The Clinician’s Guide to Prevention and Treatment of Osteoporosis was developed by an expert committee of the National Osteoporosis Foundation (NOF) in collaboration with a multispecialty council of ...medical experts in the field of bone health convened by NOF. Readers are urged to consult current prescribing information on any drug, device, or procedure discussed in this publication.
Spine fracture prevalence is similar in men and women, increasing from <5% in those <60 to 11% in those 70–79 and 18% in those ≥80 years. Prevalence was higher with age, lower bone mineral density ...(BMD), and in those meeting criteria for spine imaging. Most subjects with spine fractures were unaware of them.
Summary Using national discharge and medical claims data, we studied the epidemiology of femoral fractures from 1996 to 2006. The annual hip fracture incidence declined from 600/100,000 to ...400/100,000, without decline in the more rare femur fractures. Incidence rates for subtrochanteric and femoral shaft fractures were each below 20 per 100,000. Introduction This study's purpose is to describe the site-specific epidemiology of femur fractures among people aged 50 and older. Methods Using the National Hospital Discharge Survey from 1996 to 2006 and a large medical claims database (MarketScan®), we studied epidemiology of all femur fractures. Hip fractures were grouped together; subtrochanteric, shaft, and distal femur fractures were kept separate. Results In females, the overall hospital discharge rates of hip fracture decreased from about 600/100,00 to 400/100,000 person-years from 1996 to 2006. Subtrochanteric, femoral shaft, and lower femur rates remained stable, each approximately 20 per 100,000 person-years. Similar trends but lower rates existed in males. No significant trends were found in any of these fractures during the more recent years of 2002-2006 (MarketScan data). Using MarketScan, the overall incidence of hip fracture was <300/100,000 person-years; incidence of subtrochanteric and femoral shaft fractures combined was <25/100,000 person-years and distal femur fracture incidence was <18/100,000 person-years in females; rates were lower in males. The incidence of hip and other femur fractures increased exponentially with age. Conclusions We found no evidence of an increasing incidence of any femoral fracture. Hip fracture incidence is declining but the incidence of each of the more rare femur fractures (distal to the lesser trochanter) is stable over time.
The surgeon general of the USA defines osteoporosis as “a skeletal disorder characterized by compromised bone strength, predisposing to an increased risk of fracture.” Measuring bone strength,
...Biomechanical Computed Tomography
analysis (BCT), namely, finite element analysis of a patient’s clinical-resolution computed tomography (CT) scan, is now available in the USA as a Medicare screening benefit for osteoporosis diagnostic testing. Helping to address under-diagnosis of osteoporosis, BCT can be applied “opportunistically” to most existing CT scans that include the spine or hip regions and were previously obtained for an unrelated medical indication. For the BCT test, no modifications are required to standard clinical CT imaging protocols. The analysis provides measurements of bone strength as well as a dual-energy X-ray absorptiometry (DXA)–equivalent bone mineral density (BMD) T-score at the hip and a volumetric BMD of trabecular bone at the spine. Based on both the bone strength and BMD measurements, a physician can identify osteoporosis and assess fracture risk (high, increased, not increased), without needing confirmation by DXA. To help introduce BCT to clinicians and health care professionals, we describe in this review the currently available clinical implementation of the test (VirtuOst), its application for managing patients, and the underlying supporting evidence; we also discuss its main limitations and how its results can be interpreted clinically. Together, this body of evidence supports BCT as an accurate and convenient diagnostic test for osteoporosis in both sexes, particularly when used opportunistically for patients already with CT.
Mini Abstract
Biomechanical Computed Tomography analysis (BCT) uses a patient’s CT scan to measure both bone strength and bone mineral density at the hip or spine. Performing at least as well as DXA for both diagnosing osteoporosis and assessing fracture risk, BCT is particularly well-suited to “opportunistic” use for the patient without a recent DXA who is undergoing or has previously undergone CT testing (including hip or spine regions) for an unrelated medical condition.
A single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis. We assessed the effects of annual infusions ...of zoledronic acid on fracture risk during a 3-year period.
In this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of zoledronic acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes.
Treatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the zoledronic-acid group vs. 10.9% in the placebo group; relative risk, 0.30; 95% confidence interval CI, 0.24 to 0.38) and reduced the risk of hip fracture by 41% (1.4% in the zoledronic-acid group vs. 2.5% in the placebo group; hazard ratio, 0.59; 95% CI, 0.42 to 0.83). Nonvertebral fractures, clinical fractures, and clinical vertebral fractures were reduced by 25%, 33%, and 77%, respectively (P<0.001 for all comparisons). Zoledronic acid was also associated with a significant improvement in bone mineral density and bone metabolism markers. Adverse events, including change in renal function, were similar in the two study groups. However, serious atrial fibrillation occurred more frequently in the zoledronic acid group (in 50 vs. 20 patients, P<0.001).
A once-yearly infusion of zoledronic acid during a 3-year period significantly reduced the risk of vertebral, hip, and other fractures. (ClinicalTrials.gov number, NCT00049829.)
Mini abstract
Real-world evidence on the comparative effectiveness and safety of abaloparatide versus teriparatide in women with osteoporosis may help inform treatment decisions. Following 18 months ...of treatment, abaloparatide was comparable to teriparatide for prevention of nonvertebral fractures, resulted in a 22% risk reduction for hip fractures, and demonstrated similar cardiovascular safety.
Summary
Osteoporotic fracture risk can be reduced with anabolic or antiresorptive medications. In addition to efficacy and safety data from controlled clinical trials, real-world evidence on comparative effectiveness and safety may help inform treatment decisions.
Introduction
The real-world effectiveness of abaloparatide versus teriparatide on nonvertebral fracture (NVF) incidence and cardiovascular safety during the 19-month period after treatment initiation were evaluated (NCT04974723).
