Pub Date : 2025-06-01Epub Date: 2025-04-09DOI: 10.1007/s00198-025-07456-7
Heike A Bischoff-Ferrari, Bess Dawson-Hughes, John E Orav, Lisa Ceglia, Andreas Egli, Melanie Kistler-Fischbacher, Maud Wieczorek, Caroline de Godoi Rezende Costa Molino
Brief rationale: Limited evidence exists on calcifediol's effect on lower extremity function in postmenopausal women with osteoporosis or osteopenia.
Main result: Calcifediol (20 µg/day) showed no greater benefit than vitamin D3 (3200 IU/day) or placebo. Significance of the paper: Findings do not support high-dose vitamin D3 or calcifediol for improving lower extremity function.
Purpose: To test the effect of 20 µg/day of calcifediol compared with 3200 IU/day of vitamin D3 and placebo on lower extremity function in postmenopausal women with osteopenia or osteoporosis.
Methods: This is a 3-arm double-blind RCT among postmenopausal women aged 50-70 years with serum 25(OH)D < 30 ng/mL, and a DXA-based diagnosis of osteopenia or osteoporosis. Participants were randomized to receive either daily 20 µg calcifediol, daily 3200 IU vitamin D3, or placebo. The primary endpoint was a composite measure of lower extremity function, assessed at baseline, 3, and 6 months, including four tests: gait speed, knee flexor and extensor strength, and repeated sit-to-stand test. The primary endpoint was the probability of success (improvement or maintenance from baseline) in any of the eight tests, four tests at 3 months and four tests at 6 months.
Results: The trial enrolled 152 women (mean age, 61.0 years; mean serum 25(OH)D level, 23.4 ng/mL), and all but one woman completed all follow-up visits. Baseline characteristics, including the four tests of lower extremity function, were balanced across the three groups. The adjusted probability of success in any of the eight tests was 53.6% (95% confidence interval 47%, 60%) with calcifediol, 55.5% (50%, 61%) with vitamin D3, and 61.4% (55%, 67%) with placebo, without significant differences between treatment groups.
Conclusions: Our findings do not support supplementation with daily calcifediol or equivalent high-dose daily vitamin D3 for improving or maintaining lower extremity function among younger postmenopausal women (age 50-70) with osteopenia or osteoporosis, who were pre-selected for vitamin D insufficiency or deficiency (25(OH)D < 30 ng/mL; baseline mean 25(OH)D 23.4 ng/mL).
{"title":"Effect of calcifediol and cholecalciferol on muscle function in postmenopausal women: a randomized controlled trial.","authors":"Heike A Bischoff-Ferrari, Bess Dawson-Hughes, John E Orav, Lisa Ceglia, Andreas Egli, Melanie Kistler-Fischbacher, Maud Wieczorek, Caroline de Godoi Rezende Costa Molino","doi":"10.1007/s00198-025-07456-7","DOIUrl":"10.1007/s00198-025-07456-7","url":null,"abstract":"<p><p>Brief rationale: Limited evidence exists on calcifediol's effect on lower extremity function in postmenopausal women with osteoporosis or osteopenia.</p><p><strong>Main result: </strong>Calcifediol (20 µg/day) showed no greater benefit than vitamin D3 (3200 IU/day) or placebo. Significance of the paper: Findings do not support high-dose vitamin D3 or calcifediol for improving lower extremity function.</p><p><strong>Purpose: </strong>To test the effect of 20 µg/day of calcifediol compared with 3200 IU/day of vitamin D3 and placebo on lower extremity function in postmenopausal women with osteopenia or osteoporosis.</p><p><strong>Methods: </strong>This is a 3-arm double-blind RCT among postmenopausal women aged 50-70 years with serum 25(OH)D < 30 ng/mL, and a DXA-based diagnosis of osteopenia or osteoporosis. Participants were randomized to receive either daily 20 µg calcifediol, daily 3200 IU vitamin D3, or placebo. The primary endpoint was a composite measure of lower extremity function, assessed at baseline, 3, and 6 months, including four tests: gait speed, knee flexor and extensor strength, and repeated sit-to-stand test. The primary endpoint was the probability of success (improvement or maintenance from baseline) in any of the eight tests, four tests at 3 months and four tests at 6 months.