Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial.

BACKGROUND: Percutaneous vertebroplasty is increasingly used for treatment of pain in patients with osteoporotic vertebral compression fractures, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. We aimed to clarify whether vertebroplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures. METHODS: Patients were recruited to this open-label prospective randomised trial from the radiology departments of six hospitals in the Netherlands and Belgium. Patients were aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated randomisation codes with a block size of six. Masking was not possible for participants, physicians, and outcome assessors. The primary outcome was pain relief at 1 month and 1 year as measured by VAS score. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT00232466. FINDINGS: Between Oct 1, 2005, and June 30, 2008, we identified 431 patients who were eligible for randomisation. 229 (53%) patients had spontaneous pain relief during assessment, and 202 patients with persistent pain were randomly allocated to treatment (101 vertebroplasty, 101 conservative treatment). Vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was -5·2 (95% CI -5·88 to -4·72) after vertebroplasty and -2·7 (-3·22 to -1·98) after conservative treatment, and between baseline and 1 year was -5·7 (-6·22 to -4·98) after vertebroplasty and -3·7 (-4·35 to -3·05) after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2·6 (95% CI 1·74-3·37, p<0·0001) at 1 month and 2·0 (1·13-2·80, p<0·0001) at 1 year. No serious complications or adverse events were reported. INTERPRETATION: In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost. FUNDING: ZonMw; COOK Medical.

Percutaneous Vertebroplasty is no Risk Factor for New Vertebral Fractures and Protects Against Further Height Loss (VERTOS IV).

BACKGROUND: Percutaneous vertebroplasty (PV) is an alternative option to treat pain after an osteoporotic vertebral compression fracture (OVCF). Controversy exists as to whether PV increases the risk of new OVCFs or prevents further vertebral height loss in treated levels. We assessed both during 1-year follow-up in patients with acute OVCF randomised to PV or a sham procedure. METHODS: VERTOS IV is a prospective, multicentre, randomised controlled trial comparing PV with sham therapy in 180 patients. New OVCFs and further vertebral height loss were assessed at 3, 6, and 12 months. RESULTS: After a median follow-up of 12 months (interquartile range (IQR) = 12-12) 31 new fractures were reported in 15 patients from the PV group and 28 new fractures in 19 patients from the sham group. The occurrence of new vertebral fractures did not significantly differ between the groups (χ2(1) = 0.83, p = 0.36, OR = .71, 95%CI = 0.33-1.50). There was no higher fracture risk of adjacent versus distant vertebrae. After sham procedure, further height loss of treated vertebrae occurred more frequently (7 patients (8%) in the PV group and 39 (45%) in the sham group (χ2(1) = 28.85, p < 0.001, OR = 9.84, 95%CI = 4.08-23.73)) and was more severe (p < .001) than after PV. CONCLUSIONS: The risk of further vertebral height loss is significantly lower after PV compared to a sham intervention, i.e. PV protects against progressive vertebral height loss. In addition, PV does not increase the risk of new adjacent and distant OVCFs. LEVEL OF EVIDENCE: Level 1a, therapeutic study. ClinicalTrials.gov number, NCT01200277.

The fracture and osteoporosis clinic: 1-year results and 3-month compliance.

INTRODUCTION: A Fracture and Osteoporosis (F&O) clinic started in two major general hospitals in the South of the Netherlands on April 1st 2004. Its objectives were to perform easy and complete assessment of female and male patients aged 50 years and over, initially treated for a low-energy trauma fracture, and to evaluate its effectiveness for early diagnosis and treatment of osteoporosis. METHODS: All eligible patients were selected from the digital X-ray system of the Emergency Department. DXA-scans and, if indicated, spinal radiographs were made. If osteoporosis was diagnosed, the F&O nurse explained the treatment strategy. Treatment advice was sent to the general practitioner (GP), who prescribed medication and provided further support. After 3 months, all osteoporosis patients received a compliance and side effects follow-up questionnaire. RESULTS: Up to June 1st 2005, 1058 patients followed the diagnostic procedure; 584 patients did not. Three times more women (804) than men (254) suffered a fracture. Osteoporosis occurred 10% more often in women. Overall, 37.1% had osteoporosis, based on DXA-scan only, and 39.6% when spinal radiographs were added. Spinal radiographs of the thoracic and or lumbar spine were made in 166 patients, radiographs of the thorax in 114 patients. Overall, fractures of the wrist were most common, with fractures of the hand occurring most frequently in men (20.0%). All fracture sites, except foot and clavicula, were associated with a higher frequency of osteoporosis than in the Dutch population. The response rate to the 3-month compliance questionnaire was 73% increasing to 96% after telephone contact. 86% visited their GP; 11% did not because they already received anti-osteoporotic medication prior to the fracture. Bisphosphonates were prescribed to 84% and discontinued by 7%. 13% reported side effects of bisphosphonates. Only half of the patients received the recommended calcium supplementation. CONCLUSIONS: The F&O clinic with its digital X-ray system facilitated easy, complete identification of fracture patients and early treatment of osteoporosis, which was frequently diagnosed. Self-reported compliance was high.

