Osteoporosis In Clinical Practice Research Articles

Characterizing the assessment and management of vitamin d levels in patients with osteoporosis in clinical practice: a chart review initiative.

Though vitamin D is important for bone health, little is known about the monitoring and management of vitamin D levels in patients with osteoporosis in clinical practice—a deficit this chart review initiative aimed to remedy. A total of 52 physicians completed profiles for 983 patients being treated for osteoporosis between November 2008 and April 2009. Information collected included demographics; fracture risk factors; availability and level of serum vitamin D measurements; and information on osteoporosis medications and calcium and vitamin D supplementation. Physicians also evaluated patients' current regimens and detailed proposed changes, if applicable. Nearly 85% of patients were prescribed calcium and vitamin D supplements. Serum 25-hydroxy vitamin D levels were available for 73% of patients. Of these patients, approximately 50% had levels less than 80 nmol/L, which contrasts with the 37% thought to have “unsatisfactory” vitamin D levels based on physician perceptions. Physicians felt 26% of patients would benefit from additional vitamin D supplementation. However, no changes to the osteoporosis regimen were suggested for 48% of patients perceived to have “unsatisfactory” vitamin D levels. The results underscore the importance of considering vitamin D status when looking to optimize bone health.

Adherence to treatment with denosumab, its efficacy and safety in women with postmenopausal osteoporosis in clinical practice

Adherence to treatment with antiosteoporotic drugs is one of the most important factors contributing to their efficacy during longterm therapy. The adherence is assessed by two main lines: firstly, how long a drug is taken and, secondly, whether its dosage regimen is adhered. Subjects and methods. The paper gives the data of a 12-month prospective follow-up study of 40 women with postmenopausal osteoporosis (OP) who initiated treatment with the biological agent denosumab. Results and discussion. After the 12-month follow-up, the significant bone mineral density increase was 4.9% in the lumbar spine, 3.2% in the femoral neck, and 3.0% in the total hip. The previous administration of other antiosteoporotic drugs did not lower the efficiency of denosumab therapy. There were no cases of osteoporotic fractures during 1-year follow-up. 95% of the patients received two denosumab injections (an annual cycle); moreover, 90% of the women were noted to adhere to the dosage regimen. Age, marital status, level of education, time taken to reach the clinic, parental femoral fractures, a history of fractures, duration of OP, and previous therapy had no impact on treatment adherence during 12 months. Conclusion. The one-year prospective follow-up study of the outpatients demonstrated that denosumab was an effective and safe agent for the treatment of patients with postmenopausal OP and its dosage regimen implying its rare subcutaneous administration (twice yearly) ensured the high patient adherence to therapy.

AB0805 Educational programs for patients with osteoporosis in clinical practice.

BackgroundAn effective and long-term treatment of osteoporosis is not possible without the active, regular participation of the patient in the process, which requires educational programs.ObjectivesTo evaluate the effectiveness of educational...

Grouped penalization estimation of the osteoporosis data in the traditional Chinese medicine

Both continuous and categorical covariates are common in traditional Chinese medicine (TCM) research, especially in the clinical syndrome identification and in the risk prediction research. For groups of dummy variables which are generated by the same categorical covariate, it is important to penalize them group-wise rather than individually. In this paper, we discuss the group lasso method for a risk prediction analysis in TCM osteoporosis research. It is the first time to apply such a group-wise variable selection method in this field. It may lead to new insights of using the grouped penalization method to select appropriate covariates in the TCM research. The introduced methodology can select categorical and continuous variables, and estimate their parameters simultaneously. In our application of the osteoporosis data, four covariates (including both categorical and continuous covariates) are selected out of 52 covariates. The accuracy of the prediction model is excellent. Compared with the prediction model with different covariates, the group lasso risk prediction model can significantly decrease the error rate and help TCM doctors to identify patients with a high risk of osteoporosis in clinical practice. Simulation results show that the application of the group lasso method is reasonable for the categorical covariates selection model in this TCM osteoporosis research.