</p><p><strong>Results: </strong>The trial enrolled 152 women (mean age, 61.0 years; mean serum 25(OH)D level, 23.4 ng/mL), and all but one woman completed all follow-up visits. Baseline characteristics, including the four tests of lower extremity function, were balanced across the three groups. The adjusted probability of success in any of the eight tests was 53.6% (95% confidence interval 47%, 60%) with calcifediol, 55.5% (50%, 61%) with vitamin D3, and 61.4% (55%, 67%) with placebo, without significant differences between treatment groups.</p><p><strong>Conclusions: </strong>Our findings do not support supplementation with daily calcifediol or equivalent high-dose daily vitamin D3 for improving or maintaining lower extremity function among younger postmenopausal women (age 50-70) with osteopenia or osteoporosis, who were pre-selected for vitamin D insufficiency or deficiency (25(OH)D < 30 ng/mL; baseline mean 25(OH)D 23.4 ng/mL).</p><p><strong>Trial registration: </strong>Clinicaltrials.gov; NCT02527668; https://clinicaltrials.gov/ct2/show/NCT02527668.</p>","PeriodicalId":19638,"journal":{"name":"Osteoporosis International","volume":" ","pages":"1007-1018"},"PeriodicalIF":4.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12122576/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144015092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01Epub Date: 2025-04-23DOI: 10.1007/s00198-024-07375-z
Marlene Chakhtoura, Elie Akl, Asma Arabi, Hala Ahmadieh, Stephanie Antoun, Paola Atallah, Rafic Baddoura, Maya Barake, Roger Bouillon, Peter Ebeling, Akram Echtay, Imad El-Kebbi, Marie Helene Ghannage-Yared, Georges Halaby, Nadine Hilal, Joanne Khabsa, Malek Nayfeh, Jad Okais, Mona Osman, Muheiddine Seoud, Imad Uthman, Ghada El-Hajj Fuleihan
Background: The Middle East and North Africa region are traditionally known as regions with a high prevalence of vitamin D deficiency. However, serum 25-hydroxyvitamin D (25OHD) levels seem to be increasing lately. We developed guidelines on the screening and supplementation of adult Lebanese patients with vitamin D. These guidelines address community-dwelling and institutionalized individuals.
Methods: Our guideline panel consisted of clinical and methodology experts that formulated the guidelines questions. We conducted a systematic review to gather global data on fracture (CRD42019129540), regional data on vitamin D trials (CRD42014010488), and on patients' values and preferences (CRD42022320022). We also complemented the latter with results from a cross-sectional local study. We followed the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to assess the quality and certainty of evidence, and to develop recommendations.
Results: For community-dwelling and institutionalized Lebanese adult population, the panel suggests no screening for vitamin D deficiency, over screening for vitamin D deficiency (conditional recommendation, based on very low certainty evidence). For community-dwelling Lebanese adult population, the panel suggests no supplementation with calcium and vitamin D, over supplementation (conditional recommendation, based on moderate certainty evidence). For institutionalized Lebanese adult population, the panel suggests supplementation with calcium and vitamin D, over no supplementation (conditional recommendation, based on moderate certainty evidence). The guidelines also identify high-risk subgroups, more likely to benefit from screening and supplementation. In community dwelling and institutionalized Lebanese adult individuals, for whom there is a decision to supplement with calcium and vitamin D, the panel suggests supplementation with a daily vitamin D equivalent of 600-2000 IU, as compared to doses higher than 2000 IU (conditional recommendation, very low certainty evidence).
Conclusion: The Lebanese GRADE-based vitamin D guidelines recommend against population screening and vitamin D supplementation. Subgroups at high risk are identified. The guidelines take into account contextual factors, and allow their adoption or adaptation in countries in the region.
