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Article ; Online: The Five-Year Effect of a Single Zoledronate Infusion on Bone Mineral Density Following Denosumab Discontinuation in Women with Postmenopausal Osteoporosis.

Anastasilakis, Athanasios D / Makras, Polyzois / Polyzos, Stergios A / Papapoulos, Socrates E

2023 Volume 113, Issue 4, Page(s) 469–473

Abstract: The long-term effects of zoledronate treatment in women with postmenopausal osteoporosis who stop denosumab therapy when they become osteopenic are not known. In a prospective, randomized, controlled clinical trial we previously reported that a single ... ...

Abstract	The long-term effects of zoledronate treatment in women with postmenopausal osteoporosis who stop denosumab therapy when they become osteopenic are not known. In a prospective, randomized, controlled clinical trial we previously reported that a single intravenous infusion of zoledronate 5 mg given to such patients 6 months after the last denosumab injection effectively prevents bone loss in the majority of them for up to 3 years. The study was extended for an additional 2 years and included all 19 patients from one Trial Site of the total 27 patients originally randomized in the zoledronate arm. Baseline characteristics of this cohort treated with denosumab for 2.4 ± 0.2 years were not different from those of the whole initial cohort or from the patients who did not participate in this extension. At the end of 5 years 7 patients had become again osteoporotic requiring additional treatment, 9 remained osteopenic while 3 did not complete the study extension. Thus, more than half of the osteoporotic women who became osteopenic with denosumab treatment and stopped it, maintained the BMD gains 5 years after a single zoledronate infusion with no additional treatment. Whether these results are also applicable to patients treated with denosumab for longer periods remains to be established.
MeSH term(s)	Humans ; Female ; Osteoporosis, Postmenopausal/drug therapy ; Zoledronic Acid/therapeutic use ; Denosumab ; Bone Density ; Bone Density Conservation Agents ; Prospective Studies
Chemical Substances	Zoledronic Acid (6XC1PAD3KF) ; Denosumab (4EQZ6YO2HI) ; Bone Density Conservation Agents
Language	English
Publishing date	2023-08-03
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	304266-2
ISSN	1432-0827 ; 0944-0747 ; 0008-0594 ; 0171-967X
ISSN (online)	1432-0827
ISSN	0944-0747 ; 0008-0594 ; 0171-967X
DOI	10.1007/s00223-023-01119-7
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Article ; Online: Questions and facts regarding denosumab discontinuation among postmenopausal women.

Makras, Polyzois / Anastasilakis, Athanasios D

Expert opinion on drug safety

2020 Volume 20, Issue 5, Page(s) 499–501

MeSH term(s)	Bone Density Conservation Agents/administration & dosage ; Denosumab/administration & dosage ; Female ; Humans ; Osteoporosis, Postmenopausal/drug therapy ; Postmenopause ; Time Factors
Chemical Substances	Bone Density Conservation Agents ; Denosumab (4EQZ6YO2HI)
Language	English
Publishing date	2020-12-29
Publishing country	England
Document type	Editorial
ZDB-ID	2088728-0
ISSN	1744-764X ; 1474-0338
ISSN (online)	1744-764X
ISSN	1474-0338
DOI	10.1080/14740338.2021.1867102
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Zs.A 6096: Show issues

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Article: Adult Langerhans Cell Histiocytosis and the Skeleton.

Georgakopoulou, Danae / Anastasilakis, Athanasios D / Makras, Polyzois

Journal of clinical medicine

2022 Volume 11, Issue 4

Abstract: Langerhans cell histiocytosis (LCH) is a rare inflammatory neoplasia in which somatic mutations in components of the MAPK/ERK pathway have been identified. Osseous involvement is evident in approximately 80% of all patients and may present as a single ... ...

