Comparison of bone mineral density of osteoporotic and osteopenia menopausal women treated with oral bisphosphonates before stopping the treatment and 1 year after drug holiday period.

BACKGROUND: Osteoporosis is a skeletal and bone disorder characterized by bone fractures and decreased bone mineral density (BMD). Bisphosphonates have a great tendency to bind to minerals, and their long-term use can increase the risk of bone fragility in patients. Stopping bisphosphonates after a period of time is called a drug holiday (DH). Recent evidence has shown that patients' BMD may decrease again during DH. However, few studies have been done in this regard. In the present study, we compared the BMD of postmenopausal women during bisphosphonates treatment and 1 year after DH. MATERIAL AND METHODS: A total of 202 patients were selected with osteopenia (n = 95) and osteoporosis (n = 107); they had been treated with alendronate for 5 years (a rheumatologist confirmed the diagnosis of osteopenia and osteoporosis) and had undergone DH for 1 year. At the arrival of all patients, BMD was checked with the DXA (dual-energy X-ray absorptiometry) method using the 2007 American Explorer model Hologic device based on the Caucasian race. One year later, patients were reassessed for BMD by the same device. RESULT: The analysis of femoral neck (FN) and lumbar spine (LS) T-score indices in the osteopenia and the osteoporosis groups showed reduction after DH, and the difference was statistically significant in both groups (p = 0.001). After 1 year of stopping bisphosphonate treatment, the average of FN and LS BMD decreased in both groups (p = 0.001). CONCLUSION: In general, it can be said that DH can reduce FN and LS T-scores. The results indicated a significant reduction in BMD after the DH period for both the osteoporosis and osteopenia groups in the early months. Also, the effect of DH in osteoporosis patients was more compared to the osteopenia individuals, which could have implications for their treatment approach, and also its effect on bone health. Key Points • The DH can reduce FN and LS T-scores • The BMD reduced after the DH period for both the osteoporosis and osteopenia groups • After 1 year of stopping bisphosphonate treatment, the average of FN and LS BMD decreased in both groups.

A Phase IV Study of the Safety and Efficacy of CinnoPar® in Iranian Patients with Osteoporosis.

The safety of teriparatide has been studied in various phase III and phase IV trials. However, a postmarketing study of the biosimilar of teriparatide, CinnoPar®, has not been conducted on Iranian patients. This was a phase IV study conducted on osteoporotic patients who received an Iranian teriparatide biosimilar with a dose of 20 µg daily. The primary outcome of this study was to monitor for adverse events (AEs). Effectiveness as the secondary outcome was measured using the EQ-5D quality-of-life questionnaire and back pain Visual Analogue Scale (VAS) score. Among 193 analyzed patients between September 2015 and March 2019, the most common AEs were hypercalcemia (4%), nausea, and pain (3%). No deaths, serious AEs, or other significant AEs occurred in this study. The mean EQ-5D scores decreased after the course of the treatment from 2.3 ± 0.66 at the baseline to 2 ± 0.66. The mean back pain VAS scores also decreased from 4.9 ± 3.6 at baseline to 1.8 ± 2.1 at the end of the study. Both changes were statistically significant (p < 0.001). Consistent with the findings of previous studies and the drug monograph, no new safety concern was observed with this biosimilar teriparatide, and the drug was effective based on the VAS score and EQ-5D in osteoporotic patients.

Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): A Multicenter Post-marketing Surveillance Study.

INTRODUCTION: Phase IV post-marketing surveillance studies are needed to evaluate the real-world safety and effectiveness of drug products. This study aimed to evaluate the safety and effectiveness of biosimilar etanercept (Altebrel, AryoGen Co., Iran) in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA). METHODS: In this open-label, multicenter, prospective, observational, post-marketing surveillance study, 583 patients received biosimilar etanercept 25 mg twice weekly or 50 mg once weekly and were followed up to 12 months. The primary objective was to evaluate the safety of biosimilar etanercept by documenting all the adverse events in the case report forms throughout the study period. The secondary objective was to evaluate the effectiveness of biosimilar etanercept in study patients, where longitudinal changes in health assessment questionnaire (HAQ), pain, and disease activity scores were assessed. RESULTS: A total of 583 patients (44.80 ± 13.09 years of age) were included and followed for an average of 8.12 ± 3.96 months. Among all patients, 172 (29.50%) experienced at least one adverse event, and injection site reaction, abdominal pain, and upper respiratory tract infection were the most common. HAQ scores decreased from 1.32 ± 0.77 at baseline to 0.81 ± 0.61 at 12 months in patients with RA/PsA (p < 0.01) and from 0.82 ± 0.58 at baseline to 0.66 ± 0.63 at 12 months in patients with AS (p = 0.18). Pain scores decreased from 6.49 ± 2.41 at baseline to 3.51 ± 2.39 at 12 months (p < 0.01). CONCLUSION: The results demonstrated the real-world safety and effectiveness of biosimilar etanercept in patients with RA, PsA, and AS. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT04582084.