{"title":"The Lebanese GRADE-based vitamin D guidelines: a paradigm for the MENA region.","authors":"Marlene Chakhtoura, Elie Akl, Asma Arabi, Hala Ahmadieh, Stephanie Antoun, Paola Atallah, Rafic Baddoura, Maya Barake, Roger Bouillon, Peter Ebeling, Akram Echtay, Imad El-Kebbi, Marie Helene Ghannage-Yared, Georges Halaby, Nadine Hilal, Joanne Khabsa, Malek Nayfeh, Jad Okais, Mona Osman, Muheiddine Seoud, Imad Uthman, Ghada El-Hajj Fuleihan","doi":"10.1007/s00198-024-07375-z","DOIUrl":"10.1007/s00198-024-07375-z","url":null,"abstract":"<p><strong>Background: </strong>The Middle East and North Africa region are traditionally known as regions with a high prevalence of vitamin D deficiency. However, serum 25-hydroxyvitamin D (25OHD) levels seem to be increasing lately. We developed guidelines on the screening and supplementation of adult Lebanese patients with vitamin D. These guidelines address community-dwelling and institutionalized individuals.</p><p><strong>Methods: </strong>Our guideline panel consisted of clinical and methodology experts that formulated the guidelines questions. We conducted a systematic review to gather global data on fracture (CRD42019129540), regional data on vitamin D trials (CRD42014010488), and on patients' values and preferences (CRD42022320022). We also complemented the latter with results from a cross-sectional local study. We followed the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to assess the quality and certainty of evidence, and to develop recommendations.</p><p><strong>Results: </strong>For community-dwelling and institutionalized Lebanese adult population, the panel suggests no screening for vitamin D deficiency, over screening for vitamin D deficiency (conditional recommendation, based on very low certainty evidence). For community-dwelling Lebanese adult population, the panel suggests no supplementation with calcium and vitamin D, over supplementation (conditional recommendation, based on moderate certainty evidence). For institutionalized Lebanese adult population, the panel suggests supplementation with calcium and vitamin D, over no supplementation (conditional recommendation, based on moderate certainty evidence). The guidelines also identify high-risk subgroups, more likely to benefit from screening and supplementation. In community dwelling and institutionalized Lebanese adult individuals, for whom there is a decision to supplement with calcium and vitamin D, the panel suggests supplementation with a daily vitamin D equivalent of 600-2000 IU, as compared to doses higher than 2000 IU (conditional recommendation, very low certainty evidence).</p><p><strong>Conclusion: </strong>The Lebanese GRADE-based vitamin D guidelines recommend against population screening and vitamin D supplementation. Subgroups at high risk are identified. The guidelines take into account contextual factors, and allow their adoption or adaptation in countries in the region.</p>","PeriodicalId":19638,"journal":{"name":"Osteoporosis International","volume":" ","pages":"937-950"},"PeriodicalIF":4.2,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144033912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-01Epub Date: 2025-03-20DOI: 10.1007/s00198-025-07453-w
Liza Sopina, Mette Friberg Hitz, Lau Caspar Thygesen, Bente Langdahl, Benedicte Torp Ladefoged, Marie Kruse
Osteoporosis significantly impacts healthcare costs in Denmark, with annual expenses exceeding €3097 per individual. The total annual burden of healthcare and productivity losses attributed to osteoporosis in Denmark surpasses €2 billion. Effective prevention, early detection, and management strategies should be considered to offset these costs and improve patient outcomes.
Purpose: As the prevalence of osteoporosis rises, driven by an ageing population, quantifying its financial impact and guiding resource allocation becomes crucial. The aim of this paper is to establish the healthcare (medical and social care) costs and productivity costs attributable to osteoporosis and osteoporosis-related fractures in Denmark.
Methods: The osteoporosis and osteoporosis fracture groups were identified from Danish healthcare registers using ICD-10 codes. The intervention group included individuals born in 1930-1950 with an osteoporosis diagnosis or an osteoporotic fracture with incidence between 2000 and 2021. A control group without osteoporosis and osteoporosis fractures was matched 1: 1 on a number of clinical and demographic variables from the general Danish population. Difference-in-difference approach was applied through generalised estimating equations with individual-level fixed effects to establish attributable costs.
Results: Osteoporosis and osteoporosis-related fractures can be attributed with more than €3097 annually in healthcare costs for individuals aged 50 to 91, with expenses increasing sharply with age. Cumulative attributable healthcare (medical and social care) cost of osteoporosis between the ages of 50 and 91 was estimated at reach €127,000 per person. For the identified population of over 667,000 people with osteoporosis, the total annual healthcare burden attributable to the disease would amount to over €2 billion. The osteoporosis group also incurred an annual productivity loss of €3883, until the age of 66.
Conclusion: Osteoporosis carries a pronounced economic burden for the health system and the individual. Resource allocative decisions should consider whether implementing strategies improving prevention, earlier detection, and better management of osteoporosis could be efficient given the high identified costs.
