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Association between vertebral fractures and comorbidities in patients with rheumatoid arthritis: a cross-sectional study.
IF 2.4 3区 医学 Q3 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-03-27 DOI: 10.1007/s00774-025-01597-9
Takeshi Mochizuki, Koichiro Yano, Naoko Otani, Ryo Hiroshima, Katsunori Ikari, Ken Okazaki

Introduction: Patients with rheumatoid arthritis (RA) are at an increased risk of osteoporosis and vertebral fractures. We investigated the risk factors for vertebral fractures and severe vertebral fractures in patients with RA, including comorbidities and urinary pentosidine levels.

Materials and methods: This study included 637 patients with available clinical data on urinary pentosidine levels, vertebral fractures, and comorbidities. Vertebral fractures were evaluated using plain X-ray imaging. Comorbidities considered relevant to osteoporosis were type 2 diabetes mellitus, chronic kidney disease, and lung diseases.

Results: The prevalence of vertebral fractures in this cohort was 30.1%. Patients with vertebral fracture Patients with vertebral fractures were significantly more likely to be older [odds ratio (OR) 1.075; 95% confidence interval (CI) 1.049-1.1.03], had higher prevalence of comorbidities (OR 1.770; 95% CI 1.138-2.753), higher urinary pentosidine levels (OR 1.028; 95% CI 1.013-1.044), higher history of non-vertebral fractures (OR 2.084; 95% CI 1.222-3.557), and lower total hip T-score (OR 0.526; 95% CI 0.329-0.841) than patients without vertebral fractures. Among patients with vertebral fractures, 54.2% had severe vertebral fractures. Patients with severe vertebral fractures were more likely to have lower lumbar spine T-scores (OR 0.768; 95% CI 0.622-0.949) than patients with non-severe vertebral fractures.

Conclusions: This study identified factors associated with vertebral fractures and severe vertebral fractures in patients with RA. Notably, vertebral fractures were associated with comorbidities and urinary pentosidine levels. In patients with RA and vertebral fractures, low BMD in the lumbar spine was a significant factor associated with severe vertebral fractures.

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引用次数: 0
Association of the weight-adjusted waist index with mortality in osteoporotic patients. 体重调整后腰围指数与骨质疏松症患者死亡率的关系。
IF 2.4 3区 医学 Q3 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-03-21 DOI: 10.1007/s00774-025-01594-y
Qian Lyu, Linxiao Ma, Huijie Liu, Haiyan Shao

Introduction: The prevalence of osteoporosis (OP) is steadily rising, leading to a higher risk of mortality. This study assessed the impact of the Weight-Adjusted Waist Index (WWI) on osteoporosis-related mortality.

Materials and methods: Data from NHANES 2005-2010, 2013-2014, and 2017-2018 were analyzed to evaluate the relationship between WWI and mortality in osteoporotic patients using weighted proportional hazards model and Kaplan-Meier survival analysis. A subgroup analysis was performed to ensure the stability of the findings.

Results: The study included 1324 participants. The findings indicated a positive correlation between WWI and OP (OR 1.65, 95% CI 1.45-1.89). Among patients with OP, WWI showed a positive association with all-cause mortality (HR 1.28, 95% CI 1.10-1.48). There was no observed correlation between varying WWI levels and mortality due to cardiovascular disease or cancer.

Conclusions: Maintaining a lower WWI is associated with a reduced risk of all-cause mortality among individuals with OP.