Abstract	Langerhans cell histiocytosis (LCH) is a rare inflammatory neoplasia in which somatic mutations in components of the MAPK/ERK pathway have been identified. Osseous involvement is evident in approximately 80% of all patients and may present as a single osteolytic lesion, as a multi-ostotic single system disease or as part of multisystem disease. Both exogenous, such as treatment with glucocorticoids, and endogenous parameters, such as anterior pituitary hormone deficiencies and inflammatory cytokines, may severely affect bone metabolism in LCH. Computed tomography (CT) or magnetic resonance imaging (MRI) are usually required to precisely assess the degree of bone involvement; 18F-fluorodeoxyglucose (FDG) positron emission tomography-CT can both detect otherwise undetectable LCH lesions and differentiate metabolically active from inactive or resolved disease, while concomitantly being useful in the assessment of treatment response. Treatment of skeletal involvement may vary depending on location, extent, size, and symptoms of the disease from close observation and follow-up in unifocal single-system disease to chemotherapy and gene-targeted treatment in cases with multisystem involvement. In any case of osseous involvement, bisphosphonates might be considered as a treatment option especially if pain relief is urgently needed. Finally, a patient-specific approach is suggested to avoid unnecessary extensive surgical interventions and/or medical overtreatment.
Language	English
Publishing date	2022-02-09
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2662592-1
ISSN	2077-0383
ISSN	2077-0383
DOI	10.3390/jcm11040909
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Article ; Online: Transient osteoporosis of the hip following discontinuation of denosumab and switch to alendronate treatment.

Makras, Polyzois / Yavropoulou, Maria P / Anastasilakis, Athanasios D / Papatheodorou, Athanasios / Tekedis, Christos / Papapoulos, Socrates E

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA

2023 Volume 35, Issue 4, Page(s) 741–743

MeSH term(s)	Humans ; Female ; Alendronate/therapeutic use ; Denosumab/therapeutic use ; Osteoporosis/drug therapy ; Bone Density Conservation Agents/therapeutic use ; Osteoporosis, Postmenopausal/drug therapy
Chemical Substances	Alendronate (X1J18R4W8P) ; Denosumab (4EQZ6YO2HI) ; Bone Density Conservation Agents
Language	English
Publishing date	2023-12-26
Publishing country	England
Document type	Letter ; Comment
ZDB-ID	1064892-6
ISSN	1433-2965 ; 0937-941X
ISSN (online)	1433-2965
ISSN	0937-941X
DOI	10.1007/s00198-023-07000-5
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Zs.A 3163: Show issues

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Article ; Online: Fracture risk among treatment-naïve postmenopausal women with osteopenia in Greece: results from the "ACROSS" study.

Anastasilakis, Athanasios D / Makras, Polyzois

Archives of osteoporosis

2020 Volume 15, Issue 1, Page(s) 163

Abstract: Use of the FRAX (Fracture Risk Assessment Tool) tool to assess fracture risk is the most common practice worldwide. Our findings suggest that in treatment-naïve women with osteopenia treatment would be cost-effective for approximately one-third of the ... ...