Effects of Levothyroxine and thyroid stimulating hormone on bone loss in patients with primary hypothyroidism.

OBJECTIVE: Previous studies on bone mineral density (BMD) abnormalities associated with hypothyroidism are scarce and not conclusive. The effect of thyroid hormone therapy on BMD has shown mixed results. The aim of the present study was to determine the severities of osteoporosis in female patients with hypothyroidism in comparison to healthy women. METHODS: This cross-sectional descriptive study was performed on 150 women aged over 50 years. Totally, 100 patients with primary hypothyroidism and 50 healthy subjects were enrolled in this study and divided into three groups. Group A, which consisted the patients who had been recently diagnosed with primary hypothyroidism. The second group of patients diagnosed with primary hypothyroidism for at least 2 years and was treated with levothyroxine (Group B). The third group of healthy individuals was selected as a control group (Group C). Blood samples were taken for the measurements of thyroid stimulating hormone (TSH), and bone densitometry was performed to determine the BMD reported as T-score in order to measure the severity of osteoporosis. T-score of the lumbar vertebra (L2-L4) and femoral neck were measured with dual energy X-ray absorptiometry and were compared between the three groups. Data were analyzed by SPSS using regression analysis and Mann-Whitney, Kruskal-Wallis, or analysis of variances statistical tests. The statistical significance was set at a P < 0.05. FINDINGS: The average age of patients and baseline serum TSH levels in Group B was significantly different from the other two groups (P < 0.001). T-score of the lumbar spine (L2-L4) in Group B was significantly lower than the other groups (P = 0.01). The linear regression between serum TSH levels and BMD categories were not clearly associated. However, after removing the effect of the baseline TSH level in Group B, bone loss was significantly greater than the other two groups (P = 0.01). CONCLUSION: According to the present study, it seems that the treatment of hypothyroidism with thyroid hormones reduces both serum levels of TSH and bone density. Hence, proper control of this risk factor can be an effective way in prevention of osteoporosis.

Evaluation of bone loss in diabetic postmenopausal women.

BACKGROUND: Osteoporosis and diabetes mellitus are major and growing public health problems particularly among postmenopausal women. This study was conducted to evaluate the relationship between osteoporosis and osteopenia with type 2 diabetes mellitus (DM) in postmenopausal women. MATERIALS AND METHODS: In a cross sectional study, we compared 200 diabetic postmenopausal women with 400 non-diabetic postmenopausal women over the age of 60 years. Age, Body Mass Index (BMI), T score of the lumbar vertebra (L2-L4) and femoral neck were measured with Dual Energy X-ray Absorptiometry (DXA) and were compared between the two groups. Hemoglobin A1C (HbA1C) was also measured in patients with type 2 DM and its relationship with osteoporosis was studied. Chi-square, Fisher's exact test and Independent T-test was used for analyzing the data. The statistical significance was set at a P value of 0.05 or lower. RESULTS: Mean, SD ages were 65.23 ± 4.80 vs. 66.91 ± 5.78 years and BMI were 28.94 ± 4.06 vs. 31.65 ± 4.42 kg/m(2) in non-diabetic and diabetic groups, respectively. Lumber T scores was -2.10 ± 1.08 vs.-2.16 ± 1.27 (P = 0.60), femoral neck T-score was -0.72 ± 1.00 vs. -1.09 ± 0.96 (P = 0.00) in non-diabetic and diabetic groups, respectively. There was a significant difference in femoral neck T score between the diabetic and non-diabetic group (P = 0.00). In diabetic women, bone loss was more common in those with HbA1C ≥7 compare to those with HbA1C <7 (P = 0.006). CONCLUSION: Osteopenia and osteoporosis is more common in diabetic postmenopausal women compare to the non-diabetic postmenopausal women.

Health-related quality of life and disease activity in rheumatoid arthritis.

BACKGROUND: The present study sought to 1) investigate the degrees of correlations between different disease activity scores (DASs) and health-related quality of life (HRQoL), and 2) determine if DASs correlate with either physical or mental HRQoL. METHODS: Eighty patients with rheumatoid arthritis (RA) were assessed for different DASs, measured with erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), namely DAS4-ESR, DAS-3 ESR, DAS4-CRP, DAS3-CRP, DAS4-28 ESR, DAS3-28 ESR, DAS4-28 CRP, and DAS3-28 CRP, and Simplified Disease Activity Indexes namely SDAI-ESR, and SDAI-CRP. Physical and mental HRQoL were measured using the SF-36. The Pearson correlation test was employed to examine the correlations between HRQoL and different DAS indices. PASS 2000 (Power Analysis and Sample Size) software was utilized to find significant differences between the correlations. RESULTS: SF-36 total score showed a significant inverse correlation with the DAS4-ESR, DAS-3 ESR, DAS4-CRP, DAS3-CRP, DAS4-28 ESR, DAS3-28 ESR, DAS4-28 CRP, and DAS3-28 CRP, with correlation coefficients of -0.320, -0.314, -0.330, -0.323, -0.327, -0.318, -0.360 and -0.348, respectively (P < 0.01 for all). The correlation coefficients between different DAS indices and the HRQoL score were not significantly different. In addition, all DASs showed significant correlations with physical HRQoL, but not with mental HRQoL. CONCLUSIONS: Among patients with RA, disease severity indices are associated with physical, but not mental HRQoL. However this study failed to show any differences between various DASs in their clinical use.