{"title":"Association of the weight-adjusted waist index with mortality in osteoporotic patients.","authors":"Qian Lyu, Linxiao Ma, Huijie Liu, Haiyan Shao","doi":"10.1007/s00774-025-01594-y","DOIUrl":"https://doi.org/10.1007/s00774-025-01594-y","url":null,"abstract":"<p><strong>Introduction: </strong>The prevalence of osteoporosis (OP) is steadily rising, leading to a higher risk of mortality. This study assessed the impact of the Weight-Adjusted Waist Index (WWI) on osteoporosis-related mortality.</p><p><strong>Materials and methods: </strong>Data from NHANES 2005-2010, 2013-2014, and 2017-2018 were analyzed to evaluate the relationship between WWI and mortality in osteoporotic patients using weighted proportional hazards model and Kaplan-Meier survival analysis. A subgroup analysis was performed to ensure the stability of the findings.</p><p><strong>Results: </strong>The study included 1324 participants. The findings indicated a positive correlation between WWI and OP (OR 1.65, 95% CI 1.45-1.89). Among patients with OP, WWI showed a positive association with all-cause mortality (HR 1.28, 95% CI 1.10-1.48). There was no observed correlation between varying WWI levels and mortality due to cardiovascular disease or cancer.</p><p><strong>Conclusions: </strong>Maintaining a lower WWI is associated with a reduced risk of all-cause mortality among individuals with OP.</p>","PeriodicalId":15116,"journal":{"name":"Journal of Bone and Mineral Metabolism","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143676962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Methodology for the international working group clinical practice guidelines on X-linked hypophosphatemia in children and adults.
IF 2.4 3区 医学 Q3 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-03-21 DOI: 10.1007/s00774-025-01585-z
Dalal S Ali, Aliya A Khan, Reza D Mirza, Natasha M Appelman-Dijkstra, Maria Luisa Brandi, Thomas O Carpenter, Catherine Chaussain, Erik A Imel, Suzanne M Jan de Beur, Pablo Florenzano, Archibald Morrison, Hajar Abu Alrob, R Todd Alexander, Farah Alsarraf, Signe Sparre Beck-Nielsen, Martin Biosse-Duplan, Martine Cohen-Solal, Rachel K Crowley, Karel Dandurand, Guido Filler, Seiji Fukumoto, Claudia Gagnon, Paul Goodyer, Corinna Grasemann, Chelsey Grimbly, Salma Hussein, Muhammad K Javaid, Sarah Khan, Aneal Khan, Anna Lehman, Willem F Lems, E Michael Lewiecki, Ciara McDonnell, Emmett Morgante, Anthony A Portale, Yumie Rhee, Heide Siggelkow, Laura Tosi, Leanne M Ward, Gordon Guyatt

The guideline panel, comprising international experts in X-linked hypophosphatemia (XLH), patient partners from the XLH patient population, and guideline methodologists, held 18 teleconferences between January 2023 and July 2024 to develop comprehensive guidelines for the diagnosis and management of XLH in children and adults. For a subset of our questions, we utilized the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology, assessed the certainty of evidence and formulated GRADEd recommendations. For these questions, the panelists and methodologists collaboratively framed PICO (Population, Intervention, Control, and Outcomes) questions and conducted four systematic reviews assessing the impact of medical therapy-using either burosumab or phosphate and active vitamin D-on patient-important outcomes in the XLH population as well as the impact of medical intervention compared to no treatment. We assessed the risk of bias and transparently generated summary of findings tables using MAGICApp. The panel developed three GRADEd treatment recommendations for adults and two for children. Each GRADEd recommendation was linked to an underlying body of evidence, reflecting judgments on the certainty of evidence, recommendation strength, values, preferences, and considerations of costs, feasibility, acceptability, and equity. Due to the paucity of evidence, the panel developed very low-quality GRADEd recommendations on monitoring patients with XLH based on an expert clinical practice survey. Using a rigorous narrative literature review, the panel developed non-GRADEd recommendations including guidance for pregnant women, patients with dental complications, and other areas where evidence is limited. This article summarizes the methodology utilized for the development of both GRADEd and non-GRADEd recommendations for patients with XLH.

