T-score as an Indicator of Fracture Risk on Therapy: Evidence From Romosozumab vs Alendronate Treatment in the ARCH Trial

Author(s):  
F Cosman ◽  
E. Michael Lewiecki ◽  
Peter R. Ebeling ◽  
E Hesse ◽  
N Napoli ◽  
...  
2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 294.2-294
Author(s):  
D. Ciardo ◽  
P. Pisani ◽  
F. A. Lombardi ◽  
R. Franchini ◽  
F. Conversano ◽  
...  

Background:The main consequence of osteoporosis is the occurrence of fractures due to bone fragility, with important sequelae in terms of disability and mortality. It has been already demonstrated that the information about bone mass density (BMD) alone is not sufficient to predict the risk of fragility fractures, since several fractures occur in patients with normal BMD [1].The Fragility Score is a parameter that allows to estimate skeletal fragility thanks to a trans-abdominal ultrasound scan performed with Radiofrequency Echographic Multi Spectrometry (REMS) technology. It is calculated by comparing the results of the spectral analysis of the patient’s raw ultrasound signals with reference models representative of fragile and non-fragile bones [2]. It is a dimensionless parameter, which can vary from 0 to 100, in proportion to the degree of fragility, independently from BMD.Objectives:This study aims to evaluate the effectiveness of Fragility Score, measured during a bone densitometry exam performed with REMS technology at lumbar spine, in identifying patients at risk of incident osteoporotic fractures at a follow-up period of 5 years.Methods:Caucasian women with age between 30 and 90 were scanned with spinal REMS and DXA. The incidence of osteoporotic fractures was assessed during a follow-up period of 5 years. The ability of the Fragility Score to discriminate between patients with and without incident fragility fractures was subsequently evaluated and compared with the discriminatory ability of the T-score calculated with DXA and with REMS.Results:Overall, 533 women (median age: 60 years; interquartile range [IQR]: 54-66 years) completed the follow-up (median 42 months; IQR: 35-56 months), during which 73 patients had sustained an incident fracture.Both median REMS and DXA measured T-score values were significantly lower in fractured patients than for non-fractured ones, conversely, REMS Fragility Score was significantly higher (Table 1).Table 1.Analysis of T-score values calculated with REMS and DXA and Fragility Score calculated with REMS. Median values and interquartile ranges (IQR) are reported. The p-value is derived from the Mann-Whitney test.Patients without incident fragility fracturePatients with incident fragility fracturep-valueT-score DXA[median (IQR)]-1.9 (-2.7 to -1.0)-2.6 (-3.3 to -1.7)0.0001T-score REMS[median (IQR)]-2.0 (-2.8 to -1.1)-2.7 (-3.5 to -1.9)<0.0001Fragility Score[median (IQR)]29.9 (25.7 to 36.2)53.0 (34.2 to 62.5)<0.0001By evaluating the capability to discriminate patients with/without fragility fractures, the Fragility Score obtained a value of the ROC area under the curve (AUC) of 0.80, higher than the AUC of the REMS T-score (0.66) and of the T-score DXA (0.64), and the difference was statistically significant (Figure 1).Figure 1.ROC curve comparison of Fragility Score, REMS and DXA T-score values in the classification of patients with incident fragility fractures.Furthermore, the correlation between the Fragility Score and the T-score values was low, with Pearson correlation coefficient r=-0.19 between Fragility Score and DXA T-score and -0.18 between the Fragility Score and the REMS T-score.Conclusion:The Fragility Score was found to be an effective tool for the prediction of fracture risk in a population of Caucasian women, with performances superior to those of the T-score values. Therefore, this tool presents a high potential as an effective diagnostic tool for the early identification and subsequent early treatment of bone fragility.References:[1]Diez Perez A et al. Aging Clin Exp Res 2019; 31(10):1375-1389.[2]Pisani P et al. Measurement 2017; 101:243–249.Disclosure of Interests:None declared


2017 ◽  
Vol 282 (6) ◽  
pp. 546-559 ◽  
Author(s):  
K. F. Axelsson ◽  
M. Wallander ◽  
H. Johansson ◽  
D. Lundh ◽  
M. Lorentzon

2019 ◽  
Vol 34 (6) ◽  
pp. 1033-1040 ◽  
Author(s):  
S Ferrari ◽  
C Libanati ◽  
Celia Jow Fang Lin ◽  
JP Brown ◽  
F Cosman ◽  
...  

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. e16023-e16023
Author(s):  
Marc Nicolas Bienz ◽  
Herbert James ◽  
Ilija Aleksic ◽  
Christopher Michael Pieczonka ◽  
Peter Iannotta ◽  
...  

