Influence of patient perceptions and preferences for osteoporosis medication on adherence behavior in the Denosumab Adherence Preference Satisfaction study

The antiresorptive drug elcatonin (ECT) is known to relieve pain in postmenopausal women with osteoporosis. A prospective open-labeled trial was conducted to compare the effects of short-term combined treatment with alendronate (ALN) and ECT on bone mineral density (BMD) and bone turnover with those of single treatment with ALN in postmenopausal women with osteoporosis. Two hundred and five postmenopausal osteoporotic women (mean age: 70 years) were recruited in our outpatient clinic. Forty-six women with back pain were treated with ALN and ECT (intramuscular, 20 units a week), and 159 women without obvious back pain were treated with ALN alone. The lumbar BMD, urinary levels of cross-linked N-terminal telopeptides of type I collagen (NTX), and serum levels of alkaline phosphatase (ALP) were measured during the six-month treatment period. The baseline characteristics, except for age, body weight and number of patients with prevalent vertebral fractures, were not significantly different between the two groups. The mean increase rate in the lumbar BMD at six months was similar in the ALN (+4.41%) and ALN+ECT (+5.15%) groups, following similar reduction rates in urinary NTX levels (−40.2% and −43.0%, respectively, at three months) and serum ALP levels (−19.0% and −19.7%, respectively, at six months). These results were consistent even after adjustments for age, body weight, and number of patients with prevalent vertebral fractures. The present study in postmenopausal osteoporotic women confirmed that the effects of short-term combined treatment with ALN and ECT on lumbar BMD and bone turnover in patients with back pain appeared to be comparable to those of single treatment with ALN in patients without obvious back pain.

Endoscopic comparison of esophageal and gastroduodenal effects of risedronate and alendronate in postmenopausal women

This is a study extension to evaluate the efficacy and safety of long-term treatment with denosumab in postmenopausal women with low bone mass. Our objective was to describe changes in bone mineral density (BMD) and bone turnover markers as well as safety with 6 yr of denosumab treatment. We conducted an ongoing 4-yr, open-label, single-arm, extension study of a dose-ranging phase 2 trial. This paper reports a 2-yr interim analysis representing up to 6 yr of continuous denosumab treatment. This multicenter study was conducted at 23 U.S. centers. Of the 262 subjects who completed the parent study, 200 enrolled in the study extension and 178 (89%) completed the first 2 yr. All subjects received denosumab 60 mg sc every 6 months. We evaluated BMD at the lumbar spine, total hip, femoral neck, and one third radius; biochemical markers of bone turnover; and safety, reported as adverse events. Over a period of 6 yr, continuous treatment with denosumab resulted in progressive gains in BMD in postmenopausal women with low bone mass. Reduction in bone resorption was sustained over the course of continuous treatment. Independent of past treatment and discontinuation period, subjects demonstrated responsiveness to denosumab therapy as measured by BMD and bone turnover markers. The safety profile of denosumab did not change over time. In this study, denosumab was well tolerated and effective through 6 yr of continuous treatment in postmenopausal women with low bone mass.

Periostin is a secreted extracellular matrix protein preferentially expressed in bone by osteocytes and periosteal osteoblasts. Reduced periostin expression may affect osteoblast differentiation and collagen type I synthesis and predispose to osteoporosis and increased fracture risk. We aimed to evaluate circulating periostin levels in postmenopausal women with low bone mass, their possible correlations with clinical and laboratory parameters, as well as the 3-month effect of zoledronic acid. Serum samples for periostin, 25-hydroxyvitamin D, parathyroid hormone (PTH), C-terminal telopeptide of type I collagen (CTx), and total alkaline phosphatase (tALP) were obtained from 46 postmenopausal women with low bone mass at baseline and 3 months after zoledronic acid infusion and from 30 age-matched, postmenopausal controls with normal bone mass at baseline. There was no difference in periostin levels between women with normal and low bone mass (250±15 vs. 272±14 ng/ml, respectively; p=0.279). Periostin remained essentially unchanged after zoledronic acid infusion (262±18 ng/ml; p=0.130). Serum periostin levels at baseline were not affected by previous bisphosphonate treatment, and were correlated only to tALP (rs=0.351; p=0.018). In multiple linear regression analysis, tALP (B=3.17; 95% CI=0.59-5.79; p=0.018) was associated with serum periostin levels at baseline, independently from previous anti-osteoporotic treatment, age, body mass index, and 25-hydroxyvitamin D. In conclusion, serum periostin levels do not differ between postmenopausal women with normal and low bone mass and are not affected by zoledronic acid treatment. Women with higher tALP have independently higher periostin levels.