{"title":"Methodology for the international working group clinical practice guidelines on X-linked hypophosphatemia in children and adults.","authors":"Dalal S Ali, Aliya A Khan, Reza D Mirza, Natasha M Appelman-Dijkstra, Maria Luisa Brandi, Thomas O Carpenter, Catherine Chaussain, Erik A Imel, Suzanne M Jan de Beur, Pablo Florenzano, Archibald Morrison, Hajar Abu Alrob, R Todd Alexander, Farah Alsarraf, Signe Sparre Beck-Nielsen, Martin Biosse-Duplan, Martine Cohen-Solal, Rachel K Crowley, Karel Dandurand, Guido Filler, Seiji Fukumoto, Claudia Gagnon, Paul Goodyer, Corinna Grasemann, Chelsey Grimbly, Salma Hussein, Muhammad K Javaid, Sarah Khan, Aneal Khan, Anna Lehman, Willem F Lems, E Michael Lewiecki, Ciara McDonnell, Emmett Morgante, Anthony A Portale, Yumie Rhee, Heide Siggelkow, Laura Tosi, Leanne M Ward, Gordon Guyatt","doi":"10.1007/s00774-025-01585-z","DOIUrl":"https://doi.org/10.1007/s00774-025-01585-z","url":null,"abstract":"<p><p>The guideline panel, comprising international experts in X-linked hypophosphatemia (XLH), patient partners from the XLH patient population, and guideline methodologists, held 18 teleconferences between January 2023 and July 2024 to develop comprehensive guidelines for the diagnosis and management of XLH in children and adults. For a subset of our questions, we utilized the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology, assessed the certainty of evidence and formulated GRADEd recommendations. For these questions, the panelists and methodologists collaboratively framed PICO (Population, Intervention, Control, and Outcomes) questions and conducted four systematic reviews assessing the impact of medical therapy-using either burosumab or phosphate and active vitamin D-on patient-important outcomes in the XLH population as well as the impact of medical intervention compared to no treatment. We assessed the risk of bias and transparently generated summary of findings tables using MAGICApp. The panel developed three GRADEd treatment recommendations for adults and two for children. Each GRADEd recommendation was linked to an underlying body of evidence, reflecting judgments on the certainty of evidence, recommendation strength, values, preferences, and considerations of costs, feasibility, acceptability, and equity. Due to the paucity of evidence, the panel developed very low-quality GRADEd recommendations on monitoring patients with XLH based on an expert clinical practice survey. Using a rigorous narrative literature review, the panel developed non-GRADEd recommendations including guidance for pregnant women, patients with dental complications, and other areas where evidence is limited. This article summarizes the methodology utilized for the development of both GRADEd and non-GRADEd recommendations for patients with XLH.</p>","PeriodicalId":15116,"journal":{"name":"Journal of Bone and Mineral Metabolism","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143676966","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Romosozumab and cardiovascular safety in Japan.
IF 2.4 3区 医学 Q3 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-03-09 DOI: 10.1007/s00774-025-01596-w
Yasuhiro Takeuchi
{"title":"Romosozumab and cardiovascular safety in Japan.","authors":"Yasuhiro Takeuchi","doi":"10.1007/s00774-025-01596-w","DOIUrl":"https://doi.org/10.1007/s00774-025-01596-w","url":null,"abstract":"","PeriodicalId":15116,"journal":{"name":"Journal of Bone and Mineral Metabolism","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143585821","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Quercetins efficacy on bone and inflammatory markers, body composition, and physical function in postmenopausal women.
IF 2.4 3区 医学 Q3 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-03-07 DOI: 10.1007/s00774-025-01592-0
Alyssa R Bailly, Garrett M Hester, Michaela G Alesi, Robert J Buresh, Yuri Feito, Christine M Mermier, Jeremy B Ducharme, Trisha A VanDusseldorp

Introduction: This study aimed to investigate the effects of quercetin (a plant-based flavonoid) supplementation over 90 days on prominent bone turnover markers (BTMs), inflammatory markers, bone mineral density (BMD), body composition, and physical function in postmenopausal women.

Materials and methods: Thirty-three healthy postmenopausal women were recruited to participate in a double-blind, placebo-controlled investigation. Participants were randomized into one of two supplement groups: (1) 500 mg of quercetin (QUE) once daily or (2) 500 mg of methylcellulose (placebo; PLB) once daily. Pre- and post-testing visits included assessments of BTMs (i.e., osteocalcin [OC], procollagen type I N-terminal propeptide [PINP], and type I collagen cross-linked C-terminal telopeptide [CTX]), inflammatory markers (i.e., interleukin [IL]-6, tumor necrosis factor-alpha [TNF-α], and C-reactive protein [CRP]), BMD measurements, body composition measurements, and physical function including timed up and go and handgrip strength.

Results: The QUE group increased OC (p = 0.016; d = 0.89), PINP (p = 0.030; d = 0.64), and CTX (p = 0.023; d = 0.91) levels and decreased IL-6 (p = 0.045; d = 0.73) and TNF-α (p = 0.021; d = 0.90) levels compared to PLB. CRP (p = 0.448; d = 0.34), body composition (p > 0.05), and physical function (p > 0.05) remained unchanged.

