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BMJ (Clinical Research Ed.) May 2023To review the comparative effectiveness of osteoporosis treatments, including the bone anabolic agents, abaloparatide and romosozumab, on reducing the risk of fractures... (Meta-Analysis)
Meta-Analysis
Fracture risk reduction and safety by osteoporosis treatment compared with placebo or active comparator in postmenopausal women: systematic review, network meta-analysis, and meta-regression analysis of randomised clinical trials.
OBJECTIVE
To review the comparative effectiveness of osteoporosis treatments, including the bone anabolic agents, abaloparatide and romosozumab, on reducing the risk of fractures in postmenopausal women, and to characterise the effect of antiosteoporosis drug treatments on the risk of fractures according to baseline risk factors.
DESIGN
Systematic review, network meta-analysis, and meta-regression analysis of randomised clinical trials.
DATA SOURCES
Medline, Embase, and Cochrane Library to identify randomised controlled trials published between 1 January 1996 and 24 November 2021 that examined the effect of bisphosphonates, denosumab, selective oestrogen receptor modulators, parathyroid hormone receptor agonists, and romosozumab compared with placebo or active comparator.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES
Randomised controlled trials that included non-Asian postmenopausal women with no restriction on age, when interventions looked at bone quality in a broad perspective. The primary outcome was clinical fractures. Secondary outcomes were vertebral, non-vertebral, hip, and major osteoporotic fractures, all cause mortality, adverse events, and serious cardiovascular adverse events.
RESULTS
The results were based on 69 trials (>80 000 patients). For clinical fractures, synthesis of the results showed a protective effect of bisphosphonates, parathyroid hormone receptor agonists, and romosozumab compared with placebo. Compared with parathyroid hormone receptor agonists, bisphosphonates were less effective in reducing clinical fractures (odds ratio 1.49, 95% confidence interval 1.12 to 2.00). Compared with parathyroid hormone receptor agonists and romosozumab, denosumab was less effective in reducing clinical fractures (odds ratio 1.85, 1.18 to 2.92 for denosumab parathyroid hormone receptor agonists and 1.56, 1.02 to 2.39 for denosumab romosozumab). An effect of all treatments on vertebral fractures compared with placebo was found. In the active treatment comparisons, denosumab, parathyroid hormone receptor agonists, and romosozumab were more effective than oral bisphosphonates in preventing vertebral fractures. The effect of all treatments was unaffected by baseline risk indicators, except for antiresorptive treatments that showed a greater reduction of clinical fractures compared with placebo with increasing mean age (number of studies=17; β=0.98, 95% confidence interval 0.96 to 0.99). No harm outcomes were seen. The certainty in the effect estimates was moderate to low for all individual outcomes, mainly because of limitations in reporting, nominally indicating a serious risk of bias and imprecision.
CONCLUSIONS
The evidence indicated a benefit of a range of treatments for osteoporosis in postmenopausal women for clinical and vertebral fractures. Bone anabolic treatments were more effective than bisphosphonates in the prevention of clinical and vertebral fractures, irrespective of baseline risk indicators. Hence this analysis provided no clinical evidence for restricting the use of anabolic treatment to patients with a very high risk of fractures.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42019128391.
Topics: Humans; Female; Bone Density Conservation Agents; Network Meta-Analysis; Postmenopause; Denosumab; Receptor, Parathyroid Hormone, Type 1; Osteoporosis; Osteoporotic Fractures; Diphosphonates; Spinal Fractures; Risk Reduction Behavior; Osteoporosis, Postmenopausal; Randomized Controlled Trials as Topic
PubMed: 37130601
DOI: 10.1136/bmj-2021-068033 -
World Neurosurgery May 2018Traumatic spinal injury (TSI) results from injury to bony, ligamentous, and/or neurologic structures of the spinal column and can cause significant morbidity and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Traumatic spinal injury (TSI) results from injury to bony, ligamentous, and/or neurologic structures of the spinal column and can cause significant morbidity and mortality. The global burden of TSI is poorly understood, so we performed a systematic review and meta-analysis to estimate the global volume of TSI.
METHODS
We performed a systematic review through PubMed, Embase, and Cochrane Databases on TSI studies reported from 2000 to 2016. Collected data were used to perform a meta-analysis to estimate the annual incidence of TSI across World Health Organization regions and World Bank income groups using random-effect models. Incorporating global population figures, the annual worldwide volume of TSI was estimated.