The relationship of low bone mass and fracture in younger postmenopausal women has not been extensively studied. In a large cohort of postmenopausal women > or =50 years of age, we found the relationship of BMD measured at peripheral sites and subsequent 1-year fracture risk to be similar between women <65 and those > or =65 years of age. Low bone mass and fractures are prevalent in older postmenopausal women. However, the frequency of low bone mass and fracture in younger postmenopausal women has not been studied extensively. There are very limited data regarding the association between BMD measurements and fractures in postmenopausal women who are between the ages of 50 and 64. In the National Osteoporosis Risk Assessment (NORA) we studied the frequency of low bone mass and its association with fracture in women 50-64 years of age in comparison with women > or =65 of age. NORA enrolled 200,160 postmenopausal women > or =50 years of age who had no prior diagnosis of osteoporosis. Baseline BMD was measured at the heel, forearm, or finger. A 1-year follow-up survey requesting incident fractures since baseline was completed by 163,935 women, 87,594 (53%) of whom were 50-64 years of age. The association between BMD and fracture was assessed using logistic regression, adjusted for important covariates. Thirty-one percent of women 50-64 years of age had low bone mass (T scores < or = -1.0) compared to 62% of women > or =65 years of age. During the first year of follow-up, 2440 women reported fractures of wrist/forearm, rib, spine, or hip, including 440 hip fractures. Nine hundred four women 50-64 years of age reported fractures, including 86 hip fractures, accounting for 37% of fractures and 20% of hip fractures reported in the entire NORA cohort. Relative risk for osteoporotic fracture was 1.5 for each SD decrease in BMD for both the younger and older groups of women. Low BMD in younger postmenopausal women 50-64 years of age showed a 1-year relative risk of fracture similar to that found in women > or =65 years of age.

Small birth size is associated with reduced adult bone mass. We determined if antenatal betamethasone exposure, birth weight, or prematurity affects peak bone mass in 174 adults. Antenatal betamethasone exposure did not. Lower birth weight and prematurity predicted reduced adult height. Slower fetal growth rather than prematurity predicted lower bone mass, but this lower bone mass was appropriate for reduced adult height. Small size at birth is reported to be associated with lower bone mass in adulthood. However, previous studies have not distinguished the relative contributions of length of gestation and fetal growth to size at birth. Fetal exposure to excess glucocorticoids has been proposed as a core mechanism underlying the associations between birth size and later disease risk. Antenatal glucocorticoids are given to pregnant women at risk for preterm delivery for the prevention of neonatal respiratory distress syndrome in their infants. We determined the relationship of antenatal exposure to betamethasone, birth weight, and prematurity to peak bone mass and femoral geometry in the adult survivors of the first randomized trial of antenatal glucocorticoids. We studied 174 young adults (mean age, 31 years) whose mothers participated in a randomized trial of antenatal betamethasone. Mothers received two doses of intramuscular betamethasone or placebo 24 h apart. Two thirds of participants were born preterm (<37 weeks gestation). We measured indices of bone mass and size and derived estimates of volumetric density and bone geometry from DXA assessments of the lumbar spine, femur, and total body. There were no differences between betamethasone-exposed and placebo-exposed groups in any of the lumbar spine, femur, or total body DXA measures. There was no effect of antenatal betamethasone on adult height, although leg length was increased relative to trunk length (p = 0.002). A lighter birth weight (p <or = 0.001) and lower gestational age (p = 0.013) were associated with shorter stature (height Z scores) at age 31 years. Prematurity had no effect on peak bone mass or femoral geometry. However, lower birth weight, independent of gestational age, was associated with lower later bone mass (p < 0.001 for lumbar spine and total body, p = 0.003 for femoral neck BMC). These effects on bone mass were related to bone size and not to estimates of volumetric density. In the femur, lower birth weight, independent of gestational age, was associated with narrowing of the upper shaft and narrow neck regions. Antenatal betamethasone exposure does not affect peak bone mass or femoral geometry in adulthood. Birth weight and prematurity predict adult height, but it is slower fetal growth, rather than prematurity, that predicts lower peak bone mass. The lower peak bone mass in those born small is appropriate for their adult height.