Conclusion: The results suggest that QUE may better assist in controlling a normal bone turnover cycle by mediating bone formation and decreasing pro-inflammatory cytokines. However, although within the accepted range, there was an increase in the bone resorption marker and therefore, it is unclear if QUE will protect against future bone loss. Nonetheless, additional research is necessary to evaluate the bone-conserving properties of QUE among postmenopausal women.

Clinical trail registration: The ClinicalTrials.gov ID number: NCT05371340.

{"title":"Quercetins efficacy on bone and inflammatory markers, body composition, and physical function in postmenopausal women.","authors":"Alyssa R Bailly, Garrett M Hester, Michaela G Alesi, Robert J Buresh, Yuri Feito, Christine M Mermier, Jeremy B Ducharme, Trisha A VanDusseldorp","doi":"10.1007/s00774-025-01592-0","DOIUrl":"https://doi.org/10.1007/s00774-025-01592-0","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to investigate the effects of quercetin (a plant-based flavonoid) supplementation over 90 days on prominent bone turnover markers (BTMs), inflammatory markers, bone mineral density (BMD), body composition, and physical function in postmenopausal women.</p><p><strong>Materials and methods: </strong>Thirty-three healthy postmenopausal women were recruited to participate in a double-blind, placebo-controlled investigation. Participants were randomized into one of two supplement groups: (1) 500 mg of quercetin (QUE) once daily or (2) 500 mg of methylcellulose (placebo; PLB) once daily. Pre- and post-testing visits included assessments of BTMs (i.e., osteocalcin [OC], procollagen type I N-terminal propeptide [PINP], and type I collagen cross-linked C-terminal telopeptide [CTX]), inflammatory markers (i.e., interleukin [IL]-6, tumor necrosis factor-alpha [TNF-α], and C-reactive protein [CRP]), BMD measurements, body composition measurements, and physical function including timed up and go and handgrip strength.</p><p><strong>Results: </strong>The QUE group increased OC (p = 0.016; d = 0.89), PINP (p = 0.030; d = 0.64), and CTX (p = 0.023; d = 0.91) levels and decreased IL-6 (p = 0.045; d = 0.73) and TNF-α (p = 0.021; d = 0.90) levels compared to PLB. CRP (p = 0.448; d = 0.34), body composition (p > 0.05), and physical function (p > 0.05) remained unchanged.</p><p><strong>Conclusion: </strong>The results suggest that QUE may better assist in controlling a normal bone turnover cycle by mediating bone formation and decreasing pro-inflammatory cytokines. However, although within the accepted range, there was an increase in the bone resorption marker and therefore, it is unclear if QUE will protect against future bone loss. Nonetheless, additional research is necessary to evaluate the bone-conserving properties of QUE among postmenopausal women.</p><p><strong>Clinical trail registration: </strong>The ClinicalTrials.gov ID number: NCT05371340.</p>","PeriodicalId":15116,"journal":{"name":"Journal of Bone and Mineral Metabolism","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143573075","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Associations between hormones, metabolic markers, and bone mass in perimenopausal and postmenopausal women.
IF 2.4 3区 医学 Q3 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-03-05 DOI: 10.1007/s00774-025-01595-x
Bingru Lu, Qunxiao Han, Shiyu Zhao, Shan Ding, Guolin Bao, Yiqing Liu

Introduction: To explore the associations between hormones, metabolic markers, and low bone mass in perimenopausal and postmenopausal women.

Materials and methods: A total of 198 women were enrolled in this study. The correlations between hormones, metabolic markers, and BMD were analyzed. Risk factors for bone loss were identified. Receiver operating characteristic (ROC) curves were used to display the predictive power of these risk factors.