RESULTS
A total of 102 studies were included in the systematic review and 19 studies in the meta-analysis. The overall global incidence of TSI was 10.5 cases per 100,000 persons, resulting in an estimated 768,473 [95% confidence interval, 597,213-939,732] new cases of TSI annually worldwide. The incidence of TSI was higher in low- and middle-income countries (8.72 per 100,000 persons) compared with high-income countries (13.69 per 100,000 persons). Road traffic accidents, followed by falls, were the most common mechanism of TSI worldwide. Overall, 48.8% of patients with TSI required surgery.
CONCLUSIONS
TSI is a major source of morbidity and mortality throughout the world. Largely preventable mechanisms, including road traffic accidents and falls, are the main causes of TSI globally. Further investigation is needed to delineate local and regional TSI incidences and causes, especially in low- and middle-income countries.
Topics: Accidental Falls; Accidents, Traffic; Adult; Female; Global Health; Humans; Incidence; Income; Male; Middle Aged; Spinal Injuries; Young Adult
PubMed: 29454115
DOI: 10.1016/j.wneu.2018.02.033 -
The Journal of Surgical Research Aug 2022Multiple rib fractures and flail chest are common in trauma patients and may result in significant morbidity and mortality. While rib fractures have historically been... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Multiple rib fractures and flail chest are common in trauma patients and may result in significant morbidity and mortality. While rib fractures have historically been treated conservatively, there is increasing interest in the benefits of surgical fixation. However, strong evidence that supports surgical rib fixation and identifies the most appropriate patients for its application is currently sparse.
METHODS
A systematic review and meta-analysis following PRISMA guidelines was performed to identify all peer-reviewed papers that examined surgical compared to conservative management of rib fractures. We undertook a subgroup analysis to determine the specific effects of rib fracture type, age, the timing of fixation and study design on outcomes. The primary outcomes were the length of hospital and ICU stay, and secondary outcomes included mechanical ventilation time, rates of pneumonia, and mortality.
RESULTS
Our search identified 45 papers in the systematic review, and 40 were included in the meta-analysis. There was a statistical benefit of surgical fixation compared to conservative management of rib fractures for length of ICU stay, mechanical ventilation, mortality, pneumonia, and tracheostomy. The subgroup analysis identified surgical fixation was most favorable for patients with flail chest and those who underwent surgical fixation within 72 h. Patients over 60 y had a statistical benefit of conservative management on length of hospital stay and mechanical ventilation.
CONCLUSIONS
Surgical fixation of flail and multiple rib fractures is associated with a reduction in morbidity and mortality outcomes compared to conservative management. However, careful selection of patients is required for the appropriate application of surgical rib fixation.
Topics: Flail Chest; Fracture Fixation, Internal; Humans; Length of Stay; Pneumonia; Retrospective Studies; Rib Fractures; Ribs; Spinal Fractures
PubMed: 35390577
DOI: 10.1016/j.jss.2022.02.055 -
British Journal of Sports Medicine Dec 2013There is limited knowledge on epidemiological injury data in judo. (Review)
Review
BACKGROUND
There is limited knowledge on epidemiological injury data in judo.
OBJECTIVE
To systematically review scientific literature on the frequency and characteristics of injuries in judo.
METHODS
The available literature up to June 2013 was searched for prospective as well as retrospective studies on injuries in judo. Data extraction and presentation focused on the incidence rate, injury risk, types, location and causes of injuries.
RESULTS
During the Olympic Games in 2008 and 2012, an average injury risk of about 11-12% has been observed. Sprains, strains and contusions, usually of the knee, shoulder and fingers, were the most frequently reported injuries, whereas being thrown was the most common injury mechanism. Severe injuries were quite rare and usually affected the brain and spine, whereas chronic injuries typically affected the finger joints, lower back and ears. The most common types of injuries in young judo athletes were contusions/abrasions, fractures and sprains/strains. Sex-differences data on judo injuries were mostly inconsistent. Some studies suggested a relationship between nutrition, hydration and/or weight cycling and judo injuries. Also, psychological factors may increase the risk of judo injuries.
CONCLUSIONS
The present review provides the latest knowledge on the frequency and characteristics of injuries in judo. Comprehensive knowledge about the risk of injury during sport activity and related risk factors represents an essential basis to develop effective strategies for injury prevention. Thus, the introduction of an ongoing injury surveillance system in judo is of utmost importance.