2011 ◽  
Vol 14 (2) ◽  
pp. 162
Author(s):  
Jorge Ferreira ◽  
Ana Almeida ◽  
Anabela Almeida ◽  
Leonor Bastos ◽  
Marilia Bastos

2015 ◽  
Vol 7 (01) ◽  
pp. 043-048 ◽  
Author(s):  
Priyanka R Siddapur ◽  
Anuradha B Patil ◽  
Varsha S Borde

ABSTRACT Context: Postmenopausal osteoporosis is a public health problem. Diabetics are at increased risk of osteoporosis-related fractures. Zinc (Zn) has a role in collagen metabolism, and its levels are altered in diabetes. Aims: The aim was to compare bone mineral density (BMD), T-score and serum Zn between diabetic and nondiabetic postmenopausal women with osteoporosis to see if they influence increased fracture risk in diabetes. Settings and Design: It is a cross-sectional study conducted at Department of Biochemistry, Jawaharlal Nehru Medical College, Belgaum. Materials and Methods: Thirty type 2 diabetic and 30 age-matched (aged 45-75 years) nondiabetic Dual energy X-ray absorptiometry (DEXA) confirmed postmenopausal osteoporotics were included from January 2011 to March 2012. Serum Zn was analyzed by atomic absorption spectrophotometry. Statistical Analysis Used: Mean and standard deviation of the parameters of the two groups were computed and compared by unpaired Student's t-test. Relationship between variables was measured by Karl Pearson's correlation co-efficient. A statistical significance is set at 5% level of significance (P < 0.05). Results: T-score was significantly higher in diabetics compared with nondiabetics(−2.84 ± 0.42 vs. −3.22 ± 0.74) P < 0.05. BMD and serum Zn of diabetics showed a significant positive correlation with body mass index (BMI). Conclusions: Type 2 diabetic postmenopausal osteoporotics have a higher T-score than the nondiabetics. High BMI in type-2 diabetes mellitus (T2DM) may contribute to high BMD and may be a protective factor against zincuria. Increased fracture risk in T2DM could be due to other factors like poor bone quality due to hyperglycemia rather than BMD. Strict glycemic control is of paramount importance.


2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Crystal Sixian Liu ◽  
Lynn Feasel ◽  
Gregory A Kline ◽  
Emma O Billington

Abstract Osteoporosis affects &gt;200 million people, resulting in &gt;8.9 million annual fragility fractures worldwide. Available medications can reduce fracture risk by 40–60%, although access to specialty osteoporosis services is limited, and many individuals remain unaware of their fracture risk and their treatment options. As the one-on-one ‘traditional consultation’ (TC) model of osteoporosis care is not time efficient (i.e. a single TC often requires &gt;45 minutes), there is a need to identify innovative consultative models that can improve accessibility to osteoporosis care while maintaining quality. At our Osteoporosis Centre, we have implemented a group counseling model for this purpose: the Patient-Centred Educonsult Program for Osteoporosis (PEP-OP). Each two-hour PEP-OP session - co-facilitated by an osteoporosis physician and a nurse - provides up to 10 patients (the equivalent to 3–5 half-day physician clinics under the TC model) with a combined consultative and educational experience consisting of an individualized fracture risk assessment and extensive review of medications available to lower fracture risk. Patients are then encouraged to make an informed, autonomous decision about osteoporosis treatment initiation. Although the PEP-OP can accommodate a greater patient volume than the TC, and we have previously reported that the PEP-OP results in high patient satisfaction, it is not known whether PEP-OP produce similar results compared to TC in terms of treatment decisions. In this cohort study, we compared decisions to initiate osteoporosis therapy in PEP-OP (N=100) and TC (N=43) attendees. Ten-year risk of major osteoporotic fracture was estimated for each participant using the FRAX calculator, and participants were stratified based on whether their ten-year risk was ≥20% or &lt;20%. Proportion of participants in each risk category who decided to initiate treatment were compared between the PEP-OP and TC groups. PEP-OP and TC groups were comparable in terms of age (63.3 vs 64.9 years), BMI (24.4 vs 24.9 kg/m2), previous fragility fractures (35 vs 25%), parental hip fractures (19 vs 23%), lumbar neck T-score (-2.5 vs -2.3), femoral neck T-score (-2.1 vs -2.1) and average FRAX estimate (13.1 vs 13.3%). The proportion of participants at high ten-year risk of major osteoporotic fracture (≥20%) who decided to initiate treatment was similar in both the PEP-OP (7/16, 44%) and TC (5/10, 50%) groups, according to the Chi Square Test (p=0.76). Among those with FRAX estimate of &lt;20%, a similar proportion of patients in the PEP-OP (15/84, 18%) and TC (4/33, 12%) groups chose to undergo treatment (X2, p=0.45). In summary, decisions to initiate pharmacologic therapy were similar for the PEP-OP and the TC. Considering that the PEP-OP is acceptable to patients and is more efficient than the TC, this care model should be considered by other centers wishing to improve access to high-quality osteoporosis care.