Results: The years since menopause and the levels of glucose (GLU), follicle-stimulating hormone (FSH), and luteinizing hormone (LH) were inversely correlated with BMD, while estrogen and testosterone were positively correlated with BMD. Age (odds ratio [OR] 1.232; 95% confidence interval [CI] 1.106-1.372; p < 0.001), GLU (OR 1.848; 95% CI 1.116-3.059; p = 0.017), and FSH (OR 1.089; 95% CI 1.003-1.182; p = 0.042) were identified as risk factors for bone loss. Age (AUC = 0.884, 95% CI 0.833-0.935), FSH (AUC = 0.824, 95% CI 0.760-0.888), and GLU (AUC = 0.683, 95% CI 0.599-0.768) demonstrated significant discrimination capability for bone loss. The combined application of these factors resulted in a better prediction effect (AUC = 0.930, 95% CI 0.893-0.967).

Conclusions: Age, FSH, and GLU were found to be specific risk factors for bone loss. The utilization of these factors offers compelling predictive power for bone loss in perimenopausal and postmenopausal women.

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引用次数: 0
Misaligned cardiovascular safety warnings for romosozumab in Japan.
IF 2.4 3区 医学 Q3 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-02-24 DOI: 10.1007/s00774-025-01593-z
Hiroshi Kawaguchi
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引用次数: 0
Association between serum homocysteine concentration level and tooth loss: a cross-sectional study from NHANES 2003-2006.
IF 2.4 3区 医学 Q3 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-02-18 DOI: 10.1007/s00774-025-01588-w
Shiyi Luo, Zefei Liu, Xuanyan Gu, Wei Li, Ruofeng Jiao, Jiangling Sun, Shu Ma, Haijian Zhu, Zhu Chen, Jukun Song

Introduction: This cross-sectional study aimed to investigate the associations between serum homocysteine levels and missing teeth, as well as to explore the threshold effect of serum homocysteine levels on the number of missing teeth.

Materials and methods: This study involved 4746 participants (aged ≥ 40 years) from NHANES data 2003-2006. Negative binomial regression was used to assess the association between serum homocysteine levels and tooth loss. Non-linear and dose-response relationships were analyzed using smooth curve fitting and threshold effect analysis. In addition, we supplemented the relationship between serum homocysteine levels and tooth loss and conducted subgroup analysis to determine the impact of covariates on the relationship between serum homocysteine levels and tooth loss.

Results: In a fully adjusted negative binomial regression model, higher levels of serum Hcy concentration in the Q2-Q4(Q2: IRR = 1.46, 95%CI (1.67,1.79)); Q3: IRR = 1.42, 95%CI (1.36,1.48); Q4: IRR = 1.47,95%CI (1.01,1.78)) groups increased the likelihood of tooth loss compared with quartile Q1 (low level of serum homocysteine). Threshold effect analysis revealed that the log2-transformed Hcy infection point was at 2.95 μmol/L.

Conclusion: The likelihood of tooth loss increased by 47% for each unit increase in serum homocysteine level. There was a non-linear positive correlation between serum homocysteine and tooth loss, with a threshold effect of approximately log2(Hcy) = 2.95 μmol/L. This link emphasizes the importance of maintaining appropriate homocysteine levels to prevent oral health problems.

