INTRODUCTION:The postmenopausal bone health reflects the influence of various factors that have been in effect throughout life and hormonal regulation is among them. The aim of the current study is to investigate the effect of pregnancies and other factors related to female reproductive health on bone mineral density and the incidence of fractures in the postmenopausal period. MATERIAL AND METHODS:We performed a case-control retrospective analysis in a group of 977 postmenopausal women from the RACOST-POL cohort. RESULTS:In the study group, there were 894 (91.5%) women who had at least one delivery and breastfeeding was reported by 845 (86.5%) women. Bone mineral density (FN T-score) was not related to pregnancies and history of lactation, but correlated positively with age at menopause and with time of reproductive period. Low-energy fractures were reported by 286 women, which consists 29.3% of the study group. There was no difference in fracture prevalence between women who delivered (29.4%) or not (27.7%). Also the breastfeeding status was not related to fracture prevalence (28.9% in the subgroup declaring lactation and 31.8% in the others). Women with fractures had earlier age of menopause and shorter time of reproductive period in comparison to subjects without fractures (48.3 ± 5.2 vs. 49.5 ± 4.7 ys.; p < 0.001; OR 0.95 (95% CI: 0.93 - 0.98), and 34.1 ± 5.5 vs. 35.5 ± 4.9 ys.; p < 0.001; OR 0.95 (95% CI: 0.93 - 0.98), respectively). Additionally, fracture prevalence in the 'early menopause' (below 45 ys) subgroup was significantly higher (39.1%) than in all the others (27.8%) with OR 1.66 (95% CI: 1.13 - 2.42). CONCLUSIONS:Our study did not show a significant association between history of pregnancies or lactation and the skeletal status in the postmenopausal period. However, a shortened period between menarche and menopause and an earlier age at menopause may have a negative impact on bone health in later life. Presented results complement the knowledge on a wide and diverse spectrum of factors modifying bone health in postmenopausal women.
The study presents osteoporotic fracture risk in postmenopausal women established by FRAX, Garvan and POL-RISK algorithms for next 10 years. In studied group, a relatively high level of fracture risk was shown. These findings emphasize the importance of increasing treatment to reduce the expected rise in fracture rate in the future. The aim of the study was to assess the 10-year osteoporotic fracture risk of postmenopausal women using the FRAX, Garvan, and POL-RISK algorithms and to compare those tools in terms of identification of high-risk subjects. The study group consisted of 508 consecutive postmenopausal women recruited in three osteoporotic outpatient clinics. Mean age was 69.8 ± 7.5 years. Data on clinical risk factors were collected. Bone status was assessed at the hip using a Lunar Prodigy device. Fracture risk was established by FRAX, Garvan, and POL-RISK algorithms for the next 10 years. Mean risk for major fractures for FRAX was 8.85 ± 5.43
INTRODUCTION:The aim of the study was to present the role of socioeconomic factors in fracture risk among postmenopausal women. MATERIAL AND METHODS:The study group consisted of 508 consecutive postmenopausal women recruited from three osteoporotic outpatient clinics. The mean age was 69.8 ± 7.5 years. Data on clinical factors, as well as urban/rural residence, education, occupation, and maritalstatus, were collected. Bone status was assessed at the hip using a Lunar Prodigy device. Fracture risk over the next 10 years, expressedas a percentage, was established using the FRAX (major fractures), Garvan (any fractures), and POL-RISK (any fractures) algorithms. RESULTS:The mean risk was 8.95 ± 6.43% for FRAX and 29.71 ± 20.53% and 28.1 ± 14.85% for Garvan and POL-RISK, respectively. Fracture risk calculated by any of the analyzed calculators was not influenced by place of residence or level of education. The type of job was relatedto fracture risk according to the FRAX major calculator only; the risk was significantly higher in the unemployed group compared with thethree remaining subgroups - those performing sedentary work, physical work, or standing work. The type of work had no effect onthe risk according to the other calculators. Although marital status, particularly widowhood, was associated with higher fracture risk inunivariate analysis, this effect was not significant after adjustment for age, suggesting that age is the underlying factor. CONCLUSIONS:Socioeconomic factors were associated with fracture risk, and data on socioeconomic status should be incorporated into patient assessment for osteoporosis.