{"title":"Healthcare and productivity cost of osteoporosis: a Danish register-based quasi-experimental study.","authors":"Liza Sopina, Mette Friberg Hitz, Lau Caspar Thygesen, Bente Langdahl, Benedicte Torp Ladefoged, Marie Kruse","doi":"10.1007/s00198-025-07453-w","DOIUrl":"10.1007/s00198-025-07453-w","url":null,"abstract":"<p><p>Osteoporosis significantly impacts healthcare costs in Denmark, with annual expenses exceeding €3097 per individual. The total annual burden of healthcare and productivity losses attributed to osteoporosis in Denmark surpasses €2 billion. Effective prevention, early detection, and management strategies should be considered to offset these costs and improve patient outcomes.</p><p><strong>Purpose: </strong>As the prevalence of osteoporosis rises, driven by an ageing population, quantifying its financial impact and guiding resource allocation becomes crucial. The aim of this paper is to establish the healthcare (medical and social care) costs and productivity costs attributable to osteoporosis and osteoporosis-related fractures in Denmark.</p><p><strong>Methods: </strong>The osteoporosis and osteoporosis fracture groups were identified from Danish healthcare registers using ICD-10 codes. The intervention group included individuals born in 1930-1950 with an osteoporosis diagnosis or an osteoporotic fracture with incidence between 2000 and 2021. A control group without osteoporosis and osteoporosis fractures was matched 1: 1 on a number of clinical and demographic variables from the general Danish population. Difference-in-difference approach was applied through generalised estimating equations with individual-level fixed effects to establish attributable costs.</p><p><strong>Results: </strong>Osteoporosis and osteoporosis-related fractures can be attributed with more than €3097 annually in healthcare costs for individuals aged 50 to 91, with expenses increasing sharply with age. Cumulative attributable healthcare (medical and social care) cost of osteoporosis between the ages of 50 and 91 was estimated at reach €127,000 per person. For the identified population of over 667,000 people with osteoporosis, the total annual healthcare burden attributable to the disease would amount to over €2 billion. The osteoporosis group also incurred an annual productivity loss of €3883, until the age of 66.</p><p><strong>Conclusion: </strong>Osteoporosis carries a pronounced economic burden for the health system and the individual. Resource allocative decisions should consider whether implementing strategies improving prevention, earlier detection, and better management of osteoporosis could be efficient given the high identified costs.</p>","PeriodicalId":19638,"journal":{"name":"Osteoporosis International","volume":" ","pages":"865-874"},"PeriodicalIF":4.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12089169/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143669804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-01Epub Date: 2025-03-27DOI: 10.1007/s00198-025-07458-5
Anna Maria Markarian, Dennis R Taaffe, Francesco Bettariga, Hao Luo, Daniel A Galvão, Jodie Cochrane Wilkie, Carolyn J Peddle-McIntyre, Robert U Newton
Osteoporosis poses a significant concern for childhood cancer survivors (CCS). While recommendations for surveillance and management of bone mineral density (BMD) exist, no systematic review and meta-analysis has been undertaken to quantify BMD Z-scores in childhood cancer patients undergoing cancer treatment and survivors who have completed treatments. Accordingly, we conducted a systematic review with a 3-level mixed-effects meta-analysis to examine the course of BMD Z-scores in childhood cancer patients and survivors and identified possible moderators using meta-regression models. A systematic search was conducted in CINAHL, Embase, PubMed, SPORTDiscus, and Web of Science databases from inception to November 2023. We included studies that involved children and adolescents diagnosed with cancer before the age of 18 who were undergoing cancer treatment or had completed treatments and reported lumbar spine, hip/femoral neck, or total body BMD Z-scores derived from dual-energy x-ray absorptiometry. Forty-nine studies (4547 participants) were included in the meta-analysis. BMD Z-scores across different sites decreased with respect to baseline in children undergoing cancer treatment (mean difference: - 0.36, 95% CI - 0.62 to - 0.11; p = .01) and remained low following treatment in child and adolescent CCS (lumbar spine: - 0.85 SD, 95% CI - 1.17 to - 0.54; p < .001; hip/femoral neck: - 1.03 SD, 95% CI - 1.38 to - 0.68; p < .001), and adult CCS (lumbar spine: - 0.46 SD, 95% CI - 0.67 to - 0.26; p < .001; hip/femoral neck: - 0.36 SD, 95% CI - 0.57 to - 0.16; p < .001). Hip/femoral neck BMD Z-scores were moderated by age at assessment (p = .006), time from diagnosis (p = .004), sex (p = .037), and height (p = .026). Lumbar spine BMD Z-scores were moderated by age at assessment (p = .018), and sex (p = .015). In conclusion, childhood cancer patients and survivors experience reductions in BMD. Future research should evaluate the implications of regular physical activity, targeted exercise medicine, and nutrition therapy as first-line countermeasures to mitigate the declines in bone health.
