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Health Technology Assessment... Apr 2024Bisphosphonates are a class of medication commonly used to treat osteoporosis. Alendronate is recommended as the first-line treatment; however, long-term adherence (both...
BACKGROUND
Bisphosphonates are a class of medication commonly used to treat osteoporosis. Alendronate is recommended as the first-line treatment; however, long-term adherence (both treatment compliance and persistence) is poor. Alternative bisphosphonates are available, which can be given intravenously and have been shown to improve long-term adherence. However, the most clinically effective and cost-effective alternative bisphosphonate regimen remains unclear. What is the most cost-effective bisphosphonate in clinical trials may not be the most cost-effective or acceptable to patients in everyday clinical practice.
OBJECTIVES
1. Explore patient, clinician and stakeholder views, experiences and preferences of alendronate compared to alternative bisphosphonates. 2. Update and refine the 2016 systematic review and cost-effectiveness analysis of bisphosphonates, and estimate the value of further research into their benefits. 3. Undertake stakeholder/consensus engagement to identify important research questions and further rank research priorities.
METHODS
The study was conducted in two stages, stages 1A and 1B in parallel, followed by stage 2: • Stage 1A - we elicited patient and healthcare experiences to understand their preferences of bisphosphonates for the treatment of osteoporosis. This was undertaken by performing a systematic review and framework synthesis of qualitative studies, followed by semistructured qualitative interviews with participants. • Stage 1B - we updated and expanded the existing Health Technology Assessment systematic review and clinical and cost-effectiveness model, incorporating a more comprehensive review of treatment efficacy, safety, side effects, compliance and long-term persistence. • Stage 2 - we identified and ranked further research questions that need to be answered about the effectiveness and acceptability of bisphosphonates.
RESULTS
Patients and healthcare professionals identified a number of challenges in adhering to bisphosphonate medication, balancing the potential for long-term risk reduction against the work involved in adhering to oral alendronate. Intravenous zoledronate treatment was generally more acceptable, with such regimens perceived to be more straightforward to engage in, although a portion of patients taking alendronate were satisfied with their current treatment. Intravenous zoledronate was found to be the most effective, with higher adherence rates compared to the other bisphosphonates, for reducing the risk of fragility fracture. However, oral bisphosphonates are more cost-effective than intravenous zoledronate due to the high cost of zoledronate administration in hospital. The importance of including patients and healthcare professionals when setting research priorities is recognised. Important areas for research were related to patient factors influencing treatment selection and effectiveness, how to optimise long-term care and the cost-effectiveness of delivering zoledronate in an alternative, non-hospital setting.
CONCLUSIONS
Intravenous zoledronate treatment was generally more acceptable to patients and found to be the most effective bisphosphonate and with greater adherence; however, the cost-effectiveness relative to oral alendronate is limited by its higher zoledronate hospital administration costs.
FUTURE WORK
Further research is needed to support people to make decisions influencing treatment selection, effectiveness and optimal long-term care, together with the clinical and cost-effectiveness of intravenous zoledronate administered in a non-hospital (community) setting.
LIMITATIONS
Lack of clarity and limitations in the many studies included in the systematic review may have under-interpreted some of the findings relating to effects of bisphosphonates.
TRIAL REGISTRATION
This trial is registered as ISRCTN10491361.
FUNDING
This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR127550) and is published in full in ; Vol. 28, No. 21. See the NIHR Funding and Awards website for further award information.
Topics: Humans; Diphosphonates; Alendronate; Zoledronic Acid; Osteoporotic Fractures; Osteoporosis
PubMed: 38634483
DOI: 10.3310/WYPF0472 -
Journal of Endocrinological... Apr 2024Since vertebral fragility fractures (VFFs) might increase the risk of subsequent fractures, we evaluated the incidence rate and the refracture risk of subsequent... (Review)
Review
PURPOSE
Since vertebral fragility fractures (VFFs) might increase the risk of subsequent fractures, we evaluated the incidence rate and the refracture risk of subsequent vertebral and non-vertebral fragility fractures (nVFFs) in untreated patients with a previous VFF.
METHODS
We systematically searched PubMed, Embase, and Cochrane Library up to February 2022 for randomized clinical trials (RCTs) that analyzed the occurrence of subsequent fractures in untreated patients with prior VFFs. Two authors independently extracted data and appraised the risk of bias in the selected studies. Primary outcomes were subsequent VFFs, while secondary outcomes were further nVFFs. The outcome of refracture within ≥ 2 years after the index fracture was measured as (i) rate, expressed per 100 person-years (PYs), and (ii) risk, expressed in percentage.
RESULTS
Forty RCTs met our inclusion criteria, ranging from medium to high quality. Among untreated patients with prior VFFs, the rate of subsequent VFFs and nVFFs was 12 [95% confidence interval (CI) 9-16] and 6 (95% CI 5-8%) per 100 PYs, respectively. The higher the number of previous VFFs, the higher the incidence. Moreover, the risk of VFFs and nVFFs increased within 2 (16.6% and 8%) and 4 years (35.1% and 17.4%) based on the index VFF.