Objectives:To demonstrate therapeutic equivalence of the proposed denosumab biosimilar FKS518 to the originator denosumab (US-licensed Prolia®, reference product), a potent antiresorptive biologic that increases bone mineral density (BMD) and reduces the risk of fractures, in women with postmenopausal osteoporosis. Methods:This 78-week double-blind, controlled, randomized, multicenter, multiple-dose, 2-arm, parallel-group study compared the efficacy (BMD), pharmacodynamic (bone biomarkers), safety, tolerability, and immunogenicity profiles of FKS518 with those of reference denosumab in women with postmenopausal osteoporosis. Primary-percentage change from baseline to 52 weeks in lumbar spine BMD and area under the effect curve from baseline to week 26 of serum C-terminal cross-linking telopeptide of type 1 collagen-and secondary results from the 52-week core treatment period are reported here. Results:Postmenopausal women with osteoporosis were randomized to receive 60 mg of FKS518 (n = 277) or reference denosumab (n = 276) every 26 weeks. Demographics, baseline characteristics and medical history were similar between treatment groups. Therapeutic equivalence of FKS518 and reference denosumab was demonstrated for efficacy and pharmacodynamic characteristics. All sensitivity analyses, supportive estimands, secondary efficacy, and pharmacodynamic endpoint analyses consistently showed similarity between the 2 products. Safety outcomes were consistent with the known safety profile of denosumab and were comparable between FKS518 and reference denosumab. Immunogenicity was infrequently observed and similar between the FKS518 and the reference denosumab groups. Conclusion:This study demonstrated therapeutic equivalence of, and comparable pharmacokinetics, safety, and immunogenicity profiles between FKS518 and reference denosumab, completing the clinical evidence to propose FKS518 as a biosimilar to denosumab.
INTRODUCTION: The aim of the study was to present the optimal way of use in daily practice the methods designed for fracture risk assessment. MATERIAL AND METHODS: The study presents methods designed for fracture risk assessment. Among the long list of available methods, only some may be recommended for use in daily practice. Obvious necessity of simplicity, short duration of calculation of fracture risk, and reliability of method clearly indicate that only algorithms available as Webpage fulfil these expectations. Algorithms FRAX, Garvan, Qfracture, and POL-RISK allow for quick assessment according to the described conditions. Fracture risk is commonly established for the next 10 years for hip, major, or any fractures and expressed by percent of risk. RESULTS: The essential conditions of optimal use of methods for fracture risk assessment were presented and discussed. The following points were included: methodology, conformity, and recommended thresholds as medical and economic considerations. CONCLUSIONS: The optimal use of methods designed for fracture risk assessment require several steps. Independently of these essential conditions, one should remember that always in management each patient must be individually assessed. The pharmacologic therapy should always be started according to the level of fracture risk and other factors not included in the assessment of fracture risk.
INTRODUCTION:Osteoporosis is one of the most common diseases in elderly subjects. Accurate assessment of fracture risk is essential in the management of osteoporotic patients. The aim of the study was to present the optimal manner of using a method designed for fracture risk prediction, e.g. POL-RISK, in daily practice. MATERIAL AND METHODS:Methods for fracture prediction were presented, especially those which allow easy and quick online assessment. In addition to true medical aspect, e.g. the ability to accurately detect high fracture risk patients who need therapy, the economic aspects were also presented. Due to the enormous number of osteoporotic patients the therapy should be indicated mainly in patients with high fracture risk. The optimal threshold of fracture risk for the initiation of reimbursed therapy should be established as a compromise of prior established medical threshold and economic aspects. The expected endpoint is the reduction of new fractures noted in longitudinal observation. CONCLUSION:Implementation of the described scenario should enable the development of the optimal model of care in osteoporotic subjects. Broad use of fracture risk thresholds to initiate reimbursed therapy, encompassing both true medical and economic aspects, should result in the reduction of osteoporotic fractures and decrease overall osteoporosis-related costs to the healthcare system.
INTRODUCTION:In daily practice the diagnostic process for osteoporosis in elderly patients should also include physical assessment. The aim of the study was to verify the hypothesis that height loss (HL) predicts fracture incidence.MATERIAL AND METHODS:The study was performed in an epidemiological sample of postmenopausal women recruited in the RAC-OST-POL study. At baseline, data were collected in 978 postmenopausal women at a mean age of 66.48±7.6 years, and at 10-year follow-up 640 patients remained, with a mean age of 75.04 ± 6.95 years. Current height and HL were established in regard to maximal life height. Data on fracture incidence were gathered throughout the period of observation.RESULTS:During the follow-up period 190 osteoporotic fractures were noted. Ninety-one women had one fracture, and in 38 women, multiple fractures occurred. In the fractured and unfractured subgroups, HL was 5.45 ± 3.28 and 4.8 ± 3.56 cm, respectively, and differed significantly (p < 0.05). HL in subjects without fracture did not differ from those with one fracture (HL 4.8 ± 3.56 vs. 4.8 ± 2.66 cm, respectively). For patients with more than one fracture HL was 7.03 ± 4.06 cm and was significantly higher than in subjects with one or without any fracture (p < 0.01). Based on receiver operating characteristic (ROC) analysis, HL of 6 cm was identified as the cut-off point for high risk of multiple fractures.CONCLUSION:HL of at least 6 cm is the predictor of multiple fractures in a prospective observation of a representative epidemiological female sample. Therefore, the measurement of HL should always be included in patients' assessments.