骨质疏松症是儿童癌症幸存者(CCS)的一个重要问题。虽然存在监测和管理骨密度(BMD)的建议,但尚未进行系统评价和荟萃分析,以量化接受癌症治疗的儿童癌症患者和完成治疗的幸存者的BMD z评分。因此,我们进行了一项系统综述,采用三水平混合效应荟萃分析来检查儿童癌症患者和幸存者的BMD z -评分过程,并使用荟萃回归模型确定可能的调节因素。系统检索了CINAHL、Embase、PubMed、SPORTDiscus和Web of Science数据库,检索时间为2023年11月。我们纳入的研究涉及18岁前被诊断为癌症的儿童和青少年,他们正在接受癌症治疗或已完成治疗,并报告了腰椎、髋关节/股骨颈或由双能x线吸收仪得出的全身骨密度z评分。49项研究(4547名受试者)被纳入meta分析。在接受癌症治疗的儿童中,不同部位的BMD z分数相对于基线下降(平均差异:- 0.36,95% CI - 0.62至- 0.11;p = 0.01),并且在儿童和青少年CCS治疗后仍然很低(腰椎:- 0.85 SD, 95% CI - 1.17至- 0.54;p
{"title":"Bone mineral density in childhood cancer survivors during and after oncological treatment: A systematic review and meta-analysis.","authors":"Anna Maria Markarian, Dennis R Taaffe, Francesco Bettariga, Hao Luo, Daniel A Galvão, Jodie Cochrane Wilkie, Carolyn J Peddle-McIntyre, Robert U Newton","doi":"10.1007/s00198-025-07458-5","DOIUrl":"10.1007/s00198-025-07458-5","url":null,"abstract":"<p><p>Osteoporosis poses a significant concern for childhood cancer survivors (CCS). While recommendations for surveillance and management of bone mineral density (BMD) exist, no systematic review and meta-analysis has been undertaken to quantify BMD Z-scores in childhood cancer patients undergoing cancer treatment and survivors who have completed treatments. Accordingly, we conducted a systematic review with a 3-level mixed-effects meta-analysis to examine the course of BMD Z-scores in childhood cancer patients and survivors and identified possible moderators using meta-regression models. A systematic search was conducted in CINAHL, Embase, PubMed, SPORTDiscus, and Web of Science databases from inception to November 2023. We included studies that involved children and adolescents diagnosed with cancer before the age of 18 who were undergoing cancer treatment or had completed treatments and reported lumbar spine, hip/femoral neck, or total body BMD Z-scores derived from dual-energy x-ray absorptiometry. Forty-nine studies (4547 participants) were included in the meta-analysis. BMD Z-scores across different sites decreased with respect to baseline in children undergoing cancer treatment (mean difference: - 0.36, 95% CI - 0.62 to - 0.11; p = .01) and remained low following treatment in child and adolescent CCS (lumbar spine: - 0.85 SD, 95% CI - 1.17 to - 0.54; p < .001; hip/femoral neck: - 1.03 SD, 95% CI - 1.38 to - 0.68; p < .001), and adult CCS (lumbar spine: - 0.46 SD, 95% CI - 0.67 to - 0.26; p < .001; hip/femoral neck: - 0.36 SD, 95% CI - 0.57 to - 0.16; p < .001). Hip/femoral neck BMD Z-scores were moderated by age at assessment (p = .006), time from diagnosis (p = .004), sex (p = .037), and height (p = .026). Lumbar spine BMD Z-scores were moderated by age at assessment (p = .018), and sex (p = .015). In conclusion, childhood cancer patients and survivors experience reductions in BMD. Future research should evaluate the implications of regular physical activity, targeted exercise medicine, and nutrition therapy as first-line countermeasures to mitigate the declines in bone health.</p>","PeriodicalId":19638,"journal":{"name":"Osteoporosis International","volume":" ","pages":"767-777"},"PeriodicalIF":5.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12089199/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143720804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-01DOI: 10.1007/s00198-025-07452-x
Charlotte Beaudart, Nicola Veronese, Jonathan Douxfils, Jotheeswaran Amuthavalli Thiyagarajan, Francesco Bolzetta, Paolo Albanese, Gianpaolo Voltan, Majed Alokail, Nicholas C Harvey, Nicholas R Fuggle, Olivier Bruyère, René Rizzoli, Jean-Yves Reginster
{"title":"Correction: PTH1 receptor agonists for fracture risk: a systematic review and network meta-analysis.","authors":"Charlotte Beaudart, Nicola Veronese, Jonathan Douxfils, Jotheeswaran Amuthavalli Thiyagarajan, Francesco Bolzetta, Paolo Albanese, Gianpaolo Voltan, Majed Alokail, Nicholas C Harvey, Nicholas R Fuggle, Olivier Bruyère, René Rizzoli, Jean-Yves Reginster","doi":"10.1007/s00198-025-07452-x","DOIUrl":"10.1007/s00198-025-07452-x","url":null,"abstract":"","PeriodicalId":19638,"journal":{"name":"Osteoporosis International","volume":" ","pages":"935-936"},"PeriodicalIF":4.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12089191/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143731038","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The FEMuR III economic evaluation presents costs and consequences of the intervention compared with usual care at 52-week follow-up. There was no evidence of clinical effectiveness in terms of improvement of quality of life, and the total health service costs were higher in the intervention group.