Abstract	Use of the FRAX (Fracture Risk Assessment Tool) tool to assess fracture risk is the most common practice worldwide. Our findings suggest that in treatment-naïve women with osteopenia treatment would be cost-effective for approximately one-third of the study population and nearly half of the subjects over 75 years, according to the Greek-specific FRAX-based thresholds. Introduction: When evaluating a patient with low bone mineral density (BMD), fracture risk estimation is of paramount importance. Fracture risk assessment using the FRAX tool is the most common and most studied practice worldwide. Patients-methods: The primary aim of the "ACROSS" study was to record the 10-year probability of major osteoporotic fractures and hip fractures, using the Greek version of the FRAX tool, in a rather representative population of 230 postmenopausal treatment-naïve women with osteopenia. Secondary aims of the study were to identify (1) the risk for fractures according to age and the years from menopause, (2) the proportion of patients qualifying for treatment according to the Greek cost-effective FRAX thresholds, and (3) the perception of both the patient and the treating physician regarding the estimated fracture risk. Results: The mean 10-year risk was 10.7% ± 6.6 for major osteoporotic fractures and 3.4% ± 4.2 for hip fractures. For women up to 75 years of age, the 10-year risk for major osteoporotic and hip fractures was 8.8% and 2.1%, respectively, while for women over 75 years, the risk was 15.2% and 6.6%, respectively. Patients generally believed that they had low fracture risk independently of age, while the physicians considered that the risk increases with advancing age. Conclusions: According to the Greek-specific FRAX-based thresholds, the administration of osteoporosis treatment would be cost-effective for approximately one-third of the study population and nearly half of the subjects over 75 years. Patients are not fully aware of their fracture risk.
MeSH term(s)	Aged ; Aged, 80 and over ; Bone Density ; Bone Diseases, Metabolic/complications ; Bone Diseases, Metabolic/epidemiology ; Female ; Fractures, Bone/epidemiology ; Fractures, Bone/etiology ; Greece/epidemiology ; Humans ; Middle Aged ; Osteoporosis/complications ; Osteoporotic Fractures/epidemiology ; Osteoporotic Fractures/etiology ; Postmenopause ; Risk Assessment/methods ; Risk Factors
Language	English
Publishing date	2020-10-16
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2253231-6
ISSN	1862-3514 ; 1862-3522
ISSN (online)	1862-3514
ISSN	1862-3522
DOI	10.1007/s11657-020-00837-x
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Article: Similarities and Differences in the Management of Patients with Osteoporotic Vertebral Fractures and Those with Rebound-Associated Vertebral Fractures Following Discontinuation of Denosumab.

Anastasilakis, Athanasios D / Makras, Polyzois / Paccou, Julien / Bisbinas, Ilias / Polyzos, Stergios A / Papapoulos, Socrates E

Journal of clinical medicine

2023 Volume 12, Issue 18

Abstract: Rebound-associated vertebral fractures (RVFx) following denosumab discontinuation are typically multiple, are commonly associated with acute sharp pain, increase the risk of imminent fractures, and are pathogenetically different from common osteoporotic ... ...

Abstract	Rebound-associated vertebral fractures (RVFx) following denosumab discontinuation are typically multiple, are commonly associated with acute sharp pain, increase the risk of imminent fractures, and are pathogenetically different from common osteoporotic vertebral fractures (VFx). A clinically relevant question is whether patients with RVFx should be managed differently from patients with osteoporotic VFx. To address this question, we performed a systematic search of the PubMed database, and we reviewed current evidence on the optimal management of patients with RVFx. For pain relief of patients with RVFx, potent analgesics, often opioids, are essential. Information on the effectiveness of braces in these patients is scarce. Vertebroplasty and kyphoplasty are strongly contraindicated as they confer a substantial risk for new VFx. Exercise may be helpful, but again evidence is lacking. In contrast to patients with osteoporotic VFx, in whom initial treatment with bone-forming agents is recommended, patients with RVFx should initiate treatment with potent antiresorptives. To summarize, patients who have sustained RVFx following denosumab discontinuation are at a very high risk for new fractures, especially VFx. The management of such patients requires a multidisciplinary approach that should not be restricted to pain relief and administration of antiosteoporotic medication, but should also include back protection, early mobilization, and appropriate exercise.
Language	English
Publishing date	2023-09-10
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2662592-1
ISSN	2077-0383
ISSN	2077-0383
DOI	10.3390/jcm12185874
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Article ; Online: Skeletal implications of isolated bone marrow mastocytosis.

Makras, Polyzois

Haematologica

2011 Volume 96, Issue 4, Page(s) e27; author reply e28

MeSH term(s)	Bone Marrow/pathology ; Bone and Bones/pathology ; Humans ; Mastocytosis/diagnosis
Language	English
Publishing date	2011-03-31
Publishing country	Italy
Document type	Comment ; Letter
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2011.040881
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Article ; Online: To screen or not to screen for osteoporosis amongst post-menopausal women with one prior osteoporotic fracture in Greece.