Background: Postmenopausal osteoporosis is not only related to hormonal factors but is also associated with environmental and genetic factors. One of the latter is the polymorphism of vitamin D receptor (VDR). The aim of the reported study was to comprehensively analyze the VDR gene polymorphic variants rs731236 (TaqI), rs1544410 (BsmI) and rs7975232 (ApaI) in the Polish population of postmenopausal women. Methods: The study group consisted of 611 women after menopause (their median age was 65.82 ± 6.29 years). Each of them underwent bone densitometry (DXA) of the non-dominant femoral neck and total hip with a biochemical analysis of vitamin D3 serum concentration and genotyping of the above-mentioned single nucleotide polymorphisms (SNPs); the obtained results were analyzed in the aspect of waist circumference (WC), body mass index (BMI) and past medical history. Results: The genotype prevalence rates of all SNPs were compatible with Hardy–Weinberg equilibrium (p > 0.050). Out of the studied polymorphisms, only rs731236 genotype variants affected DXA, with AG heterozygotes showing the worst bone parameters. Neither patient age nor vitamin D3 concentration, BMI, WC or comorbidities was associated with rs731236 genotype. Conclusions: Out of the polymorphisms studied, only rs731236 genotypes differed among the DXA results, while the AG heterozygotes were characterized by the lowest median bone mineral density.
Introduction: The aim of the study was presentation of the data on falls in a cohort of postmenopausal women in a 10-year prospective longitudinal observation. Material and methods: 640 postmenopausal women at baseline age above 55 years were included. The cohort was randomly selected from the population of the whole Racib & oacute;rz district. Data on falls and fracture incidence were gathered yearly. Results: 256 (40%) women had no falls, and in 384 (60%) subjects at least one fall was noted. The number of women with 1, 2, and 3 or more falls were 115, 62, and 207, respectively. The total number of falls was 1988. Mean baseline age in those who noted falls was 65.7 +/- 7.02 years, and it was significantly higher than in the rest of the patients (64.1 +/- 6.75; p<0.01). Duringfollow-up 190 osteoporotic fractures were noted in 129 patients. Falls were proven to have a strong, significant relationship with fracture (chi-square test = 80.5; p < 0.0001). Among potential clinical factors only diabetes type 1 (chi-square test = 5.80; p < 0.05) and depression (chi-square test = 3.82; p < 0.05) influenced falls incidence. The risk of falls was increased in cases of greater numbers of clinical risk factors (chi-square test = 28.4 df = 5; p < 0.0001). Conclusions: In long-term follow-up in postmenopausal women, falls were frequently observed, and their occurrence increased the frac- ture rate. Diabetes type 1 and depression increase the fall rate, which suggests the necessity of implementation of some preventive procedures. (Endokrynol Pol 2024; 75 (5): 543-547)
Background. Osteoporosis is a metabolic disease characterized by increased bone fragility. As it is characterized as a general skeletal disease, changes can also be seen in the stomatognathic system (edentulism, wrong fitting of dentures, etc.). The question is whether early changes in the salivary mineral content and acid-base balance may reflect skeletal status and risk of bone fracture. Objectives. The objective of the study was to evaluate whether minerals in the saliva were associated with skeletal fractures in a population of postmenopausal women. Materials and methods. In this observational study, dental examinations along with the collection of saliva were conducted in 117 randomly recruited women (mean age 64.6 +/- 5.9 years). The study group included 23 study participants with fractures, of which 10 had a history of osteoporotic fractures. Saliva samples for mineral content including copper (Cu), zinc (Zn), calcium (Ca), and phosphorus (P), as well as salivary pH were collected and analyzed to determine associations between salivary mineral content and fracture risk. Results. As a result, the median pH value was 6.8, and the median levels for Cu (0.35 mu mol/L), Zn (0.61 mu mol/L), Ca (0.7 mmol/L), and P (6.64 mmol/L) were observed. No differences were noted in salivary mineral content and acid-basic balance between the fractured and non-fractured participants. Conclusions. The results of our study suggest that salivary mineral content has limited usability in predicting skeletal fragility in postmenopausal women when used alone.