Methods
Anonymized US patient claims data from Symphony Health, Integrated Dataverse (IDV)®, May 1, 2017 to July 31, 2019, included women aged ≥ 50 years with ≥ 1 prescription of abaloparatide or teriparatide and no prior anabolic therapy. Most were enrolled in commercial and Medicare health plans. Index was the date of the initial prescription dispensed during the identification period. In 1:1 propensity score matched cohorts, time to first NVF following index date, major adverse cardiovascular events (MACE), and MACE + heart failure (HF) were compared between cohorts using a Cox proportional hazards model.
Results
Propensity score matching yielded 11,616 patients per cohort. Overall median age (interquartile range) was 67 (61, 75) years, and 25.6% had a fracture history. Over 19 months, 335 patients on abaloparatide and 375 on teriparatide had a NVF (hazard ratio 95% confidence interval: 0.89 0.77, 1.03), and 121 and 154 patients, respectively, had a hip fracture HR (95% CI): 0.78 (0.62, 1.00). The MACE and MACE + HF rates were similar between cohorts.
Conclusions
Following 18 months of treatment, abaloparatide was comparable to teriparatide for prevention of NVF and similar cardiovascular safety was demonstrated between cohorts.
Summary
Post hoc analysis of FRAME and ARCH revealed that on-study nonvertebral and vertebral fractures by Month 12 were less common in women initially treated with romosozumab versus placebo or ...alendronate. Recurrent fracture risk was also lower in romosozumab‑treated patients, and there were no fracture‑related complications. Results support continuing romosozumab treatment post‑fracture.
Purpose
Post hoc analysis evaluating efficacy and safety of romosozumab, administered in the immediate post‑fracture period, in the FRAME and ARCH phase 3 trials.
Methods
In FRAME (NCT01575834) and ARCH (NCT01631214), postmenopausal women with osteoporosis were randomized 1:1 to romosozumab 210 mg monthly or comparator (FRAME, placebo; ARCH, alendronate 70 mg weekly) for 12 months, followed by antiresorptive therapy (FRAME, denosumab; ARCH, alendronate). In patients who experienced on-study nonvertebral or new/worsening vertebral fracture by Month 12, we report the following: fracture and treatment‑emergent adverse event (TEAE) incidence through 36 months, bone mineral density changes (BMD), and romosozumab timing. Due to the sample sizes employed, meaningful statistical comparisons between treatments were not possible.
Results
Incidence of on-study nonvertebral and vertebral fractures by Month 12 was numerically lower in romosozumab- versus comparator-treated patients (FRAME, 1.6% and 0.5% versus 2.1% and 1.6%; ARCH, 3.4% and 3.3% versus 4.6% and 4.9%, respectively). In those who experienced on-study nonvertebral fracture by Month 12, recurrent nonvertebral and subsequent vertebral fracture incidences were numerically lower in patients initially treated with romosozumab versus comparator (FRAME, 3.6% 2/56 and 1.8% 1/56 versus 9.2% 7/76 and 3.9% 3/76; ARCH, 10.0% 7/70 and 5.7% 4/70 versus 12.6% 12/95 and 8.4% 8/95, respectively). Among those with on-study vertebral fracture by Month 12, recurrent vertebral and subsequent nonvertebral fracture incidences were numerically lower with romosozumab versus comparator (FRAME, 0.0% 0/17 and 0.0% 0/17 versus 11.9% 7/59 and 8.5% 5/59; ARCH, 9.0% 6/67 and 7.5% 5/67 versus 15.0% 15/100 and 16.0% 16/100, respectively). In patients with fracture by Month 12, no fracture‑related complications were reported in romosozumab-treated patients. BMD gains were numerically greater with romosozumab than comparators.
Conclusion
Data suggest support for the efficacy and safety of continuing romosozumab treatment following fracture.
Trial registrations
NCT01575834; NCT01631214.
Summary
Spine fracture prevalence is similar in men and women, increasing from <5 % in those <60 to 11 % in those 70–79 and 18 % in those ≥80 years. Prevalence was higher with age, lower bone mineral ...density (BMD), and in those meeting criteria for spine imaging. Most subjects with spine fractures were unaware of them.
Introduction
Spine fractures have substantial medical significance but are seldom recognized. This study collected contemporary nationally representative spine fracture prevalence data.
Methods
Cross-sectional analysis of 3330 US adults aged ≥40 years participating in NHANES 2013–2014 with evaluable Vertebral Fracture Assessment (VFA). VFA was graded by semiquantitative measurement. BMD and an osteoporosis questionnaire were collected.
Results
Overall spine fracture prevalence was 5.4 % and similar in men and women. Prevalence increased with age from <5 % in those <60 to 11 % in those 70–79 and 18 % in those ≥80 years. Fractures were more common in non-Hispanic whites and in people with lower body mass index and BMD. Among subjects with spine fracture, 26 % met BMD criteria for osteoporosis. Prevalence was higher in subjects who met National Osteoporosis Foundation (NOF) criteria for spine imaging (14 vs 4.7 %,
P
< 0.001). Only 8 % of people with a spine fracture diagnosed by VFA had a self-reported fracture, and among those who self-reported a spine fracture, only 21 % were diagnosed with fracture by VFA.
Conclusion
Spine fracture prevalence is similar in women and men and increases with age and lower BMD, although most subjects with spine fracture do not meet BMD criteria for osteoporosis. Since most (>90 %) individuals were unaware of their spine fractures, lateral spine imaging is needed to identify these women and men. Spine fracture prevalence was threefold higher in individuals meeting NOF criteria for spine imaging (∼1 in 7 undergoing VFA). Identifying spine fractures as part of comprehensive risk assessment may improve clinical decision making.
PDF