Mindfulness-based cognitive therapy for people with diabetes and emotional problems: long-term follow-up findings from the DiaMind randomized controlled trial.

OBJECTIVE: The DiaMind trial showed beneficial immediate effects of mindfulness-based cognitive therapy (MBCT) on emotional distress, but not on diabetes distress and HbA1c. The aim of the present report was to examine if the effects would be sustained after six month follow-up. METHODS: In the DiaMind trial, 139 outpatients with diabetes (type-I or type-II) and a lowered level of emotional well-being were randomized into MBCT (n=70) or a waiting list with treatment as usual (TAU: n=69). Primary outcomes were perceived stress, anxiety and depressive symptoms, and diabetes distress. Secondary outcomes were, among others, health status, and glycemic control (HbA1c). RESULTS: Compared to TAU, MBCT showed sustained reductions at follow-up in perceived stress (p<.001, d=.76), anxiety (p<.001, assessed by HADS d=.83; assessed by POMS d=.92), and HADS depressive symptoms (p=.004, d=.51), but not POMS depressive symptoms when using Bonferroni correction for multiple testing (p=.016, d=.48). No significant between-group effect was found on diabetes distress and HbA1c. CONCLUSION: This study showed sustained benefits of MBCT six months after the intervention on emotional distress in people with diabetes and a lowered level of emotional well-being. TRIAL REGISTRATION: Dutch Trial Register NTR2145, http://www.trialregister.nl.

The effects of a mindfulness-based intervention on emotional distress, quality of life, and HbA(1c) in outpatients with diabetes (DiaMind): a randomized controlled trial.

OBJECTIVE: Emotional distress is common in outpatients with diabetes, affecting ∼20-40% of the patients. The aim of this study was to determine the effectiveness of group therapy with Mindfulness-Based Cognitive Therapy (MBCT), relative to usual care, for patients with diabetes with regard to reducing emotional distress and improving health-related quality of life and glycemic control. RESEARCH DESIGN AND METHODS: In the present randomized controlled trial, 139 outpatients with diabetes (type 1 or type 2) and low levels of emotional well-being were randomized to MBCT (n = 70) or a waiting list group (n = 69). Primary outcomes were perceived stress (Perceived Stress Scale), anxiety and depressive symptoms (Hospital Anxiety and Depression Scale), mood (Profiles of Mood States), and diabetes-specific distress (Problem Areas In Diabetes). Secondary outcomes were health-related quality of life (12-Item Short-Form Health Survey), and glycemic control (HbA(1c)). Assessments were conducted at baseline and at 4 and 8 weeks of follow-up. RESULTS: Compared with control, MBCT was more effective in reducing stress (P < 0.001, Cohen d = 0.70), depressive symptoms (P = 0.006, d = 0.59), and anxiety (P = 0.019, d = 0.44). In addition, MBCT was more effective in improving quality of life (mental: P = 0.003, d = 0.55; physical: P = 0.032, d = 0.40). We found no significant effect on HbA(1c) or diabetes-specific distress, although patients with elevated diabetes distress in the MBCT group tended to show a decrease in diabetes distress (P = 0.07, d = 0.70) compared with the control group. CONCLUSIONS: Compared with usual care, MBCT resulted in a reduction of emotional distress and an increase in health-related quality of life in diabetic patients who had lower levels of emotional well-being.