Introduction: The aim of the study was to present data on risk factors for fractures in various parts of the skeleton in a cohort of postmenopausal women during a 10-year prospective observation period. It can be hypothesised that fracture risk factors should be different for spine, hip, and peripheral fractures. Material and methods: 640 postmenopausal women at mean baseline age was 65.0 +/- 6.9 years were enrolled into the study. The cohort was randomly selected from the population of the entire Racib & oacute;rz district. Data on the incidence of fractures and falls were updated annually during the 10-year follow-up period. Information on clinical risk factors for fractures was collected at baseline. Results: During the observation period, 190 low-traumatic fractures were recorded in 129 patients. The following number of fractures was observed: hip 15, spine 30, non-hip fractures other than spine 145 (including 81 forearm fractures). The effect of falls was insignificant in the case of spine fractures (chi-square test: 3.64; p = 0.06). For all other skeletal sites, the incidence of fractures was significantly increased by falls, with the greatest effect observed for forearm fractures and non-spine and non-hip fractures (chi-square test for hip, forearm, and all non-spine, non-hip fractures was 6.43, p < 0.05; 42.7, p < 0.0001 and 66.7, p < 0.0001, respectively). To determine the factors having a significant impact on the incidence of fractures during the observation period, logistic regression was used separately in subgroups. The following risk factors were taken into account: age, height, body weight, bone mineral density (BMD) at the femoral neck as expressed by T-score, rheumatoid arthritis, steroid use, falls reported at baseline, and the total number of risk factors. Spine fractures depended only on T-score, odds ratio (OR) = 0.42 (0.23-0.76); hip fractures depended only on age, OR = 1.15 (1.07-1.24); forearm fractures depended only on age T-score, OR = 0.69 (0.51-0.92); and non-hip, non-spine on fall rate, OR = 1.86 (1.20-2.87). Conclusions: Fractures at various skeletal sites recorded in long-term follow-up in postmenopausal women were dependent on various risk factors. Multivariate analysis identified a single, dominant risk factor for each fracture location analysed.
In the longitudinal, retrospective study, the ability of the FRAX, Garvan, and POL-RISK algorithms to predict osteoporotic fractures was compared in a group of 457 women. Using the rigid threshold of 10
Dairy products, a major source of calcium, demonstrate a number of beneficial effects, not only protecting against the development of osteoporosis (OP) but also suppressing the onset of type-2 diabetes (T2DM) and improving bone mineral density (BMD). Dairy consumption is closely linked to lactose tolerance. One of the genetic factors predisposing individuals to lactose intolerance is rs4988235 polymorphism of the MCM6 gene. The aim of this reported study was to analyse the relationship between the rs4988235 variant of the MCM6 gene and bone mineral density and the risk of type-2 diabetes in women after menopause. Methods: The study was conducted among 607 female patients in the postmenopausal period in whom bone densitometry and vitamin-D3 levels were assayed and genotyping of the rs4988235 polymorphism of MCM6 gene was performed. The obtained results were analysed for the presence of T2DM, obesity surrogates, medical data, and past medical history. Results: The distribution of genotype frequencies was consistent with the Hardy–Weinberg equilibrium (p > 0.050). Postmenopausal women with the GG homozygote of rs4988235 polymorphism consumed significantly less calcium (dairy), which was probably related to the observed lactose intolerance. The GG homozygote of women with rs4988235 polymorphism was significantly more likely to have T2DM relative to the A allele carriers (p = 0.023). GG homozygotes had significantly lower femoral–vertebral mineral density despite the significantly more frequent supplementation with calcium preparations (p = 0.010), vitamin D (p = 0.01), and anti-osteoporotic drugs (p = 0.040). The obtained results indicate a stronger loss of femoral-neck mineral density with age in the GG homozygotes relative to the A allele carriers (p = 0.038). Conclusions: In the population of women after menopause, the carriage of the G allele of rs4988235 polymorphism of the MCM6 gene, i.e., among the patients with lactose intolerance, significantly increased the risk of developing T2DM and the loss of BMD.