Souliotis, Kyriakos / Golna, Christina / Golnas, Paul / Markakis, Ioannis-Anestis / Makras, Polyzois

Aging clinical and experimental research

2022 Volume 34, Issue 10, Page(s) 2473–2481

Abstract: Background: Screening and linkage to care (SLTC) for osteoporosis is suboptimal in several settings. In Greece, it is estimated that only up to 8.6% of postmenopausal women are SLTC for osteoporosis, despite having suffered a previous fracture.: Aims!# ...

Abstract	Background: Screening and linkage to care (SLTC) for osteoporosis is suboptimal in several settings. In Greece, it is estimated that only up to 8.6% of postmenopausal women are SLTC for osteoporosis, despite having suffered a previous fracture. Aims: This study aims to estimate the impact of comprehensive screening on future fracture burden amongst post-menopausal women aged 50-74, with one prior osteoporotic fracture, in Greece. Methods: We developed a cohort stochastic model, based on published epidemiological and clinical data, to assess impact of screening on future fracture burden in two scenarios: a current, assuming an 8.6% background SLTC, and a completely hypothetical, assuming 100% SLTC. Results: Amongst a cohort of 50,000 post-menopausal women aged 50-74, with one prior osteoporotic fracture, applying the hypothetical versus the current scenario would result in a reduction in deaths (-0.6%) and fractures (-4.3%) over 10 years. The hypothetical scenario leads to greater reductions in costs associated with vertebral (-8.1%) and hip (-5.5%) fractures, followed by other non-vertebral (-3.0%) and forearm (-2.5%) fractures. In the hypothetical scenario, treatment initiations and total screenings increased almost tenfold versus the current scenario, at an estimated direct incremental cost of 27.83€ per woman per year in the cohort. Discussion: Our study adds to the existing evidence on the impact of screening to prevent fractures amongst post-menopausal women. Despite being based on a stochastic model, our study confirms findings most recently published in the literature. Conclusions: Our study models the positive public health impact of increasing SLTC levels amongst post-menopausal women with a prior osteoporotic fracture.
MeSH term(s)	Female ; Humans ; Osteoporotic Fractures/diagnosis ; Osteoporotic Fractures/epidemiology ; Osteoporosis, Postmenopausal/complications ; Osteoporosis, Postmenopausal/diagnosis ; Osteoporosis, Postmenopausal/epidemiology ; Postmenopause ; Greece/epidemiology ; Osteoporosis/complications ; Osteoporosis/diagnosis ; Osteoporosis/epidemiology
Language	English
Publishing date	2022-07-11
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2104785-6
ISSN	1720-8319 ; 1594-0667
ISSN (online)	1720-8319
ISSN	1594-0667
DOI	10.1007/s40520-022-02183-z
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Zs.A 3343: Show issues

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Article ; Online: Association of activins, follistatins and inhibins with incident hip fracture in women with postmenopausal osteoporosis: a proof of concept, case-control study.

Anastasilakis, Athanasios D / Polyzos, Stergios A / Savvidis, Matthaios / Anastasilakis, Dimitrios A / Sarridimitriou, Athanasios / Kumar, Ajay / Kalra, Bhanu / Makras, Polyzois / Mantzoros, Christos S

Endocrine

2023 Volume 81, Issue 3, Page(s) 573–578

Abstract: Purpose: The activins-follistatins-inhibins (AFI) hormonal system is considered to regulate muscle and bone mass. We aimed to evaluate AFI in postmenopausal women with an incident hip fracture.: Methods: In this post-hoc analysis of a hospital based ... ...

