Evaluation of Bone Mineral Density, Serum Osteocalcin, and Osteopontin Levels in Postmenopausal Women with Type 2 Diabetes Mellitus, with/without OsteoporosisRead the full article
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Characteristics Associated with Acute-Phase Response following First Zoledronic Acid Infusion in Brazilian Population with Osteoporosis
We aimed to evaluate characteristics associated with acute-phase response (APR) following first zoledronic acid infusion in a Brazilian cohort. This retrospective cohort study enrolled all adults with osteoporosis who underwent a first zoledronic acid infusion at our centre between June 2015 and June 2019. Clinical demographics (age, sex, diabetes, smoking, body mass index, and previous oral bisphosphonate use) and laboratory data (calcium, parathyroid hormone, renal function, and serum 25-hydroxyvitamin D and carboxy-terminal crosslinked telopeptide of type 1 collagen [CTX], both before and after infusion) were compared between patients with and without APR. We evaluated association magnitude between the presence of APR and clinical variables through logistic regression. This study enrolled 400 patients (women, 80%). APR was observed in 24.5% (n = 98) of patients. The mean symptom duration in days was 3.5 ± 2.8. Patients with APR were younger (67 ± 12 vs. 71 ± 11 years; ), used oral bisphosphonates less frequently (34% × 50%; ), and had greater baseline CTX (0.535 ng/mL [0.375, 0.697] × 0.430 [0.249, 0.681]; ) and ΔCTX (−69 [−76; −50] × −54 [−72; −23]; ) than those without APR. The other variables were similar between the groups. Only ΔCTX was associated (OR, 0.62; 95% CI 0.41–0.98) with APR after accounting for age and bisphosphonate use. APR occurred in 24.5% of the cohort. Younger age and absence of prior oral bisphosphonate use were associated with APR following first zoledronic acid infusion. APR was associated with ΔCTX (but no other variables) after adjusting for these factors.
Treatment of Glucocorticoid-Induced Osteoporosis and Risk Factors for New Vertebral Fractures in Female Patients with Autoimmune Diseases
We aimed to evaluate the compliance of physicians with the 2014 guidelines of the Japanese Society for Bone and Mineral Research, for the prevention and treatment of glucocorticoid (GC) induced osteoporosis (GIO) and to investigate the risk of fracture and other associated risk factors in bisphosphonate-treated patients. We evaluated 90 female patients with nonrheumatoid arthritis autoimmune diseases who received long-term GC treatment (≥12 months). Clinical characteristics, including age, GC dose, history of fragility fractures, osteoporosis treatments, as well as lumbar (L2–L4) and femoral neck bone mineral density, were collected from the patients’ medical charts. New vertebral fractures during the study period were evaluated using thoracic and lumbar spine radiographs by quantitative measurements. The GIO score was calculated for each patient according to 2014 Japanese guidelines. Of the 90 patients evaluated, 60 were indicated for osteoporosis treatment, based on the 2014 guidelines of Japan. We observed a high compliance rate, with 93% of patients receiving osteoporosis treatment and 50% receiving bisphosphonates. In total, eight patients developed new vertebral fractures during the study, six of whom received bisphosphonates. In bisphosphonate-treated patients, fracture risk was associated with GC treatment and a lack of active vitamin D3 supplementation. The compliance rate with the updated Japanese 2014 guidelines at our institution was very high. Large randomized controlled trials are needed to confirm our findings that suggest that active vitamin D3 should be used in combination with bisphosphonates for the treatment of GIO to reduce fracture risk.