Evaluation of urinary N-telopeptide of type I collagen measurements in the management of osteoporosis in clinical practice

We measured urinary N-telopeptide of type I collagen (U-NTX) to monitor response to bisphosphonates for osteoporosis. Decrease in U-NTX was associated with increase in spine bone density. A lesser response in U-NTX was more likely in those with secondary osteoporosis or with poor compliance. U-NTX may be a useful early indicator of treatment non-compliance or secondary osteoporosis. This study aims to determine the utility of the bone resorption marker, U-NTX, in the clinical setting, to monitor the response to bisphosphonate therapy (alendronate and risedronate) for osteoporosis. A retrospective evaluation of data collected as part of the bone turnover marker monitoring service in the Metabolic Bone Centre, Sheffield, UK. Treatment compliance, underlying causes of osteoporosis, change in U-NTX/creatinine (Cr) at 4 months and change in spine and hip bone mineral density (BMD) by dual-energy X-ray absorptiometry were recorded. Treatment response was defined as either a change in U-NTX/Cr greater than a pre-defined least significant change (LSC) of 54 % or to within the lower half of a pre-defined pre-menopausal reference interval (≤ 30 nM BCE/mmol Cr). A greater decrease in U-NTX/Cr at 4 months was associated with a greater increase in spine BMD at 18 months (r = -0.33; P < 0.0001, Pearson's correlation). The mean U-NTX/Cr at 4 months was higher in patients with secondary osteoporosis compared with those with primary osteoporosis (P < 0.01, ANOVA). A lesser response in U-NTX/Cr increased the likelihood of secondary osteoporosis or poor treatment compliance (P = 0.04, Fisher's exact test). A lack of response in U-NTX/Cr to within the lower half of the reference interval was a better indicator of secondary osteoporosis and treatment non-compliance than a change in U-NTX/Cr greater than LSC. Treatment monitoring using U-NTX/Cr has a place in clinical practice for the early identification of non-compliance or presence of secondary osteoporosis.

Oral bisphosphonates reduce the risk of clinical fractures in glucocorticoid-induced osteoporosis in clinical practice

This study aims to estimate bisphosphonate effectiveness by comparing fracture incidence over time on therapy in glucocorticoid-induced osteoporosis (GIO). From this observational study, alendronate and risedronate decreased clinical vertebral and nonvertebral fractures over time. The effectiveness of each bisphosphonate is consistent with their efficacies demonstrated on surrogate markers in randomized controlled trials (RCTs). This study aims to estimate bisphosphonate effectiveness by comparing fracture incidence over time on therapy with fracture incidence during a short period after starting a therapy. The study population was a subgroup of a larger cohort study comprising two cohorts of women aged ≥65years, prescribed with alendronate or risedronate. Within the two study cohorts, 11,007 women were identified as having received glucocorticoids. Within each cohort, the baseline incidence of clinical fractures at nonvertebral and vertebral sites was defined by the initial 3-month period after starting therapy. Relative to these baseline data, we then compared the fracture incidence during the subsequent 12months on therapy. The baseline incidence of clinical nonvertebral and vertebral fractures was similar in the alendronate cohort (5.22 and 5.79/100 person-years, respectively) and in the risedronate cohort (5.51 and 5.68/100 person-years, respectively). Relative to the baseline incidence, fracture incidence was significantly lower in the subsequent 12months in both cohorts of alendronate (33% lower at nonvertebral sites and 59% at vertebral sites) and risedronate (28% lower at nonvertebral sites and 54% at vertebral sites). From this observational study not designed to compare drugs, both alendronate and risedronate decreased clinical vertebral and nonvertebral fractures over time. The reductions observed in fracture incidence, within each cohort, suggest that the effectiveness of each bisphosphonate in clinical practice is consistent with their efficacies demonstrated on surrogate markers in randomized controlled trials.