Purpose: To explore the costs and consequences of the new FEMuR III intervention compared to usual care after hip fractures.
Methods: This cost-consequence analysis accompanies the FEMuR III randomised controlled trial using a micro-costing approach. The main outcome measures in this economic evaluation were healthcare service use, costs, and quality of life over 12 months, from both National Health Service and wider societal perspectives. Quality of life was measured using the EuroQoL-5D-3L.
Results: The mean cost of delivering the intervention was £444 per participant. For participants with complete EQ-5D data (n = 142), both groups showed improvement in EQ-5D index score, moving scores closer to UK norms. Participants in the intervention group gained 0.02 (95% CI: - 0.036, 0.076) more quality-adjusted life years (QALYs) than the usual care group. However, this was not statistically significant (p value = 0.312). For imputed cases, participants in the intervention group gained less QALYs than the usual care by 0.01 (95% CI: - 0.056, 0.030). For participants with complete cost data (n = 115), at 52-week follow-up, mean health service use costs were higher in the intervention group from both perspectives.
Conclusions: The mean health service use costs were higher in the intervention group due to longer inpatient stays. There was no significant difference in QALYs between both groups. The trial was affected by the COVID-19 pandemic, and this goes some way to explaining the large proportion of missing data (40%).
{"title":"A cost-consequence analysis of a community-based rehabilitation programme following hip fracture (Fracture in the Elderly Multidisciplinary Rehabilitation-FEMuR III).","authors":"Kodchawan Doungsong, Jacob Davies, Victory Ezeofor, Llinos Haf Spencer, Nefyn Williams, Rhiannon Tudor Edwards","doi":"10.1007/s00198-025-07459-4","DOIUrl":"10.1007/s00198-025-07459-4","url":null,"abstract":"<p><p>The FEMuR III economic evaluation presents costs and consequences of the intervention compared with usual care at 52-week follow-up. There was no evidence of clinical effectiveness in terms of improvement of quality of life, and the total health service costs were higher in the intervention group.</p><p><strong>Purpose: </strong>To explore the costs and consequences of the new FEMuR III intervention compared to usual care after hip fractures.</p><p><strong>Methods: </strong>This cost-consequence analysis accompanies the FEMuR III randomised controlled trial using a micro-costing approach. The main outcome measures in this economic evaluation were healthcare service use, costs, and quality of life over 12 months, from both National Health Service and wider societal perspectives. Quality of life was measured using the EuroQoL-5D-3L.</p><p><strong>Results: </strong>The mean cost of delivering the intervention was £444 per participant. For participants with complete EQ-5D data (n = 142), both groups showed improvement in EQ-5D index score, moving scores closer to UK norms. Participants in the intervention group gained 0.02 (95% CI: - 0.036, 0.076) more quality-adjusted life years (QALYs) than the usual care group. However, this was not statistically significant (p value = 0.312). For imputed cases, participants in the intervention group gained less QALYs than the usual care by 0.01 (95% CI: - 0.056, 0.030). For participants with complete cost data (n = 115), at 52-week follow-up, mean health service use costs were higher in the intervention group from both perspectives.</p><p><strong>Conclusions: </strong>The mean health service use costs were higher in the intervention group due to longer inpatient stays. There was no significant difference in QALYs between both groups. The trial was affected by the COVID-19 pandemic, and this goes some way to explaining the large proportion of missing data (40%).</p><p><strong>Trial registration: </strong>ISRCTN28376407.</p>","PeriodicalId":19638,"journal":{"name":"Osteoporosis International","volume":" ","pages":"883-892"},"PeriodicalIF":4.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12089205/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143731035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-01Epub Date: 2025-03-18DOI: 10.1007/s00198-025-07449-6
Jin-Ho Park, Ohsang Kwon, Jae Heouk Choi, Jin S Yeom, Sang-Min Park, Cheol Hyun Kim, Ho-Joong Kim
We conducted a randomized controlled trial to assess the preventive effect of perioperative teriparatide on proximal junctional kyphosis and proximal junctional failure (PJF) in osteoporosis patients undergoing adult spinal deformity surgery. Teriparatide (experimental group) and denosumab (active control) were administered. The teriparatide group demonstrated significantly better PJF incidence and VAS for back pain, EQ-5D than the control group.
Purpose: This randomized controlled trial is aimed at investigating and comparing the effects of perioperative teriparatide and denosumab as an active control for preventing proximal junctional kyphosis (PJK) and proximal junctional failure (PJF) in patients with osteoporosis after adult spinal deformity (ASD) surgery.