Topics: Adolescent; Athletic Injuries; Child; Contusions; Craniocerebral Trauma; Epidemiologic Methods; Extremities; Female; Fractures, Bone; Humans; Joint Dislocations; Male; Martial Arts; Sex Distribution; Spinal Injuries; Sprains and Strains; Young Adult
PubMed: 24255909
DOI: 10.1136/bjsports-2013-092886 -
World Neurosurgery Oct 2023Traumatic spine injury (TSI) leads to significant morbidity and mortality in children. However, the global epidemiology of pediatric TSI is currently unknown. We... (Review)
Review
OBJECTIVE
Traumatic spine injury (TSI) leads to significant morbidity and mortality in children. However, the global epidemiology of pediatric TSI is currently unknown. We conducted a systematic review and meta-analysis to estimate the global incidence of pediatric TSI and the burden of cases.
METHODS
PubMed, Embase, and Scopus were searched for reports in June 2021 and updated in March 2023 with no restrictions on language or year of publication. A meta-analysis was conducted to estimate the global incidence of pediatric TSI and, subsequently, the number of cases of pediatric TSI worldwide and the proportion requiring spine surgery.
RESULTS
Of 6557 studies, 25 met the inclusion criteria. Road traffic accidents (64%) were responsible for most cases reported in the literature, followed by falls (18%). The global incidence of TSI in children aged ≤20 years was estimated to be 14.24 of 100,000 children, or 375,734 children, with an estimated 114,975 requiring spine surgery. Across the World Bank income classification groups, lower middle-income countries had the highest pediatric TSI case burden (186,886 cases, with 57,187 requiring spine surgery). Across the World Health Organization regions, countries in the Southeast Asia region had the largest number of projected cases at 88,566, with 27,101 requiring surgical management, followed closely by the African region, with 87,235 projected cases and 26,694 requiring surgical management.
CONCLUSIONS
Pediatric TSI represents a large healthcare burden globally. Interventions targeting both injury prevention and strengthening of neurosurgical capacity, especially in low resource settings, are needed to address this global health challenge.
PubMed: 37473863
DOI: 10.1016/j.wneu.2023.07.051 -
Calcified Tissue International Jun 2023To assess the effectiveness and safety of denosumab (Prolia®) compared to bisphosphonates (alendronate, ibandronate, risedronate, zoledronate), selective estrogen... (Meta-Analysis)
Meta-Analysis Review
The Clinical Effectiveness of Denosumab (Prolia®) for the Treatment of Osteoporosis in Postmenopausal Women, Compared to Bisphosphonates, Selective Estrogen Receptor Modulators (SERM), and Placebo: A Systematic Review and Network Meta-Analysis.
To assess the effectiveness and safety of denosumab (Prolia®) compared to bisphosphonates (alendronate, ibandronate, risedronate, zoledronate), selective estrogen receptor modulators (SERMs; bazedoxifene, raloxifene) or placebo, for the treatment of osteoporosis in postmenopausal women (PMW). Systematic searches were run in PubMed, Embase & Cochrane Library on 27-April-2022. Randomized controlled trials (RCTs) that included osteoporotic PMW allocated to denosumab, SERMs, bisphosphonates, or placebo were eligible for inclusion. RCTs were appraised using Cochrane Risk of Bias 2.0. Bayesian network and/or pairwise meta-analyses were conducted on predetermined outcomes (i.e. vertebral/nonvertebral fractures, bone mineral density [BMD], mortality, adverse events [AEs], serious AEs (SAEs), withdrawals due to AEs, AEs caused by denosumab discontinuation). A total of 12 RCTs (k = 22 publications; n = 25,879 participants) were included in the analyses. Denosumab, reported a statistically significant increase in lumbar spine (LS) and total hip (TH) BMD, compared to placebo. Similarly, denosumab also resulted in a statistically significant increase in TH BMD compared to the raloxifene and bazedoxifene. However, relative to denosumab, alendronate, ibandronate and risedronate resulted in significant improvements in both femoral neck (FN) and LS BMD. With regards to vertebral fractures and all safety outcomes, there were no statistically significant differences between denosumab and any of the comparator. Relative to placebo, denosumab was associated with significant benefits in both LS and TH BMD. Additionally, denosumab (compared to placebo) was not associated with reductions in vertebral and nonvertebral fractures. Finally, denosumab was not associated with improvement in safety outcomes, compared to placebo. These findings should be interpreted with caution as some analyses suffered from statistical imprecision.