Quantitative Ultrasound Measurements at the Calcaneus in a Population of Urban Senegalese Women: Least Significant Difference and T-Score

Background: Bone ultrasound measurements can be used to evaluate osteoporosis in clinical practice. As with DXA, ultrasonography shows marked variations across racial groups. In the USA, quantitative ultrasound measures were higher in African-American women than in Caucasian women. Few data are available on these measures in African women, and there are no normative data for Senegalese women. Our objectives were to evaluate the least significant difference (LSD) and to establish reference values of quantitative ultrasound measures at the calcaneus in Senegalese women. Methods: Reference values were obtained in 50 healthy women aged 25-35 years. A UBIS 5000 ultrasound sonometer was used to determine speed of sound (SOS), broadband ultrasound attenuation (BUA), and the Strength Index (STI) at both heels. Results: In the 50 healthy controls (mean age, 29.8 ± 3.7 years, mean height, 167.3 ± 5.8 cm, mean weight 68.1 ± 13.2 kg; 38 right-handed), BUA (mean of the two sides) was 72.24 ± 6.83 dB/MHz. BUA values were higher in women with regular sporting activities (n=10) and in those with higher body weight values, indicating an increase in bone mass associated with greater loads through the calcaneus. Conclusion: Quantitative ultrasound parameters measured at the calcaneus using a UBIS 5000 sonometer in Senegalese women showed similar reproducibility to that reported previously in Caucasian women examined using the same sonometer or a comparable sonometer. The mean BUA values in our reference population can be used to compute T-scores in individual female patients in Senegal. Our data support a link between greater mechanical loads and higher bone mass.

Defining High Risk of Osteoporotic Fracture

: There is no universally accepted definition for patients at high risk of osteoporotic fracture. : This study aimed to survey Spanish rheumatologists; to obtain opinions about risk factors, and an acceptable definition for patients at high risk of osteoporotic fracture; and to compare daily practice patterns with current osteoporosis guidelines. : A total of 174 rheumatologists from throughout Spain completed an online survey about various risk factors for fragility fracture and about the management of patients with osteoporosis in clinical practice. Results were reviewed by a coordinating committee of osteoporosis experts and were compared with published national and international guideline recommendations. : Almost all rheumatologists who completed the survey (99%) consider that a group of patients exists with a high risk of osteoporotic fracture and that this group should be managed appropriately. Previous fracture is considered the most important risk factor, particularly in cases of multiple fracture, severe vertebral fracture, hip fracture, or fracture despite osteoporosis treatment. However, in osteoporosis guidelines, age, bone mineral density, and previous fragility fracture are the most important risk factors for new fracture. Furthermore, Spanish rheumatologists tend to treat patients at high risk of fracture with anabolic therapy (e.g., teriparatide), whereas guidelines make no such recommendation. : In osteoporosis, a large gap exists between implementation of guideline recommendations and actual clinical practice; this may be due, in part, to heterogeneity among existing guidelines. Thus, inclusion in guidelines of a practical definition of high risk of osteoporotic fracture may provide significant opportunities to improve patient care and prevent future fragility fractures. :

Evaluation of FRAX as a screening tool to predict or exclude the presence of osteoporosis in clinical practice

Evaluation of FRAX as a screening tool to predict or exclude the presence of osteoporosis in clinical practice

Pharmacological therapy of osteoporosis

Osteoporosis is a disease associated with an increased risk of fractures. Vertebral and hip fractures are associated with high mortality or loss of autonomy. The aim of this review is to explore the scientific evidence for current therapies for postmenopausal osteoporosis and fractures and to establish how to treat osteoporosis in clinical practice without risk for patients. We performed research by the use of pubmed of all randomized controlled trials on osteoporosis therapy. The key works used were “osteoporosis therapy”; “postmenopausal osteoporosis” and “osteoporosis trial”. Efficacious pharmacological therapy include alendronate, risedronate, hormone replacement therapy, strontium ranelate, that are successful agents for femoral and vertebral sites. All osteoporosis patients may take calcium and vitamin D supplementation often not recommended by the physicians. Treatment of Osteopenic patients need further evidence. Early diagnosis and treatment can help to reduce the complications such as fractures but adverse effects may be monitoring and need particular knowledge in this setting [1-4].