Methods: A total of 64 patients with osteoporosis, who planned to undergo ASD surgery, were randomly assigned to the teriparatide and denosumab groups. Treatment with teriparatide or denosumab in both groups was conducted from 3 months preoperatively to 3 months postoperatively based on the standard regimen for each medication. The primary outcome was PJK and PJF incidence within 1 year after ASD surgery. The secondary outcomes were patient-reported outcomes (PROs), bone mineral density (BMD), and dual-energy X-ray absorptiometry (DEXA) t-score of the hip.
Results: The teriparatide group showed a lower incidence of PJK than the denosumab group (17.2% vs. 33.3%), although this difference was not statistically significant (p = 0.165 in a modified intention-to-treat (mITT) analysis). Furthermore, the teriparatide group exhibited a significantly lower incidence of PJF than the denosumab group (3.4% vs. 22.2%; p = 0.034 in the mITT analysis). As for the secondary outcomes, no significant differences in BMD of the hip were observed between the two groups at the 1-year follow-up. The teriparatide group showed significantly improved postoperative VAS for back pain and EQ-5D score.
Conclusions: Perioperative teriparatide treatment of patients with osteoporosis after ASD surgery effectively reduced PJF incidence and postoperative back pain.
我们进行了一项随机对照试验,以评估围手术期特立帕肽对骨质疏松症患者接受成人脊柱畸形手术后近端关节后凸和近端关节功能衰竭(PJF)的预防作用。给予特立帕肽(实验组)和地诺单抗(主动对照组)。特立帕肽组PJF发生率和VAS对背痛、EQ-5D的评分均明显优于对照组。目的:本随机对照试验旨在调查和比较特立帕肽和地诺单抗作为预防成人脊柱畸形(ASD)手术后骨质疏松患者近端关节后凸(PJK)和近端关节功能衰竭(PJF)的围手术期有效对照的效果。方法:将64例拟行ASD手术的骨质疏松患者随机分为特立帕肽组和地诺单抗组。术前3个月至术后3个月,两组患者均采用特立帕肽或地诺单抗治疗。主要观察指标为ASD术后1年内PJK和PJF的发生率。次要结果是患者报告的结果(PROs)、骨密度(BMD)和髋关节双能x线吸收仪(DEXA) t评分。结果:特立帕肽组的PJK发生率低于地诺单抗组(17.2% vs 33.3%),尽管这一差异无统计学意义(修改意向治疗(mITT)分析p = 0.165)。此外,特立帕肽组PJF的发生率显著低于地诺单抗组(3.4% vs 22.2%;在mITT分析中p = 0.034)。次要结局方面,随访1年时,两组患者髋关节骨密度无显著差异。特立帕肽组术后腰痛VAS评分和EQ-5D评分明显改善。结论:特立帕肽围手术期治疗ASD术后骨质疏松患者可有效降低PJF的发生率和术后背部疼痛。
{"title":"Perioperative teriparatide for preventing proximal junctional kyphosis and failure in patients with osteoporosis after adult thoracolumbar spinal deformity surgery: a prospective randomized controlled trial.","authors":"Jin-Ho Park, Ohsang Kwon, Jae Heouk Choi, Jin S Yeom, Sang-Min Park, Cheol Hyun Kim, Ho-Joong Kim","doi":"10.1007/s00198-025-07449-6","DOIUrl":"10.1007/s00198-025-07449-6","url":null,"abstract":"<p><p>We conducted a randomized controlled trial to assess the preventive effect of perioperative teriparatide on proximal junctional kyphosis and proximal junctional failure (PJF) in osteoporosis patients undergoing adult spinal deformity surgery. Teriparatide (experimental group) and denosumab (active control) were administered. The teriparatide group demonstrated significantly better PJF incidence and VAS for back pain, EQ-5D than the control group.</p><p><strong>Purpose: </strong>This randomized controlled trial is aimed at investigating and comparing the effects of perioperative teriparatide and denosumab as an active control for preventing proximal junctional kyphosis (PJK) and proximal junctional failure (PJF) in patients with osteoporosis after adult spinal deformity (ASD) surgery.</p><p><strong>Methods: </strong>A total of 64 patients with osteoporosis, who planned to undergo ASD surgery, were randomly assigned to the teriparatide and denosumab groups. Treatment with teriparatide or denosumab in both groups was conducted from 3 months preoperatively to 3 months postoperatively based on the standard regimen for each medication. The primary outcome was PJK and PJF incidence within 1 year after ASD surgery. The secondary outcomes were patient-reported outcomes (PROs), bone mineral density (BMD), and dual-energy X-ray absorptiometry (DEXA) t-score of the hip.</p><p><strong>Results: </strong>The teriparatide group showed a lower incidence of PJK than the denosumab group (17.2% vs. 33.3%), although this difference was not statistically significant (p = 0.165 in a modified intention-to-treat (mITT) analysis). Furthermore, the teriparatide group exhibited a significantly lower incidence of PJF than the denosumab group (3.4% vs. 22.2%; p = 0.034 in the mITT analysis). As for the secondary outcomes, no significant differences in BMD of the hip were observed between the two groups at the 1-year follow-up. The teriparatide group showed significantly improved postoperative VAS for back pain and EQ-5D score.</p><p><strong>Conclusions: </strong>Perioperative teriparatide treatment of patients with osteoporosis after ASD surgery effectively reduced PJF incidence and postoperative back pain.</p>","PeriodicalId":19638,"journal":{"name":"Osteoporosis International","volume":" ","pages":"833-843"},"PeriodicalIF":4.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12089185/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143658009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-01Epub Date: 2025-03-20DOI: 10.1007/s00198-025-07412-5
Paul Gerdhem, Axel Wihlborg, Ingrid B Bergström
Brief rationale: To assess bone dimensions in the radius over 7 years.