Topics: Female; Humans; Diphosphonates; Selective Estrogen Receptor Modulators; Denosumab; Alendronate; Bone Density Conservation Agents; Risedronic Acid; Raloxifene Hydrochloride; Ibandronic Acid; Network Meta-Analysis; Postmenopause; Osteoporosis, Postmenopausal; Osteoporosis; Bone Density; Spinal Fractures; Treatment Outcome
PubMed: 37016189
DOI: 10.1007/s00223-023-01078-z -
The Cochrane Database of Systematic... Apr 2018Percutaneous vertebroplasty remains widely used to treat osteoporotic vertebral fractures although our 2015 Cochrane review did not support its role in routine practice. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Percutaneous vertebroplasty remains widely used to treat osteoporotic vertebral fractures although our 2015 Cochrane review did not support its role in routine practice.
OBJECTIVES
To update the available evidence of the benefits and harms of vertebroplasty for treatment of osteoporotic vertebral fractures.
SEARCH METHODS
We updated the search of CENTRAL, MEDLINE and Embase and trial registries to 15 November 2017.
SELECTION CRITERIA
We included randomised and quasi-randomised controlled trials (RCTs) of adults with painful osteoporotic vertebral fractures, comparing vertebroplasty with placebo (sham), usual care, or another intervention. As it is least prone to bias, vertebroplasty compared with placebo was the primary comparison. Major outcomes were mean overall pain, disability, disease-specific and overall health-related quality of life, patient-reported treatment success, new symptomatic vertebral fractures and number of other serious adverse events.
DATA COLLECTION AND ANALYSIS
We used standard methodologic procedures expected by Cochrane.
MAIN RESULTS
Twenty-one trials were included: five compared vertebroplasty with placebo (541 randomised participants), eight with usual care (1136 randomised participants), seven with kyphoplasty (968 randomised participants) and one compared vertebroplasty with facet joint glucocorticoid injection (217 randomised participants). Trial size varied from 46 to 404 participants, most participants were female, mean age ranged between 62.6 and 81 years, and mean symptom duration varied from a week to more than six months.Three placebo-controlled trials were at low risk of bias and two were possibly susceptible to performance and detection bias. Other trials were at risk of bias for several criteria, most notably due to lack of participant and personnel blinding.Compared with placebo, high- to moderate-quality evidence from five trials (one with incomplete data reported) indicates that vertebroplasty provides no clinically important benefits with respect to pain, disability, disease-specific or overall quality of life or treatment success at one month. Evidence for quality of life and treatment success was downgraded due to possible imprecision. Evidence was not downgraded for potential publication bias as only one placebo-controlled trial remains unreported. Mean pain (on a scale zero to 10, higher scores indicate more pain) was five points with placebo and 0.6 points better (0.2 better to 1 better) with vertebroplasty, an absolute pain reduction of 6% (2% better to 10% better, minimal clinical important difference is 15%) and relative reduction of 9% (3% better to14% better) (five trials, 535 participants). Mean disability measured by the Roland-Morris Disability Questionnaire (scale range zero to 23, higher scores indicate worse disability) was 14.2 points in the placebo group and 1.7 points better (0.3 better to 3.1 better) in the vertebroplasty group, absolute improvement 7% (1% to 14% better), relative improvement 10% better (3% to 18% better) (three trials, 296 participants).Disease-specific quality of life measured by the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) (scale zero to 100, higher scores indicating worse quality of life) was 62 points in the placebo group and 2.75 points (3.53 worse to 9.02 better) in the vertebroplasty group, absolute change: 3% better (4% worse to 9% better), relative change: 5% better (6% worse to 15% better (two trials, 175 participants). Overall quality of life (European Quality of Life (EQ5D), zero = death to 1 = perfect health, higher scores indicate greater quality of life) was 0.38 points in the placebo group and 0.05 points better (0.01 better to 0.09 better) in the vertebroplasty group, absolute improvement: 5% (1% to 9% better), relative improvement: 18% (4% to 32% better) (three trials, 285 participants). In one trial (78 participants), 9/40 (or 225 per 1000) people perceived that treatment was successful in the placebo group compared with 12/38 (or 315 per 1000; 95% CI 150 to 664) in the vertebroplasty group, RR 1.40 (95% CI 0.67 to 2.95), absolute difference: 9% more reported success (11% fewer to 29% more); relative change: 40% more reported success (33% fewer to 195% more).Moderate-quality evidence (low number of events) from seven trials (four placebo, three usual care, 1020 participants), up to 24 months follow-up, indicates we are uncertain whether vertebroplasty increases the risk of new symptomatic vertebral fractures (70/509 (or 130 per 1000; range 60 to 247) observed in the vertebroplasty group compared with 59/511 (120 per 1000) in the control group; RR 1.08 (95% CI 0.62 to 1.87)).Similarly, moderate-quality evidence (low number of events) from five trials (three placebo, two usual care, 821 participants), indicates uncertainty around the risk of other serious adverse events (18/408 or 76 per 1000, range 6 to 156) in the vertebroplasty group compared with 26/413 (or 106 per 1000) in the control group; RR 0.64 (95% CI 0.36 to 1.12). Notably, serious adverse events reported with vertebroplasty included osteomyelitis, cord compression, thecal sac injury and respiratory failure.Our subgroup analyses indicate that the effects did not differ according to duration of pain ≤ 6 weeks versus > 6 weeks. Including data from the eight trials that compared vertebroplasty with usual care in a sensitivity analyses altered the primary results, with all combined analyses displaying considerable heterogeneity.