Design of a pragmatic approach to evaluate the effectiveness of concurrent treatment for the prevention of osteoporotic fractures

The aim of osteoporosis treatment is to prevent future fractures. Although concurrent treatment has been used very frequently for osteoporosis in clinical practice, there are no data on accurate and verified effectiveness of concurrent treatment for fracture prevention in patients with osteoporosis. To clarify the clinical usefulness of concurrent treatment, the Japan Osteoporosis Society has authorized the establishment of the A-TOP (Adequate Treatment of Osteoporosis) research group. The objective of this research is to establish a design for a clinical trial to prove whether concurrent treatment using both alfacalcidol (1-alpha-hydroxycholecalciferol) and alendronate is more effective as compared to treatment using alendronate alone in terms of fracture prevention. The present study was named JOINT (Japanese Osteoporosis Intervention Trial) and is based on a method using national, prospective, randomized, open-labeled, blinded endpoints focusing on postmenopausal osteoporosis with a high risk for fracture. The patients were mainly selected by practitioners and allocated randomly by a central registration system into two groups, of which one received 5mg/day of alendronate alone, and the other received 1μg/day of 1-alpha-hydroxycholecalciferol (alfacalcidol) in addition to the alendronate. The endpoints focused primarily on fracture prevention, and the patients' quality of life (QOL) and change in body height, as well as adherence and the adverse events of the treatments were evaluated secondarily. To obtain sufficient statistical power in the events during a 2-year observation period, the patients who are expected to have higher risk were selected to participate in this study, and it was decided that the final plan would involve 890 patients per group (two-sided alpha=0.05, power=0.8). Data collection began in November 2003. Correspondence regarding the registration of the investigator and the progress of the study was conducted through a web system from the Public Health Research Foundation to practitioners.

Benefits and Limitations of Bone Mineral Density and Bone Turnover Markers to Monitor Patients Treated for Osteoporosis

Medications are approved by regulatory agencies for treating osteoporosis when at least one randomized placebo-controlled clinical trial shows a reduction in vertebral fracture risk and the benefit-risk ratio is determined to be acceptable. Subjects who participate in registration trials are a generally homogeneous group carefully screened with strict entry criteria. Individual patients who are treated for osteoporosis in clinical practice commonly differ from subjects enrolled in these clinical trials according to confounding factors that include age, sex, comorbidities, compliance, and persistence. Because the goal of therapy is reduction of fracture risk, and this cannot be directly assessed in an individual patient, biomarkers are commonly used as surrogate end points for effectiveness. This article reviews the clinical use and abuse of the two biomarkers most commonly used to assess the effectiveness of therapy in clinical practice: bone mineral density testing and measurement of markers of bone turnover.

The prevention and treatment of glucocorticoid-induced osteoporosis in clinical practice

Glucocorticoids are associated with increased risk of bone loss and fracture. This study compared the prescribing of bone protective agents by rheumatologists in clinical practice with the standards recommended in the 1998 UK Consensus guidelines. All glucocorticoid users who attended rheumatology outpatients during a four-week period were eligible. Notes were audited according to a predefined proforma. Among the 1290 rheumatology outpatients seen in the study period, 189 (15%) were taking glucocorticoids. 63% of glucocorticoid patients were taking calcium and 46% vitamin D. In total, 124 (71%) of the 175 patients available for review were at high risk of osteoporotic fracture, of whom 76 (61%) were taking appropriate prophylaxis. In 26 (15%) patients, insufficient information was available to be able to quantify the risk of fracture. The study showed that the audit standard was not met in 39% of cases. A better strategy for the monitoring of clinical risk factors is therefore required.

Compliance and satisfaction with raloxifene versus alendronate for the treatment of postmenopausal osteoporosis in clinical practice: An open-label, prospective, nonrandomized, observational study