Abstract	Purpose: The activins-follistatins-inhibins (AFI) hormonal system is considered to regulate muscle and bone mass. We aimed to evaluate AFI in postmenopausal women with an incident hip fracture. Methods: In this post-hoc analysis of a hospital based case-control study, we evaluated circulating levels of the AFI system in postmenopausal women with a low-energy hip fracture admitted for fixation compared with postmenopausal women with osteoarthritis scheduled for arthroplasty. Results: Circulating levels of follistatin (p = 0.008), FSTL3 (p = 0.013), activin B and AB (both p < 0.001), as well as activin AB/follistatin and activin AB/FSTL3 ratios (p = 0.008 and p = 0.029, respectively) were higher in patients than controls in unadjusted models. Differences for activins B and AB remained after adjustment for age and BMI (p = 0.006 and p = 0.009, respectively) and for FRAX-based risk for hip fracture (p = 0.008 and p = 0.012, respectively) but were lost when 25OHD was added to the regression models. Conclusions: Our data indicate no major changes in the AFI system in postmenopausal women at the time of hip fracture compared to postmenopausal women with osteoarthritis except for higher activin B and AB levels, whose significance, however, was lost when 25OHD was added to the adjustment models. Clinical trials: Clinical Trials identifier: NCT04206618.
MeSH term(s)	Humans ; Female ; Inhibins/analysis ; Follistatin ; Case-Control Studies ; Osteoporosis, Postmenopausal/epidemiology ; Glycoproteins/analysis ; Activins
Chemical Substances	Inhibins (57285-09-3) ; Follistatin ; Glycoproteins ; Activins (104625-48-1)
Language	English
Publishing date	2023-05-23
Publishing country	United States
Document type	Journal Article
ZDB-ID	1194484-5
ISSN	1559-0100 ; 1355-008X ; 0969-711X
ISSN (online)	1559-0100
ISSN	1355-008X ; 0969-711X
DOI	10.1007/s12020-023-03402-x
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Zs.A 3884: Show issues

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Article ; Online: Efficacy of denosumab monotherapy among adults with Langerhans cell histiocytosis: A prospective clinical trial.

Makras, Polyzois / Yavropoulou, Maria P / Chatziioannou, Sofia N / Anastasilakis, Athanasios D / Georgakopoulou, Danai / Tsoli, Marina / Chatzelis, Eleftherios / Kaltsas, Gregory

American journal of hematology

2023 Volume 98, Issue 7, Page(s) E168–E171

Abstract: This phase IIb clinical trial evaluated the efficacy of a bimonthly treatment schedule (Q8W) with 4 subcutaneous doses of denosumab 120 mg among adults with Langerhans cell histiocytosis needing first-line systemic therapy for either multifocal single- ... ...

Abstract	This phase IIb clinical trial evaluated the efficacy of a bimonthly treatment schedule (Q8W) with 4 subcutaneous doses of denosumab 120 mg among adults with Langerhans cell histiocytosis needing first-line systemic therapy for either multifocal single-system disease or multisystem disease without risk organ involvement. Two months after the last treatment administration, seven patients showed disease regression, one stable disease, one non-active disease, and one disease progression. One year after treatment, progression was evident in two patients, while the remaining exhibited either a regression (three patients) or non-active disease (five patients). No permanent sequalae developed during the study and no adverse events were adjudicated in treatment. In conclusion, four doses of denosumab 120 mg Q8W subcutaneously are an effective treatment option in Langerhans cell histiocytosis patients without risk organ involvement exhibiting a response rate of 80%. Further studies are needed to confirm its role as a disease modifying agent.
MeSH term(s)	Adult ; Humans ; Denosumab/therapeutic use ; Histiocytosis, Langerhans-Cell/drug therapy ; Prospective Studies ; Treatment Outcome
Chemical Substances	Denosumab (4EQZ6YO2HI)
Language	English
Publishing date	2023-04-19
Publishing country	United States
Document type	Clinical Trial, Phase II ; Letter ; Research Support, Non-U.S. Gov't
ZDB-ID	196767-8
ISSN	1096-8652 ; 0361-8609
ISSN (online)	1096-8652
ISSN	0361-8609
DOI	10.1002/ajh.26936
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