate: a cross-sectional study. Minerva Endocrinology. 2024; 49: 141–149.

[24] Chen J, Zheng J, Chen M, Lin S, Lin Z. The efficacy and safety of Chinese herbal medicine Xianling Gubao capsule combined with alendronate in the treatment of primary osteoporosis: a systematic review and meta-analysis of 20 randomized controlled trials. Frontiers in Pharmacology. 2021; 12: 695832.

[25] Nguyen PV, Bouin M, Ste-Marie LG. Upper gastrointestinal safety of oral bisphosphonate in hospitalized patients. Osteoporosis International. 2021; 32: 193–197.

[26] Vestergaard Kvist A, Faruque J, Vallejo-Yagüe E, Weiler S, Winter EM, et al. Cardiovascular safety profile of romosozumab: a pharmacovigilance analysis of the us food and drug administration adverse event reporting system (FAERS). Journal of Clinical Medicine. 2021; 10: 1660.

[27] Hayashi K. Efficacy of three teriparatide preparations and romosozumab, osteogenesis promoters, in the treatment of fresh vertebral fractures: a retrospective observational study. Drugs: Real World Outcomes. 2024; 11: 341–342.

[28] Brown JP, Engelke K, Keaveny TM, Chines A, Chapurlat R, Foldes AJ, et al. 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. Journal of Bone and Mineral Research. 2021; 36: 2139–2152.

[29] Miller PD, Adachi JD, Albergaria BH, Cheung AM, Chines AA, Gielen E, et al. Efficacy and safety of romosozumab among postmenopausal women with osteoporosis and mild-to-moderate chronic kidney disease. Journal of Bone and Mineral Research. 2022; 37: 1437–1445.

[30] Mineta K, Nishisho T, Okada M, Kamada M, Sairyo K. Real-world effects, safety, and predictors of the effectiveness of romosozumab in primary and secondary osteoporosis: an observational study. Bone. 2024; 186: 117164.

[31] Kobayashi T, Hara M, Shimanoe C, Morimoto T, Masaaki M, Ito K, et al. Efficacy and safety of romosozumab: a meta-analysis of placebo-controlled trials. Journal of Bone and Mineral Metabolism. 2024; 42: 492–502.

[32] Kobayakawa T, Kanayama Y, Hirano Y, Nakamura Y. Comparison of Denosumab with Romosozumab in the treatment of male osteoporosis: a retrospective cohort study. Scientific Reports. 2024; 14: 22785.

[33] Masuda S, Fukasawa T, Matsuda S, Yoshida S, Kawakami K. Comparative effectiveness and cardiovascular safety of romosozumab versus teriparatide in patients with osteoporosis: a population-based cohort study. Osteoporosis International. 2024; 35: 2165–2174.

[34] Xu L, Liu B, Ma H, Qi E, Ma J, Chang T, et al. O-GlcNAc transferase promotes vascular smooth muscle calcification through modulating Wnt/β-catenin signaling. The FASEB Journal. 2024; 38: e70271.

[35] Yong MHA, Seng JJB, Tan YLC, Wong J, How P. Prevalence and outcomes associated with hypocalcaemia and hypercalcaemia among pre-dialysis chronic kidney disease patients with mineral and bone disorder. Singapore Medical Journal. 2024; 65: 421–429.