Effectiveness of denosumab for fracture prevention in real-world postmenopausal women with osteoporosis: a retrospective cohort study

Wei

Pharmacoepidemiology and Drug

et al. 2023

Purpose To compile validation findings of diagnosis codes and related algorithms for health outcomes of interest from National Health Insurance (NHI) or electronic medical records in Taiwan. Methods We carried out a literature review of English articles in PubMed® and Embase from 2000 through July 2022 with appropriate search terms. Potentially relevant articles were identified through review of article titles and abstracts, full text search of methodology terms “validation”, “positive predictive value”, and “algorithm” in Subjects & Methods (or Methods) and Results sections of articles, followed by full text review of potentially eligible articles. Results We identified 50 published reports with validation findings of diagnosis codes and related algorithms for a wide range of health outcomes of interest in Taiwan, including cardiovascular diseases, stroke, renal impairment, malignancy, diabetes, mental health diseases, respiratory diseases, viral (B and C) hepatitis, and tuberculosis. Most of the reported PPVs were in the 80% ~ 99% range. Assessment of algorithms based on ICD‐10 systems were reported in 8 articles, all published in 2020 or later. Conclusions Investigators have published validation reports that may serve as empirical evidence to evaluate the utility of secondary health data environment in Taiwan for research and regulatory purpose.

Section: Discussionmentioning

confidence: 99%

Validation of diagnosis codes in healthcare databases in Taiwan, a literature review

Wei

Pharmacoepidemiology and Drug

et al. 2023

“…Osteoporosis is known to increase the risk of frequent junctional collapse or compression fractures following spinal surgery with instrumentation [32]. Denosumab was effective in maintaining skeletal BMD and preventing osteoporosis fractures in a real-world study [33,34]. However, patients who discontinue denosumab are at a greater risk for developing major osteoporotic fractures including multiple vertebral fractures [35].…”

Section: Discussionmentioning

confidence: 99%

Denosumab vs placebo efficacy in bone mineral density, bone turnover markers, and function in osteopenic patients with lumbar degenerative diseases after lumbar fusion surgery: a randomized controlled trial

Wang

Xiao

Wang

et al. 2023

Preprint

Objective: Denosumab has been shown to be effective in increasing bone mineral density (BMD) in postmenopausal women with osteoporosis. However, the effect of denosumab on BMD, bone turnover markers (BTMs), and quality of life in osteopenic patients after spinal fusion remains unknown. Methods: We performed a randomized, double blinded, placebo-controlled clinical trial in osteopenic patients with lumbar degenerative diseases. All participants underwent lumbar fusion, received calcium (1200 mg/day) and vitamin D (800 IU/day) supplementation, and were randomized to receive subcutaneous injection of 60 mg denosumab or placebo every 6 months post-surgery. Patients were followed for up to 12 months post-operation. Results: We found that denosumab significantly improved percentage BMD of lumbar spine by 5.35% vs -0.45%, total hip by 3.68% vs -0.72%, and femoral neck by 3.41% vs -0.69% compared with placebo, at 12-month timepoint (p<0.05). Denosumab significantly decreased percentage change of amino-terminal propeptide of type 1 procollagen P1NP and β-C-terminal telopeptide of type 1 collagen CTX compared with placebo in osteopenic patients after lumbar fusion at the 12-month follow-up (p<0.05). Denosumab improved the Visual Analogue Scale (VAS) back scores, though no significant difference in VAS leg score, the EuroQol Five-Dimension (EQ-5D) questionnaire, the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31), and the Roland-Morris Disability Functioning Questionnaire (RMDQ) compared with the placebo group at the 12-month follow-up. Lastly, no significant difference was observed for the rate of new fractures, re-operation, complications, and adverse events between denosumab and placebo groups at the 12-month follow-up. Conclusion: Ultimately, our data demonstrate that denosumab is effective in increasing BMD of lumbar spine, total hip and femoral neck, suppression of BTMs and maintaining functional status in osteopenic patients after lumbar fusion surgery.

“…To mitigate this concern, we calculated the CCI score within 1 year before the first hospitalization with a hip or vertebral fracture to adjust for the impact of the existing disease status. Furthermore, the confounding influence of relatively low prevalence (< 5%) of alcohol and smoking usage among older adults in Taiwan [ 31 ] may be minimized. The sensitivity analysis for unmeasured confounding, the E-value [ 32 ], was 1.73-1.76 which can reflect the stability of the results in this study.…”

Section: Discussionmentioning

confidence: 99%

“…The osteoporosis cohort included patients aged 65 years and older between 2009 and 2017 who were newly diagnosed with osteoporosis (ICD-9-CM: 733.0 and 733.1, ICD-10-CM: M80 and M81) at least twice in outpatient records. The fracture cohort comprised patients who were newly diagnosed with either a hip fracture (ICD-9-CM: 820 and 733.14, ICD-10-CM: S72) or a vertebral fracture (ICD-9-CM: 805.2-805.9 and 733.13, ICD-10-CM: S22.0, S22.1, and S32.0-S32.2) once in an inpatient record, the definition was based on the previous study on hip fracture using Taiwan’s NHI claims [ 31 , 34 ]. Participants who satisfied both cohorts were enrolled, and their death status was followed up until December 31, 2018.…”

Section: Methodsmentioning

confidence: 99%

The association between osteoporosis medications and lowered all-cause mortality after hip or vertebral fracture in older and oldest-old adults: a nationwide population-based study

Hsu

Liang

et al. 2022

Aging

Background: Osteoporotic fracture is a common public-health problem in ageing societies. Although postfracture usage of osteoporosis medications may reduce mortality, recent results have been inconsistent. We aimed to examine associations between osteoporosis medication and mortality in older adults, particularly oldest-old adults (>=85 years old). Methods: Participants aged 65 years old and older newly diagnosed with both osteoporosis and hip or vertebral fractures within 2009-2017 were recruited from the records of 23,455,164 people in Taiwan National Health Insurance Research Database (NHIRD). Osteoporosis medication exposure was calculated after the first-time ambulatory visit with newly diagnosed osteoporosis. Mortality and its specific causes were ascertained from Cause of Death Data. Patients were followed until death or censored at the end of 2018. Results: A total of 87,935 participants aged 65 years old and over (73.4% female), with a mean 4.13 follow-up years, were included. Taking medication was associated with significantly lower risk of mortality (hip fracture HR 0.75, vertebral fracture HR 0.74), even in the oldest-old adults (hip fracture HR 0.76, vertebral fracture HR 0.72), where a longer duration of taking osteoporosis medication was associated with lower all-cause mortality. Specific causes of mortality were also significantly lower for participants taking osteoporosis medication (cancer HR 0.84 in hip fracture, 0.75 in vertebral fracture; cardiovascular disease HR 0.85 in hip fracture, 0.91 in vertebral fracture). Conclusions: Osteoporosis medication after hip or vertebral fracture may reduce mortality risk in older adults, notably in oldest-old adults. Encouraging the use of post-fracture osteoporosis medication in healthcare policies is warranted.