AUTHORS' CONCLUSIONS
Based upon high- to moderate-quality evidence, our updated review does not support a role for vertebroplasty for treating acute or subacute osteoporotic vertebral fractures in routine practice. We found no demonstrable clinically important benefits compared with placebo (sham procedure) and subgroup analyses indicated that the results did not differ according to duration of pain ≤ 6 weeks versus > 6 weeks.Sensitivity analyses confirmed that open trials comparing vertebroplasty with usual care are likely to have overestimated any benefit of vertebroplasty. Correcting for these biases would likely drive any benefits observed with vertebroplasty towards the null, in keeping with findings from the placebo-controlled trials.Numerous serious adverse events have been observed following vertebroplasty. However due to the small number of events, we cannot be certain about whether or not vertebroplasty results in a clinically important increased risk of new symptomatic vertebral fractures and/or other serious adverse events. Patients should be informed about both the high- to moderate-quality evidence that shows no important benefit of vertebroplasty and its potential for harm.
Topics: Aged; Aged, 80 and over; Bone Cements; Female; Fractures, Compression; Glucocorticoids; Humans; Male; Middle Aged; Osteoporotic Fractures; Pain Measurement; Pain, Postoperative; Quality of Life; Randomized Controlled Trials as Topic; Spinal Fractures; Vertebroplasty
PubMed: 29618171
DOI: 10.1002/14651858.CD006349.pub3 -
Global Spine Journal May 2024Systematic Review and Meta-Analysis. (Review)
Review
STUDY DESIGN
Systematic Review and Meta-Analysis.
OBJECTIVE
Identify the incidence, mechanism of injury, investigations, management, and outcomes of Vertebral Artery Injury (VAI) after cervical spine trauma.
METHODS
A systematic review and meta-analysis were conducted in accordance with the PRISMA guidelines (PROSPERO-ID CRD42021295265). Three databases were searched (PubMed, SCOPUS, Google Scholar, CINAHL PLUS). Incidence of VAI, investigations to diagnose (Computed Tomography Angiography, Digital Subtraction Angiography, Magnetic Resonance Angiography), stroke incidence, and management paradigms (conservative, antiplatelets, anticoagulants, surgical, endovascular treatment) were delineated. Incidence was calculated using pooled proportions random effects meta-analysis.
RESULTS
A total of 44 studies were included (1777 patients). 20-studies (n = 503) included data on trauma type; 75.5% (n = 380) suffered blunt trauma and 24.5% (n = 123) penetrating. The overall incidence of VAI was .95% (95% CI 0.65-1.29). From the 16 studies which reported data on outcomes, 8.87% (95% CI 5.34- 12.99) of patients with VAI had a posterior stroke. Of the 33 studies with investigation data, 91.7% (2929/3629) underwent diagnostic CTA; 7.5% (242/3629) underwent MRA and 3.0% (98/3629) underwent DSA. Management data from 20 papers (n = 475) showed 17.9% (n = 85) undergoing conservative therapy, anticoagulation in 14.1% (n = 67), antiplatelets in 16.4% (n = 78), combined therapy in 25.5% (n = 121) and the rest (n = 124) managed using surgical and endovascular treatments.
CONCLUSION
VAI in cervical spine trauma has an approximate posterior circulation stroke risk of 9%. Optimal management paradigms for the prevention and management of VAI are yet to be standardized and require further research.