Main result: Cross-sectional area did not change significantly, but endosteal circumference increased, leading to decreased cortical thickness. Significance of the paper: Bone mineral density loss is associated with a decrease in cortical thickness in the forearm.
Purpose: To assess site-specific volumetric bone and muscle differences in women with and without forearm fracture in a longitudinal study.
Methods: One hundred four postmenopausal women with a forearm fracture and 99 age-matched controls were included and underwent peripheral quantitative computed tomography (pQCT) in the forearm at a mean age of 65 (range 44-88) years and were invited for a reassessment after mean 7 (6-11) years, at which 80 and 79 women took part, respectively. Three cases had movement artifacts on pQCT; 77 cases and 79 controls were finally analysed.
Results: Twenty-two of the cases and 20 of the controls sustained a fracture during the follow-up. From baseline to follow-up, bone mineral content and bone mineral density decreased irrespective of group belonging at baseline, both at the 4% and the 66% level in the forearm. Cross-sectional area did not change significantly at the 4% and the 66% level. At the 66% level, periosteal circumference was unchanged and endosteal circumference increased, leading to decreased cortical thickness. Muscle area decreased, while muscle density was unchanged. A high cross-sectional area and low bone volumetric bone mineral density were predictive of fracture during the follow-up.
Conclusion: Over a mean follow-up of 7 years, postmenopausal women lose bone mineral density, associated with a decrease in cortical thickness in the forearm.
{"title":"Site-specific volumetric skeletal changes in women with and without a distal forearm fracture: a case-control study with a mean 7-year follow-up.","authors":"Paul Gerdhem, Axel Wihlborg, Ingrid B Bergström","doi":"10.1007/s00198-025-07412-5","DOIUrl":"10.1007/s00198-025-07412-5","url":null,"abstract":"<p><p>Brief rationale: To assess bone dimensions in the radius over 7 years.</p><p><strong>Main result: </strong>Cross-sectional area did not change significantly, but endosteal circumference increased, leading to decreased cortical thickness. Significance of the paper: Bone mineral density loss is associated with a decrease in cortical thickness in the forearm.</p><p><strong>Purpose: </strong>To assess site-specific volumetric bone and muscle differences in women with and without forearm fracture in a longitudinal study.</p><p><strong>Methods: </strong>One hundred four postmenopausal women with a forearm fracture and 99 age-matched controls were included and underwent peripheral quantitative computed tomography (pQCT) in the forearm at a mean age of 65 (range 44-88) years and were invited for a reassessment after mean 7 (6-11) years, at which 80 and 79 women took part, respectively. Three cases had movement artifacts on pQCT; 77 cases and 79 controls were finally analysed.</p><p><strong>Results: </strong>Twenty-two of the cases and 20 of the controls sustained a fracture during the follow-up. From baseline to follow-up, bone mineral content and bone mineral density decreased irrespective of group belonging at baseline, both at the 4% and the 66% level in the forearm. Cross-sectional area did not change significantly at the 4% and the 66% level. At the 66% level, periosteal circumference was unchanged and endosteal circumference increased, leading to decreased cortical thickness. Muscle area decreased, while muscle density was unchanged. A high cross-sectional area and low bone volumetric bone mineral density were predictive of fracture during the follow-up.</p><p><strong>Conclusion: </strong>Over a mean follow-up of 7 years, postmenopausal women lose bone mineral density, associated with a decrease in cortical thickness in the forearm.</p>","PeriodicalId":19638,"journal":{"name":"Osteoporosis International","volume":" ","pages":"875-882"},"PeriodicalIF":4.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12089192/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143670329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}