Clinical efficacy and safety of drug interventions for primary and secondary prevention of osteoporotic fractures in postmenopausal women: Network meta-analysis followed by factor and cluster analysis

Wen, Fei; Du, Hongheng; Ding, Liang-Liang; Hu, Jianbo; Huang, Zifeng; Hua, Huang; Li, Kaikai; Mo, Yuxia; Kuang, Anyin

doi:10.1371/journal.pone.0234123

Cited by 15 publications

(13 citation statements)

References 63 publications

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“…This is further complicated by the limited evidence for falls prevention in patients with cognitive impairment [25]. In contrast, there is consistent evidence for the effectiveness of AOMs in patients with high fracture risk [26], post hip fracture [27] and with cognitive impairment [28]. The challenges for effective secondary fracture prevention using AOMs occur at the system, pharmacological, and patient level [9,29].…”

Section: Discussionmentioning

confidence: 99%

Subsequent hip fractures in patients identified by a Fracture Liaison Service (FLS) in England and Wales – linkage of the national FLS and Hip Fracture databases

Javaid

Mohsin

Johansen

et al. 2022

Preprint

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Fracture Liaison Services (FLSs) are recommended healthcare models to deliver secondary fracture prevention and reduce the risk of subsequent fractures. Several studies have demonstrated the cost and clinical effectiveness of FLSs, but there is little real-world data on the impact of FLSs on subsequent hip fracture rates. A cohort of 50,214 patients from the national FLS database with an index fracture of the hip, spine, or other site England and Wales in 2017 was linked to the National Hip Fracture Database from 2017 to 2020 to identify those patients who went on to have a subsequent hip fracture. One in twenty (5.1%) of the 9,888 people in whom the index fracture was at the hip went on to suffer a second hip fracture within 3-4 years, despite receiving the support of an FLS. The risk of hip fracture was similar (4.7%) if the index fracture was at the spine, but lower at other sites (2.8%, p<0.001) and the interval shortest after an index hip fracture (1.1 years (0.4,2.0) p<0.001). The proportion of patients with a subsequent hip fracture was not lower by types of anti-osteoporotic medication. This work highlights the need for alternative anti-osteoporotic management strategies to rapidly decrease the risk of subsequent hip fractures for people seen by an FLS setting with levels of risk that are even higher for patients in areas which are still not served by an FLS.

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Section: Discussionmentioning

confidence: 99%

Subsequent hip fractures in patients identified by a Fracture Liaison Service (FLS) in England and Wales – linkage of the national FLS and Hip Fracture databases

Javaid

Mohsin

Johansen

et al. 2022

Preprint

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“…In a recent meta-analysis including only randomized controlled trials comparing different drugs for the management of postmenopausal osteoporosis, romosozumab depicted the lowest rate of new vertebral fractures [ 94 ]. A sophisticated network meta-analysis reported that while romosozumab, teriparatide, denosumab, and risedronate are the optimal treatments for secondary prevention of osteoporotic fractures in the setting of postmenopausal osteoporosis, only zoledronate has been shown to significantly reduce both vertebral and non-vertebral fractures for primary prevention in this setting [ 95 ]. Conversely, Ding and colleagues stratified various osteoporosis drugs in postmenopausal women either with or without prevalent vertebral fracture and observed that romosozumab was the only drug that could reduce clinical and vertebral fractures in both populations [ 96 ].…”

Section: Monoclonal Antibodies Against Sclerostin In Human Osteopomentioning

confidence: 99%

“…Mariscal et al performed a meta-analysis in men and women treated with romosozumab and described that adverse effects of romosozumab were comparable to placebo, except for an increased risk of adverse reactions at the injection site [ 104 ]. An extensive network meta-analysis on primary and secondary prevention of osteoporotic fractures demonstrated a tolerability and acceptability similar between romosozumab, teriparatide, and denosumab compared to placebo [ 95 ]. In summary, romosozumab appears to be a safe and well-tolerated drug.…”

Section: Safety Profile Of Romosozumabmentioning

confidence: 99%

Osteoporosis Treatment with Anti-Sclerostin Antibodies—Mechanisms of Action and Clinical Application