Effect of ethnic origin (Caucasians versus Turks) on the prevalence of rheumatic diseases: a WHO-ILAR COPCORD urban study in Iran.

The objective of this study was to compare the prevalence of musculoskeletal complaints and rheumatic disorders in Caucasians and Turks in an identical environment. Subjects were selected randomly for an interview from Tehran's 22 districts. The Community Oriented Program for Control of Rheumatic Diseases questionnaire was filled in, positive cases were examined, and if needed, laboratory or X-ray tests were performed. A total of 4,096 houses were visited, and 10,291 persons were interviewed. They were 71.4% Caucasians and 23.1% Turks with similar distribution of age and gender. Musculoskeletal complaints of the past 7 days were detected in 40.8% of Caucasians and 45.5% of Turks (p < 0.001). In Caucasians, the total of musculoskeletal complaints in men was 33.8% (95% CI, 31.4-36.2%) versus 48.3% in women (95% CI, 45.7-50.8%). In Turks, the total of musculoskeletal complaints in men was 36.6% (95% CI, 32.2-41.1%) versus 55.8% in women (95% CI, 55.8-60.6%). The data of Caucasians versus Turks were as follows: knee pain 20.2% (95% CI, 18.2-22.1) versus 24.1% (95% CI, 20.5-27.6), with p < 0.001; dorso-lumbar spine pain 15.1% (95% CI, 13.6-16.6) versus 18.4% (95% CI, 15.1-21.8), with p < 0.001; shoulder pain 10.7% (95% CI, 9.4-11.9) versus 12.3% (95% CI, 9.7-14.8), with p = 0.025; osteoarthritis 14.1% (95% CI, 12.8-15.2) versus 16.4% (95% CI, 14.3-18.6), p = 0.04; and knee osteoarthritis 12.3% (95% CI, 11.8-14.1) versus 15.3% (95% CI, 13.3-17.4), with p < 0.001). There were no significant differences regarding the prevalence of soft tissue rheumatism, rheumatoid arthritis, ankylosing spondylitis, Behcet's disease, fibromyalgia, and gout. Although musculoskeletal complaints were more frequent in Turks than in Caucasians, the prevalence of rheumatic disorders was rather similar except for knee osteoarthritis.

WHO-ILAR COPCORD Study (Stage 1, Urban Study) in Iran.

OBJECTIVE: To find the prevalence of musculoskeletal complaints and rheumatic disorders in Iran. METHODS: Tehran, with one-ninth of the population of Iran and of mixed ethnic origins, was selected as the field. Subjects were randomly selected from the 22 districts. Interviews were conducted once a week, on the weekend. The 3 phases of stage 1 were done on the same day, in parallel, like the fast-track Community Oriented Program for Control of Rheumatic Diseases (COPCORD). RESULTS: Four thousand ninety-six houses were visited and 10,291 persons were interviewed. Musculoskeletal complaints during the past 7 days were detected in 41.9% of the interviewed subjects. The distribution was: shoulder 14.5%, wrist 10%, hands and fingers 9.4%, hip 7.1%, knee 25.5%, ankle 9.8%, toes 6.1%, cervical spine 13.4%, and dorsal and lumbar spine 21.7%. Degenerative joint diseases were detected in 16.6% of subjects: cervical spondylosis 1.8%, knee osteoarthritis (OA) 15.3%, hand OA 2.9%, and hip OA 0.32%. Low back pain was detected in 15.4% and soft tissue rheumatism in 4.6%. Inflammatory disorders were rheumatoid arthritis 0.33%, seronegative spondyloarthropathies 0.23%, ankylosing spondylitis 0.12%, systemic lupus erythematosus 0.04%, and Behçet's disease 0.08%. Fibromyalgia was detected in 0.69% and gout in 0.13% of the studied population. CONCLUSION: The large urban COPCORD study in Iran showed a high prevalence of rheumatic complaints in the population over the age of 15 years, 41.9%. Knee OA and low back pain were the most frequent complaints.

The prevalence of oral aphthosis in a normal population in Iran: a WHO-ILAR COPCORD study.

This study was conducted to determine the prevalence of oral aphthosis in a normal population in Iran, using the data of the WHO-ILAR COPCORD study in Iran. We conducted this study in Tehran, the capital of Iran which was selected as the COPCORD study field. In 22 districts of Tehran, 50 clusters were randomly selected. Of the selected houses, 4,096 households were visited and 10,291 persons were interviewed (response rate of 75%). Out of the 10291 subjects interviewed, 2592 had aphthous ulcers which translated to a prevalence of 25.2% (95% confidence interval: 24.4% to 26.0%). The prevalence of oral aphthosis was rather high in this normal population.