Site-Specific Volumetric Skeletal Changes in Women with a Distal Forearm Fracture
Purpose. To assess site-specific volumetric bone and muscle changes, as well as demographic and biochemical changes, in postmenopausal women with a low-energy distal forearm fracture. Methods. In a cross-sectional case-control study, postmenopausal women with a distal forearm fracture were compared with age- and gender-matched controls. In total, 203 postmenopausal women (104 cases and 99 controls), with a mean age of 65 years, were included. Measurements included peripheral quantitative computed tomography (pQCT) and dual-energy X-ray absorptiometry (DXA) as well as blood sampling and questionnaires. Results. Forearm trabecular volumetric BMD and total BMD assessed with pQCT were significantly lower in fracture cases compared to controls (). Significantly higher cross-sectional area, lower cortical BMD, and lower cortical thickness were seen in women with fracture (, , and , respectively). Postmenopausal women with fracture had significantly lower hip and spine areal BMD assessed with DXA (). Activity level was higher and a history of falling was more frequent in women with fracture ( and , respectively). Vertebral fracture was observed in 24 women (22%) with a distal forearm fracture. Muscle area, muscle density, PTH, and 25OHD did not differ between fracture cases and controls. Conclusion. A distal forearm fracture was associated with site-specific and central bone changes. Postmenopausal women with fracture had a larger bone area in combination with a thinner cortex and lower site-specific total BMD. In addition, women with fracture had a higher activity level, an increased occurrence of previous fall accidents, and a high prevalence of vertebral fractures. Forearm muscle composition, PTH, and 25OHD were not associated with forearm fracture. Fracture preventive measures following a low-energy distal forearm fracture seem beneficial.
Association of Postoperative Neutrophil Lymphocyte Ratio (NLR) and Monocyte Lymphocyte Ratio (MLR) with the Presence of Osteoporosis in Japanese Patients after Hip Fracture Surgery: A Retrospective Cohort Study
Background. The diagnosis of osteoporosis is based on bone mineral density measurements expressed as a percentage of the young adult mean (YAM) in Japan. Osteoporosis is defined as YAM <70%, and intervention is recommended at this cutoff. Because osteoporosis has a strong association with systemic metabolic disorders, we postulated that patients with YAM <70% had higher inflammatory biomarker concentrations owing to the higher systemic stress compared with YAM >70%. Method. We retrospectively reviewed 94 patients with low-trauma hip fractures. Blood examinations were performed on postoperative day (POD) 1 and POD 7. We used neutrophil lymphocyte ratio (NLR) and monocyte lymphocyte ratio (MLR) to evaluate postoperative recovery. After dividing the 94 patients into two groups according to a YAM cutoff of 70%, we compared the differences in NLR and MLR. Results. On POD 1, patients with YAM >70% had a median NLR of 5.7 and a median MLR of 0.66, which were significantly lower than for patients with YAM <70% (8.8 and 0.9, respectively). Similarly, on POD 7, patients with YAM >70% had a median NLR of 2.0 and a median MLR of 0.31, which were significantly lower than for patients with YAM <70% (3.5 and 0.43, respectively). Conclusion. A YAM cutoff of 70% is an appropriate intervention threshold regarding postoperative recovery after hip fracture surgery. Mini-Abstract. Patients with YAM >70% showed lower NLR and MLR on POD 1 and POD 7. A YAM cuffoff of 70% is an appropriate intervention threshold regarding postoperative recovery after hip fracture surgery.
FRAX-Based Intervention Thresholds for Osteoporosis Treatment in Ukraine
Objectives. Osteoporosis, in addition to its consequent fracture burden, is a common and costly condition. FRAX® is a well-established, validated, web-based tool which calculates the 10-year probability of fragility fractures. A FRAX model for Ukraine has been available since 2016 but its output has not yet been translated into intervention thresholds for the treatment of osteoporosis in Ukraine; we aimed to address this unmet need in this analysis. Methods. In a referral population sample of 3790 Ukrainian women, 10-year probabilities of major osteoporotic fracture (MOF) and hip fracture separately were calculated using the Ukrainian FRAX model, with and without femoral neck bone mineral density (BMD). We used a similar approach to that first proposed by the UK National Osteoporosis Guideline Group, whereby treatment is indicated if the probability equals or exceeds that of a woman of the same age with a prior fracture. Results. The MOF intervention threshold in females (the age-specific 10-year fracture probability) increased with age from 5.5% at the age of 40 years to 11% at the age of 75 years where it plateaued and then decreased slightly at age 90 (10%). Lower and upper thresholds were also defined to determine the need for BMD, if not already measured; the approach targets BMD measurements to those at or near the intervention threshold. The proportion of the referral populations eligible for treatment, based on prior fracture or similar or greater probability, ranged from 44% to 69% depending on age. The prevalence of the previous fracture rose with age, as did the proportion eligible for treatment. In contrast, the requirement for BMD testing decreased with age. Conclusions. The present study describes the development and application of FRAX-based assessment guidelines in Ukraine. The thresholds can be used in the presence or absence of access to BMD and optimize the use of BMD where access is restricted.
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 (). 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.