Background: The treatment of osteoporosis among postmenopausal women represents a major public health challenge because long-term therapy is needed to prevent fractures and chronic disability. Low patient compliance with prescribed osteoporosis treatments can severely distort the validity of controlled clinical trials. Raloxifene and alendronate have been shown to reduce the incidence of osteoporotic fracture in postmenopausal women in well-conducted randomized trials, but few data are available on the rate of adherence to these treatments in routine clinical practice. Objective: The primary aim of this study was to assess the compliance of postmenopausal women at risk for osteoporotic fractures who were treated with raloxifene hydrochloride (RLX) versus alendronate sodium (ALN) during a 12-month observational period in a routine clinical setting. Secondary objectives were the assessment of factors that might contribute to noncompliance and patient satisfaction. Methods: This open-label, prospective, multicenter, nonrandomized, observational, comparative study was conducted at 154 centers across Spain. Assignment to either RLX or ALN treatment was determined by the physician and was based on each patient's clinical profile. Compliance with RLX (60-mg tablet once daily) versus ALN (10-mg tablet once daily) was assessed using 3 different compliance assessment tools: the Morisky-Green test, the Autocompliance test, and the Compliance Questionnaire. A logistic regression model was used to assess different factors affecting compliance. Patient satisfaction was also assessed using a questionnaire. Adverse events (AEs) were collected as reasons for discontinuation in the Compliance Questionnaire and at the discontinuation visit. Results: A total of 902 women (RLX group, n = 476; ALN group, n = 426) were included in the study (mean age, 64.4 [6.9] years). Overall, patients in the RLX group reported significantly better compliance than patients in the ALN group, as collected either by the Morisky-Green test (68.7% vs 54.0%; P < 0.001) or the Autocompliance test (94.7% vs 90.6%; P = 0.033). More patients discontinued treatment prematurely in the ALN group compared with the RLX group (25.8% vs 16.4%; P < 0.001). The age-adjusted relative risk for discontinuation was 1.4-fold higher for women treated with ALN than for those treated with RLX (95% CI, 1.21-1.61). The main reason for premature discontinuation was due to AEs (RLX 4.8% vs ALN 11.0%; P < 0.001). The proportion of patients with gastrointestinal AEs was 9.9% in the ALN group and 3.4% in the RLX group ( P < 0.001). Only treatment and type of physician were independent covariates of treatment compliance. After 12 months of observation, significantly more patient in the RLX group were satisfied or very satisfied with their treatment than patients in the ALN group ( P < 0.001). Conclusion: In this study of postmenopausal women at risk for osteoporotic fractures, compliance with 12-month treatment with daily RLX was higher than with daily ALN in clinical setting. RLX showed significant benefits compared with ALN in terms of compliance assessed by means of the Morisky-Green and Autocompliance tests and the patients' self-reported satisfaction.

Diagnosis of osteoporosis in clinical practice

Measurement of bone mineral density is the basis of the diagnosis of osteoporosis. The risk of fracture increases with decreasing bone mineral density, which can be measured using several different techniques. Dual energy x-ray absorptiometry is the most commonly used technique today. A further facility of the new bone densitometry technology is the option for vertebral morphometry. There are errors of accuracy in all bone densitometry techniques and also in the interpretation of the data they provide. Ultrasound of bone may provide new measures of bone fragility. Broadband ultrasound attenuation of the calcaneus predicts the risk of hip fracture in elderly women almost or equally as well as bone densitometry. Ultrasound does not expose to radiation and the equipment is portable. However, bone ultrasound cannot replace bone densitometry. Biochemical bone markers do not differentiate osteoporotic patients from healthy adults. However, they can be useful in deciding on interventions and in monitoring the efficacy of treatment. Their predictive value in individuals suffers from large variability. Biochemistry is widely used in the differential diagnosis of secondary osteoporosis. Suspicion of osteomalacia or an invasive process in the bone marrow are the most common indications for bone biopsy. Finally, although history and physical examination are insufficient in diagnosing primary osteoporosis, they are important in targeting other investigations to exclude secondary forms of osteoporosis.

The measurement of osteoporosis in clinical practice

It has been reported that metacarpal morphometry does not correlate with iliac crest histomorphometry in patients with hip fractures. Such disagreement led us to study the correlation between both types of measurements on 35 patients who had suffered hip fracture. We observed a significant correlation between metacarpal morphometry and iliac crest cortical width (p less than 0.001), and to a lesser degree with the trabecular bone volume (p less than 0.01). The same was also true if we assessed separately the patients with cervical or trochanteric hip fractures.

Osteoporosis: Osteoporosis in clinical practice.

Osteoporosis: Osteoporosis in clinical practice.