Rauner

Taipaleenmäki

Tsourdi

et al. 2021

JCM

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Osteoporosis is characterized by reduced bone mass and disruption of bone architecture, resulting in increased risk of fragility fractures and significant long-term disability. Although both anti-resorptive treatments and osteoanabolic drugs, such as parathyroid hormone analogues, are effective in fracture prevention, limitations exist due to lack of compliance or contraindications to these drugs. Thus, there is a need for novel potent therapies, especially for patients at high fracture risk. Romosozumab is a monoclonal antibody against sclerostin with a dual mode of action. It enhances bone formation and simultaneously suppresses bone resorption, resulting in a large anabolic window. In this opinion-based narrative review, we highlight the role of sclerostin as a critical regulator of bone mass and present human diseases of sclerostin deficiency as well as preclinical models of genetically modified sclerostin expression, which led to the development of anti-sclerostin antibodies. We review clinical studies of romosozumab in terms of bone mass accrual and anti-fracture activity in the setting of postmenopausal and male osteoporosis, present sequential treatment regimens, and discuss its safety profile and possible limitations in its use. Moreover, an outlook comprising future translational applications of anti-sclerostin antibodies in diseases other than osteoporosis is given, highlighting the clinical significance and future scopes of Wnt signaling in these settings.

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“…The second meta-analysis was a more thorough analysis of all medications used to treat osteoporosis and focused on effects on primary and secondary prevention. 19 The analysis concluded that romosozumab reduced the risk of vertebral (RR = 0.30; 95% CI = 0.23-0.41) and nonvertebral (HR = 0.69; 95% CI = 0.56-0.84) fractures compared with placebo in secondary fracture prevention. It also suggested that romosozumab was superior to alendronate, bazedoxifene, raloxifene, risedronate, and strontium in reduction of vertebral fractures and superior to bazedoxifene and raloxifene in reduction of nonvertebral fractures.…”

Section: Clinical Efficacymentioning

confidence: 99%

Romosozumab: A Novel Injectable Sclerostin Inhibitor With Anabolic and Antiresorptive Effects for Osteoporosis

Nealy

Harris

2020

Ann Pharmacother

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Objective: To review the clinical pharmacology, efficacy, and safety of romosozumab, a humanized monoclonal antibody with a novel mechanism of action for monthly injection, and its place in the management of osteoporosis. Data Sources: PubMed, MEDLINE, and ClinicalTrials.gov searches (1966 to July 2020) were conducted using the keywords romosozumab and osteoporosis. Study Selection and Data Extraction: Published phase 2 and 3 clinical trials and 2 meta-analyses in patients with osteoporosis were included. Data Synthesis: Romosozumab increased bone mineral density (BMD) at the lumbar spine (12.1%-13.3%), femoral neck (2.2%-5.9%), and total hip (2.5%-6.9%) in patients with osteoporosis. After 12 months, romosozumab provided greater BMD gains at the lumbar spine and hip than teriparatide. However, teriparatide is likely to further increase BMD if continued for up to 24 months. In postmenopausal women at a high fracture risk, 1 year of romosozumab followed by 1 year of alendronate resulted in lower vertebral, nonvertebral, clinical, and hip fractures than alendronate alone for 2 years. Although absolute event rates were low, serious cardiovascular and cerebrovascular events were numerically higher in 2 clinical trials when compared with alendronate (2.5% vs 1.9%, respectively) and placebo (4.9% vs 2.5%, respectively). Relevance to Patient Care and Clinical Practice: This review discusses the place in therapy for romosozumab in osteoporosis management as a novel agent. Conclusions: Romosozumab offers an alternative for patients with a high risk of osteoporotic fractures. Clinicians should avoid romosozumab in patients with a history of myocardial infarction or stroke in the past 12 months.

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Clinical efficacy and safety of drug interventions for primary and secondary prevention of osteoporotic fractures in postmenopausal women: Network meta-analysis followed by factor and cluster analysis

Cited by 15 publications

References 63 publications

Subsequent hip fractures in patients identified by a Fracture Liaison Service (FLS) in England and Wales – linkage of the national FLS and Hip Fracture databases

Subsequent hip fractures in patients identified by a Fracture Liaison Service (FLS) in England and Wales – linkage of the national FLS and Hip Fracture databases

Osteoporosis Treatment with Anti-Sclerostin Antibodies—Mechanisms of Action and Clinical Application

Romosozumab: A Novel Injectable Sclerostin Inhibitor With Anabolic and Antiresorptive Effects for Osteoporosis

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