CONCLUSION
The highest risk of subsequent VFFs or nVFFs was already detected within 2 years following the initial VFF. Thus, prompt interventions should be designed to improve the detection and treatment of VFFs, aiming to reduce the risk of future FFs and properly implement secondary preventive measures.
Topics: Humans; Randomized Controlled Trials as Topic; Spinal Fractures; Fractures, Bone; Spine; Osteoporotic Fractures
PubMed: 37921990
DOI: 10.1007/s40618-023-02222-0 -
Medicine Nov 2023To investigate the effect of Vertebral augmentation (VA) in the treatment of single-level osteoporotic vertebral compression fractures (OVCFs) on new vertebral fractures. (Meta-Analysis)
Meta-Analysis
The risk of new vertebral fracture after percutaneous vertebral augmentation in patients suffering from single-level osteoporotic vertebral compression fractures: A meta-analysis and systematic review.
BACKGROUND
To investigate the effect of Vertebral augmentation (VA) in the treatment of single-level osteoporotic vertebral compression fractures (OVCFs) on new vertebral fractures.
METHODS
Electronic databases Pubmed, Embase, and the Cochrane Central Register of Controlled Trials were searched from database creation to 5 September 2022. Eligible studies had to use VA as an intervention and conservative treatment as a control group. Studies had to explicitly report whether new vertebral fractures occurred during follow-up. Data were extracted by multiple investigators. Data were pooled using random or fixed effects models depending on the degree of heterogeneity.
RESULTS
Of the 682 articles screened, 7 met the inclusion criteria and were included in the analysis, giving a total of 1240 patients. Meta-analysis showed that VA (OR = 2.10, 95% CI: 1.35-3.28, P = .001) increased the risk of new postoperative vertebral fractures compared with conservative treatment. Subgroup analyses showed that the risk was greater in the group with a follow-up time greater than 1 year (OR = 2.57, 95% CI: 1.06-6.26, P = .001). Compared with conservative treatment, VA (OR = 2.17, 95% CI: 1.23-3.82, P = .007) increased the risk of postoperative adjacent vertebral fracture.
CONCLUSION SUBSECTIONS
VA is associated with an increased risk of new vertebral fractures and adjacent vertebral fractures following single-level OVCFs. With longer follow-ups, new vertebral fractures may be more significant. Clinical surgeons should pay attention to long-term postoperative complications and choose treatment carefully.
Topics: Humans; Spinal Fractures; Fractures, Compression; Kyphoplasty; Vertebroplasty; Osteoporotic Fractures; Treatment Outcome
PubMed: 37986316
DOI: 10.1097/MD.0000000000035749 -
Osteoporosis guidelines on TCM drug therapies: a systematic quality evaluation and content analysis.Frontiers in Endocrinology 2023The aims of this study were to evaluate the quality of osteoporosis guidelines on traditional Chinese medicine (TCM) drug therapies and to analyze the specific...
OBJECTIVE
The aims of this study were to evaluate the quality of osteoporosis guidelines on traditional Chinese medicine (TCM) drug therapies and to analyze the specific recommendations of these guidelines.
METHODS
We systematically collected guidelines, evaluated the quality of the guidelines using the (AGREE) II tool, and summarized the recommendations of TCM drug therapies using the Patient-Intervention-Comparator-Outcome (PICO) model as the analysis framework.
RESULTS AND CONCLUSIONS
A total of 20 guidelines were included. Overall quality evaluation results revealed that four guidelines were at level A, four at level B, and 12 at level C, whose quality needed to be improved in the domains of "stakeholder involvement", "rigor of development", "applicability" and "editorial independence". Stratified analysis suggested that the post-2020 guidelines were significantly better than those published before 2020 in the domains of "scope and purpose", "stakeholder involvement" and "editorial independence". Guidelines with evidence systems were significantly better than those without evidence systems in terms of "stakeholder involvement", "rigor of development", "clarity of presentation" and "applicability". The guidelines recommended TCM drug therapies for patients with osteopenia, osteoporosis and osteoporotic fracture. Recommended TCM drugs were mainly Chinese patent medicine alone or combined with Western medicine, with the outcome mainly focused on improving bone mineral density (BMD).
Topics: Humans; Medicine, Chinese Traditional; Osteoporosis; Osteoporotic Fractures; Research Design
PubMed: 38317713
DOI: 10.3389/fendo.2023.1276631 -
Annals of Internal Medicine Jun 2024
Meta-Analysis
Update Alert: Effectiveness and Safety of Treatments to Prevent Fractures in People With Low Bone Mass or Primary Osteoporosis: A Living Systematic Review and Network Meta-analysis for the American College of Physicians.
Topics: Humans; Osteoporosis; Osteoporotic Fractures; Bone Density Conservation Agents; Bone Density; Network Meta-Analysis
PubMed: 38710084
DOI: 10.7326/L24-0118