PubMed: 37924280
DOI: 10.1177/21925682231209631 -
BMJ (Clinical Research Ed.) Dec 2013To review the evidence on diagnostic accuracy of red flag signs and symptoms to screen for fracture or malignancy in patients presenting with low back pain to primary,... (Review)
Review
OBJECTIVE
To review the evidence on diagnostic accuracy of red flag signs and symptoms to screen for fracture or malignancy in patients presenting with low back pain to primary, secondary, or tertiary care.
DESIGN
Systematic review.
DATA SOURCES
Medline, OldMedline, Embase, and CINAHL from earliest available up to 1 October 2013.
INCLUSION CRITERIA
Primary diagnostic studies comparing red flags for fracture or malignancy to an acceptable reference standard, published in any language.
REVIEW METHODS
Assessment of study quality and extraction of data was conducted by three independent assessors. Diagnostic accuracy statistics and post-test probabilities were generated for each red flag.
RESULTS
We included 14 studies (eight from primary care, two from secondary care, four from tertiary care) evaluating 53 red flags; only five studies evaluated combinations of red flags. Pooling of data was not possible because of index test heterogeneity. Many red flags in current guidelines provide virtually no change in probability of fracture or malignancy or have untested diagnostic accuracy. The red flags with the highest post-test probability for detection of fracture were older age (9%, 95% confidence interval 3% to 25%), prolonged use of corticosteroid drugs (33%, 10% to 67%), severe trauma (11%, 8% to 16%), and presence of a contusion or abrasion (62%, 49% to 74%). Probability of spinal fracture was higher when multiple red flags were present (90%, 34% to 99%). The red flag with the highest post-test probability for detection of spinal malignancy was history of malignancy (33%, 22% to 46%).
CONCLUSIONS
While several red flags are endorsed in guidelines to screen for fracture or malignancy, only a small subset of these have evidence that they are indeed informative. These findings suggest a need for revision of many current guidelines.
Topics: Humans; Low Back Pain; Practice Guidelines as Topic; Spinal Fractures; Spinal Neoplasms
PubMed: 24335669
DOI: 10.1136/bmj.f7095 -
Journal of Bone and Mineral Research :... Apr 2019Meta-analyses conducted >15 years ago reported that improvements in bone mineral density (BMD) were associated with reduction in vertebral and nonvertebral fractures in... (Meta-Analysis)
Meta-Analysis
Meta-analyses conducted >15 years ago reported that improvements in bone mineral density (BMD) were associated with reduction in vertebral and nonvertebral fractures in osteoporosis trials. Numerous studies have been conducted since then, incorporating new therapies with different mechanisms of action and enrolling many more subjects. To extend these prior analyses, we conducted a meta-regression of 38 placebo-controlled trials of 19 therapeutic agents to determine the association between improvements in BMD and reductions in fracture risk. We used a linear model to examine the relationship between mean percent difference in BMD change between treatment and placebo groups and the logarithm of the relative risk. We found that greater improvements in BMD were strongly associated with greater reductions in vertebral and hip fractures but not nonvertebral fractures. For vertebral fracture, the r values for total hip, femoral neck, and lumbar spine BMD change were 0.56, 0.54, and 0.63, respectively (p ≤ 0.0002). For a 2% or 6% improvement in total hip BMD, we might expect a 28% or 66% reduction, respectively, in vertebral fracture risk. For hip fracture, the r values for total hip, femoral neck, and lumbar spine BMD change were 0.48 (p = 0.01), 0.42 (p = 0.02), and 0.22 (ns), respectively. For a 2% or 6% improvement in total hip BMD, we might expect a 16% or 40% reduction in hip fracture risk. In conclusion, our results extend prior observations that larger improvements in dual-energy X-ray absorptiometry (DXA)-based BMD are associated with greater reductions in fracture risk, particularly for vertebral and hip fractures. Although these results cannot be directly applied to predict the treatment benefit in an individual patient, they provide compelling evidence that improvements in BMD with osteoporosis therapies may be useful surrogate endpoints for fracture in trials of new therapeutic agents. © 2019 American Society for Bone and Mineral Research.
Topics: Absorptiometry, Photon; Bone Density; Hip Fractures; Humans; Osteoporosis; Osteoporotic Fractures; Randomized Controlled Trials as Topic; Risk Factors; Spinal Fractures
PubMed: 30674078
DOI: 10.1002/jbmr.3641