2021 ◽  
Vol 67 (3) ◽  
pp. 322-327
Author(s):  
Ayça Utkan Karasu ◽  
Yetkin Karasu ◽  
Müzeyyen Gülnur Özakşit ◽  
Yusuf Üstün ◽  
Yaprak Üstün Engin

Objectives: This study aims to compare the fracture risk calculated with Fracture Risk Assessment Tool (FRAX®) in patients with natural and surgical menopause. Patients and methods: Between April 2019 and July 2019, 285 postmenopausal patients (mean age 57.3 years; range, 40 to 78 years) who were admitted to the menopause clinic were enrolled in this prospective cross-sectional study. Of these, 220 were in natural menopause and 65 were in surgical menopause. Demographic data, medical history, and International Physical Activity Questionnaire scores were collected through face-to-face interviews with the patients. Femoral neck and lumbar vertebrae (L1-L4) T-scores were evaluated using dual-energy X-ray absorptiometry. Fragility fracture risk was assessed using FRAX®. Results: The groups were similar in terms of age, body mass index, duration of menopause, smoking, alcohol use, and history of fracture (p>0.05). The risk of major osteoporotic fracture and hip fracture calculated without adding bone mineral density (BMD) was similar between groups (p=0.417 and p=0.234). The risk of hip fracture calculated with the addition of BMD was higher in natural menopause patients (p=0.023). Lumbar vertebrae T-scores were similar between two groups regardless of age; femoral neck T-scores were higher in surgical menopause (T-score=-0.8) than natural menopause group (T-score=-1.25) aged under 60 years, whereas this difference disappeared after 60 years of age. Conclusion: In our study, the fracture risk and the severity of osteoporosis were not different in surgical menopausal patients compared to the natural menopausal patients. Hip fracture risk calculated using BMD was lower in patients under 50 years of age in surgical menopausal patients. However, the fracture risks were similar in both groups after 50 years of age.


2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Raleigh A Fatoki ◽  
Bruce Ettinger ◽  
Malini Chandra ◽  
Kate M Horiuchi ◽  
Joan Chia-Mei Lo

Abstract BACKGROUND: Osteoporosis is traditionally associated with post-menopausal women, but up to up to one-third of osteoporosis-related fractures occur in elderly men. The International Society for Clinical Densitometry (ISCD), the World Health Organization, and the Fracture Risk Assessment Tool (FRAX) all recommend using a white female reference for BMD T-score for men. However, in clinical practice and previous clinical trials, a sex-specific white male reference T-score is used. This report examines the implications of using a female versus male reference for T-score calculation in men. METHODS: We reviewed BMD findings in 703 men (age 70-85y) who experienced a proximal femur, humerus, or distal radius/ulna fracture. For this cohort, femoral neck BMD was used to calculate a BMD T-score using either the young adult male and young adult female peak values (mean BMD 0.930 ± 0.136 and 0.849 ± 0.111 g/cm2, respectively). Osteoporosis was defined by BMD T-score ≤ -2.5, and osteopenia by BMD T-score &lt; -1.0 and &gt; -2.5. We also calculated FRAX-estimated fracture risk for hypothetical men ages 60-85y, with and without prior fracture. We used the National Osteoporosis Foundation (NOF) recommendations for treatment based on BMD (osteoporosis by BMD, or osteopenia by BMD with a 10-year risk of hip fracture ≥ 3% or 10-year risk of major osteoporotic fracture ≥ 20%). RESULTS: The mean BMD for this cohort was 0.670 g/cm2 and the median T scores were -2.0 (male reference) and -1.7 (female reference). Using the male T-score, 29% of men were classified as having osteoporosis, while using the female T-score, only 21% were so classified. 36% of men age 70-79y and 19% of men age 80-85y with osteoporosis (using the male T-score) would be reclassified from osteoporosis to osteopenia when a female T-score is used. Hypothetical cases of men age 60-85y (height 170 cm, weight 70 kg, BMD 0.590 g/cm2 equivalent to a male T -2.5 or female T -2.2) were used to calculate 10-year hip fracture risk using FRAX. For these hypothetical cases, the calculated 10-year risk of hip fracture exceeded the NOF treatment threshold of 3% (10-year hip fracture risk) for all cases, with or without prior fracture. CONCLUSION: For elderly men with fracture with male-T osteoporosis and female-T osteopenia, the T-score reference population used does not alter treatment recommendations because the calculated hip fracture risk is already above the treatment threshold of 3%. This is also true for men age ≥70 without a prior fracture. Hence the debate pertaining to the appropriate T-score reference population for men has limited relevance for men age ≥ 70 years who are being screened for osteoporosis.


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