Objectives: Low bone mass is a common disorder in elderly population which predisposes to fracture with minimal trauma. This study was performed to find out the association between the Body Mass Index (BMI) and Bone Mineral Density (BMD) in postmenopausal women.Materials and Methods: This cross sectional study was carried out at Institute of Nuclear Medicine and Allied Sciences Comilla and Mitford, Dhaka over a period of 12 months from January 2013 to December 2013. A total 93 postmenopausal women were enrolled for this study. All postmenopausal women underwent a BMD scan of femoral neck and lumbar vertebrae using a Dual Energy X-ray Absorptiometry (DEXA). Participants were categorized into three groups according to their age and BMI. BMD were expressed base on T-score according to WHO criteria. The relation among BMI, age and BMD were assessed.Results: The results of this study showed that the mean age of the study group was 57.13±7.49 years with range of 46 to 75 years. The most postmenopausal women were in age group 55-65years. The mean BMI of the study subjects were 24.18±5.08 kg/m2 with a range of 15.62 to 36.20 kg/m2. Among 93 subjects osteopenia was greater at lumbar spine (45.2%) with T-score mean±SD-1.83±0.33 and osteoporosis at femoral neck (51.6%) with T-score mean ±SD-3.36±-0.67. Pearson’s correlation coefficient test showed inverse relationship between age and BMD both lumbar spine (r = -0.301, p = 0.003) and femoral neck (r = -0.303, p=0.003) whereas the positive relation between BMI and BMD both at lumbar spine (r=0.338, p=0.001) and femoral neck (r =0.343, p=0.001). These showed that with advancing age, BMD decreases and the risk of osteoporosis increases and with increasing BMI, BMD increases and risk of osteoporosis decreases.Conclusion: The findings of this study portrait that aging and low BMI are risk factors associated with bone loss. So preventive measure should be taken for high risk post menopausal women.Bangladesh J. Nuclear Med. 17(2): 138-141, July 2014

Different factors may contribute to the development of osteopenia or osteoporosis. Fatty acids are key nutrients for health, and a number of studies have reported an association between bone mineral density (BMD) and fatty acid intake. We aimed to investigate the relationships between serum levels of different fatty acids and bone parameters determined by quantitative bone ultrasound (QUS), peripheral quantitative computed tomography (pQCT), and dual-energy X-ray absorptiometry (DXA) in a sample of Spanish postmenopausal women. We enrolled a total of 301 postmenopausal women (median age 59 years; interquartile range (IQR) 7) in this study. All participants underwent full densitometric screening, including calcaneal quantitative ultrasound (QUS), peripheral quantitative computed tomography (pQCT), and dual-energy X-ray absorptiometry (DXA), as well as plasma fatty acid measurement. After adjustment for potential confounders, plasma n-3 polyunsaturated fatty acid (PUFA) levels correlated with BMD in the spine (r = 0.150; p = 0.014) and femoral neck (r = 0.143; p = 0.019). By multiple linear regression, an independent statistically significant positive relationship was observed between BMD in the spine and BMI (β = 0.288; p = 0.001) as well as total plasma n-3 PUFAs (β = 0.155; p = 0.009). The plasma n-3 PUFA level was also a significant and positive predictor of BMD at the femoral neck (β = 0.146; p = 0.009). Independent risk factors for low BMD (T-score ≤ 1) were determined by logistic regression analysis, and a relatively high level of plasma n-3 PUFAs (OR = 0.751; 95% CI 0.587-0.960, p = 0.022) was identified as a protective factor against low bone mass. In this single-center sample of Spanish postmenopausal women, we reported a significant positive and statistically independent association between BMD and plasma levels of n-3 PUFAs.