{"title":"Association between serum homocysteine concentration level and tooth loss: a cross-sectional study from NHANES 2003-2006.","authors":"Shiyi Luo, Zefei Liu, Xuanyan Gu, Wei Li, Ruofeng Jiao, Jiangling Sun, Shu Ma, Haijian Zhu, Zhu Chen, Jukun Song","doi":"10.1007/s00774-025-01588-w","DOIUrl":"https://doi.org/10.1007/s00774-025-01588-w","url":null,"abstract":"<p><strong>Introduction: </strong>This cross-sectional study aimed to investigate the associations between serum homocysteine levels and missing teeth, as well as to explore the threshold effect of serum homocysteine levels on the number of missing teeth.</p><p><strong>Materials and methods: </strong>This study involved 4746 participants (aged ≥ 40 years) from NHANES data 2003-2006. Negative binomial regression was used to assess the association between serum homocysteine levels and tooth loss. Non-linear and dose-response relationships were analyzed using smooth curve fitting and threshold effect analysis. In addition, we supplemented the relationship between serum homocysteine levels and tooth loss and conducted subgroup analysis to determine the impact of covariates on the relationship between serum homocysteine levels and tooth loss.</p><p><strong>Results: </strong>In a fully adjusted negative binomial regression model, higher levels of serum Hcy concentration in the Q2-Q4(Q2: IRR = 1.46, 95%CI (1.67,1.79)); Q3: IRR = 1.42, 95%CI (1.36,1.48); Q4: IRR = 1.47,95%CI (1.01,1.78)) groups increased the likelihood of tooth loss compared with quartile Q1 (low level of serum homocysteine). Threshold effect analysis revealed that the log2-transformed Hcy infection point was at 2.95 μmol/L.</p><p><strong>Conclusion: </strong>The likelihood of tooth loss increased by 47% for each unit increase in serum homocysteine level. There was a non-linear positive correlation between serum homocysteine and tooth loss, with a threshold effect of approximately log2(Hcy) = 2.95 μmol/L. This link emphasizes the importance of maintaining appropriate homocysteine levels to prevent oral health problems.</p>","PeriodicalId":15116,"journal":{"name":"Journal of Bone and Mineral Metabolism","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143449102","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Randomized crossover comparison of two teriparatide self-injection regimens for primary osteoporosis: Interim report (end of 52-week treatment) of the Japanese Osteoporosis Intervention Trial 06 (JOINT-06).
IF 2.4 3区 医学 Q3 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-02-18 DOI: 10.1007/s00774-025-01586-y
Satoshi Soen, Yukari Uemura, Shiro Tanaka, Yasuhiro Takeuchi, Naoto Endo, Junichi Takada, Satoshi Ikeda, Jun Iwamoto, Nobukazu Okimoto, Sakae Tanaka

Introduction: Patient satisfaction with two teriparatide (TPTD) self-injection regimens [once-daily (1/D)-TPTD and twice-weekly (2/W)-TPTD] was compared in a randomized crossover study involving patients with osteoporosis at high fracture risk.

Materials and methods: Questionnaires evaluated overall satisfaction, satisfaction with treatment effectiveness, satisfaction with utility of the self-injection device, and preference for a particular injection regimen after crossover. Quality of life (QOL), visual analogue scale pain scores, and bone mineral density (BMD) were also analyzed. Safety was evaluated based on the incidence and severity of adverse events (AEs).

Results: The 1/D-TPTD and 2/W-TPTD groups comprised 180 (mean age: 75.9 ± 7.3 years) and 178 (75.4 ± 6.9 years) patients, respectively. After 26 weeks of treatment, the injection regimens were switched and treatment continued for another 26 weeks. Significantly higher persistence was observed in the 1/D-TPTD to 2/W-TPTD group (p = 0.032). No significant between-group differences in overall satisfaction scores or satisfaction with treatment were observed. Satisfaction with the utility of the injection device was significantly higher with the 2/W-TPTD regimen (p < 0.05); this regimen was preferred by 69.4% of patients after crossover (p < 0.001). A significant increase in BMD from baseline was observed at the lumbar vertebrae in both groups and at the hip area in the 1/D-TPTD to 2/W-TPTD group at 52 weeks (p < 0.05). Significant improvement in the QOL score was observed in both groups (p < 0.05). No serious AEs were reported.

Conclusion: Continuation of this study will further clarify patient satisfaction, treatment effects, and tolerability.

