A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures (VERTOS IV)

<p>Abstract</p> <p>Background</p> <p>The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs. The objective of this study is to compare pain relief after PV with a sham intervention in selected patients with an acute osteoporotic VCF using the same strict inclusion criteria as in VERTOS II. Secondary outcome measures are back pain related disability and quality of life.</p> <p>Methods</p> <p>The VERTOS IV study is a prospective, multicenter RCT with pain relief as primary endpoint. Patients with a painful osteoporotic VCF with bone edema on MR imaging, local back pain for 6 weeks or less, osteopenia and aged 50 years or older, after obtaining informed consent, are included and randomized for PV or a sham intervention. In total 180 patients will be enrolled. Follow-up is at regular intervals during a 1-year period with a standard Visual Analogue Scale (VAS) score for pain and pain medication. Necessary additional therapies and complications are recorded.</p> <p>Discussion</p> <p>The VERTOS IV study is a methodologically sound RCT designed to assess pain relief after PV compared to a sham intervention in patients with an acute osteoporotic VCF selected on strict inclusion criteria.</p> <p>Trial registration</p> <p>This study is registered at ClinicalTrials.gov., <a href="http://www.clinicaltrials.gov/ct2/show/NCT01200277">NCT01200277</a>.</p

Bone mineral density in partially recovered early onset anorexic patients - a follow-up investigation

<p>Abstract</p> <p>Background and aims</p> <p>There still is a lack of prospective studies on bone mineral development in patients with a history of early onset Anorexia nervosa (AN). Therefore we assessed associations between bone mass accrual and clinical outcomes in a former clinical sample. In addition to an expected influence of regular physical activity and hormone replacement therapy, we explored correlations with nutritionally dependent hormones.</p> <p>Methods</p> <p>3-9 years (mean 5.2 ± 1.7) after hospital discharge, we re-investigated 52 female subjects with a history of early onset AN. By means of a standardized approach, we evaluated the general outcome of AN. Moreover, bone mineral content (BMC) and bone mineral density (BMD) as well as lean and fat mass were measured by dual-energy x-ray absorptiometry (DXA). In a substudy, we measured the serum concentrations of leptin and insulin-like growth factor-I (IGF-I).</p> <p>Results</p> <p>The general outcome of anorexia nervosa was good in 50% of the subjects (BMI ≥ 17.5 kg/m², resumption of menses). Clinical improvement was correlated with BMC and BMD accrual (χ²= 5.62/χ²= 6.65, p = 0.06 / p = 0.036). The duration of amenorrhea had a negative correlation with BMD (r = -.362; p < 0.01), but not with BMC. Regular physical activity tended to show a positive effect on bone recovery, but the effect of hormone replacement therapy was not significant. Using age-related standards, the post-discharge sample for the substudy presented IGF-I levels below the 5^thpercentile. IGF-I serum concentrations corresponded to the general outcome of AN. By contrast, leptin serum concentrations showed great variability. They correlated with BMC and current body composition parameters.</p> <p>Conclusions</p> <p>Our results from the main study indicate a certain adaptability of bone mineral accrual which is dependent on a speedy and ongoing recovery. While leptin levels in the substudy tended to respond immediately to current nutritional status, IGF-I serum concentrations corresponded to the individual's age and general outcome of AN.</p

The French multicentre elevated bone mass study: prevalence and causes

International audienceThe purpose of this multicentric study was to evaluate the prevalence and causes of Elevated Bone Mass (EBM) in patients who underwent DXA scanning over a 10-year period. The prevalence of EBM was 1 in 100. The main causes of EBM were degenerative spine disorders and renal osteodystrophy. Introduction Reports of elevated bone mass (EBM) on routine dual energy X-Ray absorptiometry (DXA) scanning are not infrequent. However, epidemiological studies of EBM are few and definition thresholds are variable. The purpose of this French multicentric study was to evaluate the prevalence and causes of EBM in adult patients who underwent DXA scanning over a 10-year period. Methods This multicentric, retrospective study was conducted in six French regional bone centres. DXA databases were initially searched for individuals with a bone mineral density (BMD) Z-score &gt;= +4 at any site in the lumbar spine or hip from April 1st, 2008 to April 30st, 2018. Results In all, 72,225 patients with at least one DXA scan were identified. Of these, 909 (322 men and 587 women) had a Z-score &gt;= + 4, i.e. a prevalence of 1.26% [1.18-1.34%]. The DXA scan reports and imagery and medical records of the 909 EBM patients were reviewed and 936 causes were found. In 42 patients (4%), no cause could be determined due to unavailability of data. Artefactual causes of EBM were found in 752 patients (80%), in whom the predominant cause was degenerative disease of the spine (613 patients, 65%). Acquired causes of focal EBM-including Paget's disease (n = 7)-were found in 12 patients (1%), and acquired causes of generalized EBM-including renal osteodystrophy (n = 32), haematological disorders (n = 20) and hypoparathyroidism (n = 15)-in 84 patients (9%). Other causes were rare hereditary diseases and unknown EBM in 19 (2%) and 27 (3%) cases respectively. Conclusions The prevalence of EBM was approximately 1 in 100. These findings suggest that degenerative disease of the spine is the main cause of EBM, but that acquired or hereditary diseases are also causal factors

Cost-effectiveness of percutaneous vertebroplasty in osteoporotic vertebral fractures

A retrospective study was conducted in 179 consecutive patients (48 males, 131 females; mean age: 72.0 ± 8.59 years; range: 51–93) with single symptomatic acute amyelic osteoporotic vertebral fracture presenting between September 2004 and September 2005 to the Santa Lucia Foundation in Rome, Italy. Vertebral fractures usually become manifest due to pain which can be debilitating. Treatment depends on the presence or absence of spinal cord involvement. In the first case, surgical stabilization is mandatory. In the second case, treatment may be performed either by conservative medical therapy (CMT) or percutaneous vertebroplasty (PVT). The aim of this study was to evaluate the effectiveness, costs and cost-effectiveness of percutaneous vertebroplasty. After 2 weeks of analgesic therapy, 153 patients presented refractory pain and were offered treatment by PVT. A total of 58 patients accepted and underwent PVT (PVT group), while 95 refused and underwent conservative medical therapy (CMT group). Follow-up was performed by specialist consults, spine radiography and MRI and a self-assessment questionnaire evaluating pain using a Visual Analogue Scale (VAS) and function using an ambulation and an Activities of Daily Living (ADL) scale. A 12-month follow-up was obtained in 86 of 95 (90.5%) CMT group patients and 54 of 58 (93.1%) PVT group patients. Significant reduction of VAS and improvement of ambulation and ADL was observed in both groups at 1 week and 3 and 12 months (P < 0.05; Wilcoxon signed rank test), however, these results were significantly superior in the PVT group at 1 week and 3 months (P < 0.05; Mann–Whitney U test). Average cost per patient at 1 week and 3 and 12 months were respectively 755.49 ± 661.96, 3791.95 ± 3341.97 and 4299.55 ± 3211.53 € (CMT group) and 3311.35 ± 0.32, 3745.30 ± 3.59 and 4101.05 ± 755.41 € (PVT group). PVT resulted significantly more cost-effective than CMT with regards to the three scales at 1 week (P < 0.05; Mann–Whitney U test). At 3 months PVT was more cost-effective than CMT with regards to the three scales, however, the difference was significant only with regards to ambulation. No significant differences in cost-effectiveness where found between the two groups at 12 months. PVT should be considered the treatment of first choice in symptomatic acute amyelic osteoporotic vertebral fractures with refractory pain after a short period of analgesic therapy