The LIFTMOR trial demonstrated a novel, HiRIT program notably improved bone mass in postmenopausal women with osteopenia and osteoporosis. While no clinical signs or symptoms of vertebral crush fracture were evident during the trial, anecdotal feedback suggests that concerns about safety of HiRIT in the osteoporosis demographic remain.The aim of the current work was to assess vertebral body morphology, Cobb angle, and clinical measures of thoracic kyphosis in participants in the LIFTMOR trial for evidence of vertebral fracture following 8 months of supervised HiRIT. Participants were randomized to either 8months of 30-min, twice-weekly, supervised HiRIT or unsupervised, low-intensity, home-based exercise (CON). Lateral thoracolumbar DXA scans (Medix DR, Medilink, France) were performed at baseline and follow-up. Cobb angle was determined, and vertebral fracture identification was performed using the semiquantitative Genant method. Clinical kyphosis measurements were performed in relaxed standing (neutral posture) and standing tall using an inclinometer and a flexicurve. The HiRIT group exhibited a reduction in inclinometer-determined standing tall thoracic kyphosis compared to CON (- 6.7 ± 8.2° vs - 1.6 ± 8.1°, p = 0.031). Both the HiRIT and CON groups exhibited within-group improvement in kyphosis in relaxed standing as measured by both inclinometer and flexicurve (p < 0.05). There were no changes in vertebral fracture classification in the HiRIT group post-intervention. A single, new, wedge deformity was observed for CON. Supervised HiRIT was not associated with an increased risk of vertebral fracture in postmenopausal women with low bone mass. Indeed, a clinically relevant improvement in thoracic kyphosis was observed following 8months of supervised HiRIT, further supporting its efficacy as an osteoporosis intervention for postmenopausal women with low to very low bone mass.

There are many factors which affect the fracture risk in elderly women. Among them we stress low bone mass, increased occurrence of falls, and anthropometric characteristics and physical activity. Low bone mass in postmenopausal women may come from genetic and environmental factors. The non-modifiable factors are gender and age. The modifiable ones are related to change of habits, including a sedentary lifestyle. Low bone mass is prevalent in women and the problem worsens with aging. Fractures represent a high cost in hospitalization, rehabilitation, morbidity and mortality. PURPOSE: The aim was to analyze the correlation among the history of fractures over the age of 50, physical activity and body mass index (BMI) in elderly women. METHODS: The study was approved by the Research Ethics Committee of PUCRS, Letter No. 05029/35, and the sample consisted of 284 elderly from 60 to 94 years with an average of 71.2 ± 7.8 years, who had or had not done physical activity for at least 3 months on a regular and systematic basis, with a BMI between 14.3 and 44.8. Data were analyzed using descriptive and inferential statistics (chi-square test). RESULTS: Among the 284 elderly women, 76 had a history of fractures over the age of 50, 28 of these were physically active e the other 48 were not. Also, among the 97 physically active ones, 28 women (28.9%) had fractures, 11.1% with BMI ≤ 22, 28.2% with BMI 22-27, and 32.7% with BMI ≥ 27. Among the 187 non-physically active ones, 48 women (25.7%) had a history of fractures, 22.7% of those with BMI ≤ 22, 28.3% with BMI between 22-27 and 24.8% with BMI ≥ 27. CONCLUSION: Physical activity plays a fundamental role in increasing bone mass during childhood and adolescence, and it's a necessary stimulus for one to reach his/her peak bone mass in adulthood. Some studies in postmenopausal women are inconclusive on the association between physical activity and bone mass maintenance, and others, point out that only exercise or calcium supplementation alone can not compensate for the loss of bone mass and suggest that the benefits of exercise on low bone mass works if there is a high calcium and D vitamin intake, suggesting that physical activity, D vitamin and calcium would act synergistically. This leads to the need of correlating variables related to physical activity.

The Preference and Satisfaction Questionnaire (PSQ) compares patient preference and satisfaction between a 6-month subcutaneous injection and weekly oral tablet for treatment of bone loss. Patients preferred and were more satisfied with a treatment that was administered less frequently, suggesting the acceptability of the 6-month injection for treatment of bone loss. The PSQ compares patient preference and satisfaction between a 6-month subcutaneous injection and a weekly oral tablet for treatment of bone loss. Postmenopausal women with low bone mass who enrolled in two separate randomized phase 3 double-blind, double-dummy studies received a 6-month subcutaneous denosumab injection (60 mg) plus a weekly oral placebo or a weekly alendronate tablet (70 mg) plus a 6-month subcutaneous placebo injection. After 12 months, patients completed the PSQ to rate their preference, satisfaction, and degree of bother with each regimen. Most enrolled patients (1,583 out of 1,693; 93.5%) answered >or=1 item of the PSQ. Significantly more patients preferred and were more satisfied with the 6-month injection versus the weekly tablet (P < 0.001). More patients reported no bother with the 6-month injection (90%) than the weekly tablet (62%). Patients preferred, were more satisfied, and less bothered with a 6-month injection regimen for osteoporosis.