INTRODUCTION:In the previous report, we noted a significant increase in hip fracture incidence in the local study area. The aim of the study was the continuous observation of hip fracture incidence in the local community over the last 20 years and to estimate their projection for the next 30 years. METHODS:Medical records of the patients aged 50 years and older in the period 2002 - 2021 (local data - area of the district Tarnowskie Góry and the city of Piekary Śląskie) with diagnosis ICD-10: S72.0; S72.1; and S72.2 (only the fragility fractures) were taken into analysis. RESULTS:2,723 fragility hip fractures in the local area were registered (72 % in women). The increase in the rate was constantly observed, even during the COVID - 19 pandemic. The incidence rate ratio for the local population increased to 1.41. The incidence rate in 2021 was for the total population 230.2 (men 151.3; women 294.2). For comparison in 2002, it was 129.0 (men 48.8; women 192.4). In 2050 the number of fractures according to our new estimation will increase. CONCLUSIONS:The number of fragility hip fractures in Polish men and women aged over 50 years in the local population increased. The epidemiological situation is still worsening. Therefore, especially due to the reduction of orthopedic beds and the aging population phenomenon the situation will be tragic to our patients.
Background: The clinical significance of the genetic influence of vitamin D receptor polymorphisms has still not been well-analyzed. Objectives: To verify whether rs1544410, rs7975232 and rs731236 polymorphisms are associated with a higher 10-year fracture risk in postmenopausal women. Methods: The study group was a subset of a pre-defined population as part of the broader epidemiological research called the RAC-OST-POL Study and consisted of 358 postmenopausal women, chosen randomly from Racibórz (Poland) inhabitants (mean baseline age 65 ± 6.9 years, BMI 31.2 ± 5.5 kg/m2). From all participants’ medical history, data concerning co-morbidities, fracture history, the medication used, parental history of bone fractures, cigarettes and alcohol use were taken at baseline. Moreover, rs1544410, rs7975232 and rs731236 polymorphisms were analyzed. Next, over the following 10 years, participants were contacted once a year and questioned concerning new fractures events and their circumstances. Results: We did not find statistically significant main effects on the fracture incidence of single-polymorphism variants. However, there were some significant findings dependent on the co-existence of these polymorphisms and medical factors. Women with a positive history of parental fracture and configuration of CC rs7975232, AA rs731236 and CC rs1544410 had a higher fracture incidence. The risk of bone fracture was also significantly higher in the group of heterozygotes of AC rs7975232 if their BMI value was in the categories of normal weight or overweight, or if they were treated with calcium or vitamin D. Conclusions: Polymorphisms of rs1544410, rs7975232 and rs731236 are connected with the fracture incidence in postmenopausal women. Nevertheless, its influence should be considered with co-existing clinical factors, especially paternal fracture history, prior fracture, BMI value, any osteoporotic treatment or calcium/vit. D supplementation.
Despite different lifestyles, humankind has suffered from osteoporosis for thousands of years. A literature review concerning the history of osteoporosis in the following databases: Index Medicus, Medline, PubMed, and PMC Citations was done. In the final analysis, 18 review articles and 31 original papers were included. The works were published during the period 1705-2020. Although there is evidence of the existence of osteoporosis for many centuries, it was first described as a disease at the beginning of the 18th century. It was first perceived as an unavoidable course of aging with no possibility to cure. This approach changed only in the 20th century thanks to sudden diagnostic and therapeutic progress. This paper presents the milestones and most important researchers in osteoporosis history. Rapid progress in diagnostic and therapeutic possibilities sheds new light on osteoporosis' nature. A comprehensive outlook on its history may help find answers for the still unsolved problems of this disease.
Background and objectives: Osteoporosis and vitamin D3 deficiency may be risk factors of benign paroxysmal positional vertigo (BPPV). The aim of this study was to assess the prevalence of osteoporosis and 25(OH) vitamin D3 deficiency in a group of patients with idiopathic benign paroxysmal positional vertigo. Materials and Methods: Thirty-five patients (twenty-eight women and seven men) with posterior semicircular canal BPPV were enrolled in the study. The subjects underwent hearing assessment (tonal audiometry and impedance audiometry) and the Dix-Hallpike maneuver. Serum 25(OH) vitamin D3 levels were determined and lumbar spine bone densitometry was performed. The relationships between sex, age, height, Body Mass Index (BMI), vitamin D3 levels and bone densitometry results were assessed. Results: The diagnosis of osteoporosis was confirmed in 1 patient (3%), 3 subjects were osteopenic (8.6%), and normal bone densitometry was found in 31 (88.6%) patients. Conclusions: We found no statistically significant relationships between age, BMI or vitamin D3 levels and bone densitometry results in patients with idiopathic BPPV.