{"title":"Randomized crossover comparison of two teriparatide self-injection regimens for primary osteoporosis: Interim report (end of 52-week treatment) of the Japanese Osteoporosis Intervention Trial 06 (JOINT-06).","authors":"Satoshi Soen, Yukari Uemura, Shiro Tanaka, Yasuhiro Takeuchi, Naoto Endo, Junichi Takada, Satoshi Ikeda, Jun Iwamoto, Nobukazu Okimoto, Sakae Tanaka","doi":"10.1007/s00774-025-01586-y","DOIUrl":"https://doi.org/10.1007/s00774-025-01586-y","url":null,"abstract":"<p><strong>Introduction: </strong>Patient satisfaction with two teriparatide (TPTD) self-injection regimens [once-daily (1/D)-TPTD and twice-weekly (2/W)-TPTD] was compared in a randomized crossover study involving patients with osteoporosis at high fracture risk.</p><p><strong>Materials and methods: </strong>Questionnaires evaluated overall satisfaction, satisfaction with treatment effectiveness, satisfaction with utility of the self-injection device, and preference for a particular injection regimen after crossover. Quality of life (QOL), visual analogue scale pain scores, and bone mineral density (BMD) were also analyzed. Safety was evaluated based on the incidence and severity of adverse events (AEs).</p><p><strong>Results: </strong>The 1/D-TPTD and 2/W-TPTD groups comprised 180 (mean age: 75.9 ± 7.3 years) and 178 (75.4 ± 6.9 years) patients, respectively. After 26 weeks of treatment, the injection regimens were switched and treatment continued for another 26 weeks. Significantly higher persistence was observed in the 1/D-TPTD to 2/W-TPTD group (p = 0.032). No significant between-group differences in overall satisfaction scores or satisfaction with treatment were observed. Satisfaction with the utility of the injection device was significantly higher with the 2/W-TPTD regimen (p < 0.05); this regimen was preferred by 69.4% of patients after crossover (p < 0.001). A significant increase in BMD from baseline was observed at the lumbar vertebrae in both groups and at the hip area in the 1/D-TPTD to 2/W-TPTD group at 52 weeks (p < 0.05). Significant improvement in the QOL score was observed in both groups (p < 0.05). No serious AEs were reported.</p><p><strong>Conclusion: </strong>Continuation of this study will further clarify patient satisfaction, treatment effects, and tolerability.</p>","PeriodicalId":15116,"journal":{"name":"Journal of Bone and Mineral Metabolism","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143449116","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Assessment of evidence for the off-label application of osteoanabolic drugs in fracture healing and spinal fusion.
IF 2.4 3区 医学 Q3 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-02-18 DOI: 10.1007/s00774-025-01589-9
Hiroshi Kawaguchi

Osteoanabolic drugs are sometimes prescribed off-label for "fracture healing and spinal fusion." This study examines the scientific validity of such practices by analyzing existing clinical reports. The purported bone union-promoting effect of teriparatide in fracture cases has been refuted in clinical trials. While teriparatide shows efficacy in accelerating spinal fusion after surgery for patients with osteoporosis, there is no scientific justification for its off-label use in patients without osteoporosis. For osteoporosis patients, no clear evidence suggests that teriparatide is superior to antiresorptive drugs, making the rationale for switching from antiresorptive drugs to teriparatide weak. The efficacy in postoperative spinal fusion may primarily be attributed to systemic improvements in bone quality and quantity, enhancing the mechanical engagement of implants. The clinical evidence for the off-label use of romosozumab, another osteoanabolic drug, in fracture healing and spinal fusion is insufficient to support its efficacy. In conclusion, osteoanabolic drugs, like antiresorptive drugs, primarily have systemic functions in osteoporosis patients, with limited evidence supporting their role in promoting localized bone formation in fractures or spinal fusions.

{"title":"Assessment of evidence for the off-label application of osteoanabolic drugs in fracture healing and spinal fusion.","authors":"Hiroshi Kawaguchi","doi":"10.1007/s00774-025-01589-9","DOIUrl":"https://doi.org/10.1007/s00774-025-01589-9","url":null,"abstract":"<p><p>Osteoanabolic drugs are sometimes prescribed off-label for \"fracture healing and spinal fusion.\" This study examines the scientific validity of such practices by analyzing existing clinical reports. The purported bone union-promoting effect of teriparatide in fracture cases has been refuted in clinical trials. While teriparatide shows efficacy in accelerating spinal fusion after surgery for patients with osteoporosis, there is no scientific justification for its off-label use in patients without osteoporosis. For osteoporosis patients, no clear evidence suggests that teriparatide is superior to antiresorptive drugs, making the rationale for switching from antiresorptive drugs to teriparatide weak. The efficacy in postoperative spinal fusion may primarily be attributed to systemic improvements in bone quality and quantity, enhancing the mechanical engagement of implants. The clinical evidence for the off-label use of romosozumab, another osteoanabolic drug, in fracture healing and spinal fusion is insufficient to support its efficacy. In conclusion, osteoanabolic drugs, like antiresorptive drugs, primarily have systemic functions in osteoporosis patients, with limited evidence supporting their role in promoting localized bone formation in fractures or spinal fusions.</p>","PeriodicalId":15116,"journal":{"name":"Journal of Bone and Mineral Metabolism","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440788","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Journal of Bone and Mineral Metabolism
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