Effects of Denosumab on Bone Mineral Density in Men Receiving Androgen Deprivation Therapy for Prostate Cancer

PurposeThe current study aimed to explore the associations of diet quality assessed by healthy eating index-2015 (HEI-2015) with risks of osteoporosis and low bone mineral density (BMD) among American postmenopausal women aged 50 years and older.MethodsPostmenopausal women aged 50 years and older in the National Health and Nutrition Examination Survey from 2007 through 2018 were included in the final sample. Analysis of variance and Rao-Scott adjusted chi-square tests were used to compare the characteristics across tertiles of HEI-2015. Univariate and multivariate weighted logistic regression models were employed to explore the associations of HEI-2015 tertiles and continuous HEI-2015 with the risks of osteoporosis and low BMD. Nonlinear dose-response associations were evaluated using weighted restricted cubic spline analyses, and the contributions of various HEI-2015 components were assessed using weighted quantile sum regression models.ResultsThe final sample included 3,421 postmenopausal women aged 50 years and older representative for approximately 28.38 million non-institutionalized U.S. postmenopausal women. Osteoporosis prevalence decreased with HEI-2015 tertiles while the prevalence of low BMD showed no significant decrease. Compared with postmenopausal women in the first tertile of HEI-2015, those with the second (OR: 0.57, 95%CI: 0.38–0.84) and third (OR: 0.48, 95%CI: 0.29–0.78) HEI-2015 tertiles were associated with reduced osteoporosis risk after multivariate adjustments, but no significant association of HEI-2015 with the risk of BMD was identified. Furthermore, similar effects were confirmed in the sensitivity analyses and subgroup analyses and interaction effects. Moreover, significant nonlinear associations were observed between HEI-2015 with osteoporosis risk, and total vegetables, refined grains and greens and beans demonstrated the strongest protective effect among HEI-2015 components against osteoporosis.ConclusionsThis study strongly suggests the significant negative associations of HEI-2015 with osteoporosis risk in American postmenopausal women. These findings highlight the importance of adherence to the dietary guidelines for Americans in reducing the risk of osteoporosis.

Postmenopausal women are at significant risk for osteoporotic fractures due to their rapid bone loss. Half of all postmenopausal women will get an osteoporosis-related fracture over their lifetime, with 25% developing a spine deformity and 15% developing a hip fracture. By 2050, more than half of all osteoporotic fractures will occur in Asia, with postmenopausal women being the most susceptible. Early management can halt or even reverse the progression of osteoporosis. Consequently, on October 31, 2020, the Taiwanese Osteoporosis Association hosted the Asia-Pacific (AP) Postmenopausal Osteoporotic Fracture Prevention (POFP) consensus meeting, which was supported by the Asian Federation of Osteoporosis Societies (AFOS) and the Asia Pacific Osteoporosis Foundation (APOF). International and domestic experts developed ten applicable statements for the prevention of osteoporotic fractures in postmenopausal women with low bone mass or osteoporosis but no fragility fractures in the AP region. The experts advocated, for example, that postmenopausal women with a high fracture risk be reimbursed for pharmaceutical therapy to prevent osteoporotic fractures. More clinical experience and data are required to modify intervention tactics.

Osteoporosis affects millions of people in the whole world and brings about far-reaching physical and psycho-social consequences for patients and financial ones for the health care system, and therefore it is classified as one of public health problems and treated as a social disease. Women belong to the increased osteoporosis illness risk group due to lower top bone mass reached earlier in life as compared to men and due to hormonal changes occurring in the menopausal period, which affect loss of the bone mineral density (BMD). Limitation of the osteoporosis-related financial and social costs increase requires efficient preventive actions on the level of early, primary, secondary or tertiary prevention. At all the four osteoporosis prevention phases, the crucial role is played by health education and nutrition education, the latter being the key element of the former one. The nutritional education purpose is to acquaint patients with nutrition recommendations that are the basic element of the osteoporosis prevention and to make them change their nutrition habits, which will improve their osseous metabolism. The education should be based on results of the latest scientific researches and focus on recommendations relating to proper supplementing of calcium and vitamin D, simultaneously including all the other nutrition components, necessary to decrease the osteoporosis risk. The primary prevention oriented to a specific group at risk for osteoporosis, including peri- or postmenopausal women, should be provided in cooperation with the different levels’ medical professionals and it should focus on causing positive changes in patients both as regards nutrition habits and physical activities.