Bisphosphonate alternative regimens for the prevention of osteoporotic fragility fractures: BLAST-OFF, a mixed-methods study.

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 Health Technology Assessment; Vol. 28, No. 21. See the NIHR Funding and Awards website for further award information.

Bisphosphonates are drug treatments commonly used to treat osteoporosis. Alendronate is the most used and is taken by mouth, weekly at a specific time of the week, which can be challenging. Less than one in four people continue this treatment beyond 2 years. Alternative bisphosphonates are available, which vary in frequency and how they are administered. The most acceptable and best value-for-money regimen is unclear. Our aim was to determine how effective alternative bisphosphonates are compared to alendronate at preventing fractures and whether reduction in fracture risk was achieved at a reasonable financial cost, but acceptable to patients. The study was conducted in two stages, stages 1A and 1B in parallel, followed by stage 2: Stage 1A: a review of the published evidence on patients' and doctors' views, experiences and preferences regarding different bisphosphonate treatment regimens, followed by interviews with patients and healthcare professionals. Stage 1B: an update of an existing study on how effective bisphosphonates are in preventing fragility fractures caused by osteoporosis and whether they are good value for money. Stage 2: identification of questions that need to be answered about the effectiveness and acceptability of bisphosphonate treatments. Taking bisphosphonate medication often involves quite a lot of effort by patients, particularly when taking alendronate tablets. A yearly infusion of zoledronate treatment was more acceptable, easier to engage with and the most effective treatment compared to alendronate. However, the cost of administering zoledronate in hospital made alendronate better value for money. Bisphosphonates are effective in reducing the risk of fracture, but 'continuing with treatment', particularly alendronate tablets, remains a challenge. A yearly infusion of zoledronate offers an acceptable and effective treatment, but further research is needed to support patients and healthcare professionals in making decisions about the various treatments, benefits and cost savings of administering zoledronate outside of hospital and in the community.

Vision Screening in Older Adults Admitted with a Fragility Hip Fracture: A Healthcare Quality Improvement Report.

Background: This healthcare quality improvement report focussed on the effectiveness of an orthoptic-led inpatient vision screening service at Nottingham University Hospitals for older adults admitted with a fragility hip fracture. The service was developed in response to national guidance, which recommended a multifactorial assessment, including a vision assessment for older adults presenting following a fall. Method: Vision screening was carried out by orthoptists on eligible patients ≥65 years of age admitted to the trauma and orthopaedic wards with a hip fracture. Retrospective data for patients screened between 2015-2019 were analysed, including: patient demographics; screening eligibility and outcome; ophthalmology referrals made; ophthalmology appointment attendance; and outcome. Results: Of the 3321 patients admitted with a hip fracture between 2015-2019, 2033 (61%) were eligible for vision screening and 1532 (75%) of these were screened. Furthermore, 784 (51%) of the patients screened had an ocular abnormality requiring an ophthalmology referral, or a sight test at an optician. Only 144 of the 383 (38%) who required an ophthalmology referral via the GP were successfully referred, and only 107 of the 186 (58%) patients who were given appointments attended them. Additionally, 98 of 107 had pathology, with cataracts the most common finding (51%), and 61 of 98 (62%) patients had treatable vision impairment. Conclusions: We found a large proportion of fragility hip fracture patients with impaired vision, much of which was treatable and could be detected effectively with orthoptic-led bedside screening. The most common eye problem in those referred to ophthalmology was cataracts. An internal referral pathway to ophthalmology is proposed. There is a need to investigate reasons for disengagement with eye care services in this population.

Comparison of the taste and acceptability of a new high protein ice cream (Nottingham-Ice cream) with standard hospital milkshake oral nutritional supplement in older people with fragility fractures: a short report.

INTRODUCTION: Oral nutritional supplement (ONS) prescription iscommonly recommended for older patients with hip fractures. However, ONS compliance is often low. Ice cream may be a promising nutritional intervention. Using a Plan-Do-Study Act methodology we describe the second cycle of a project using an ice cream based nutritional supplement called Nottingham-Ice cream (N-ICE CREAM) to address malnutrition in older adults. The project aimed to identify whether N-ICE CREAM is a suitable option/alternative to standard ONS. METHODS: Fifty older (≥ 65 years) inpatients with hip or spine fractures were recruited. Both groups received two days each of N-ICE CREAMand milkshake ONS. We measured compliance, acceptability (rating 0"dislike a lot" to 7 "like a lot"), attitudes towards prescription length (rating 0 "very unconfident" to 4 "very confident") and preference. RESULTS: Mean (standard deviation, SD) patient age was 80.6 (7.7) years. The majority (n = 21, 67.7%) preferred N-ICE CREAM. Mean compliance to N-ICE CREAM was greater in both groups (group A (n = 22) 69.9 (30.0)% and group B (n = 26) 56.3 (39.3)%) compared to milkshake ONS (group A (n = 22) 43.4 (4.7)% and group B (n = 26) 53.6 ± (40.2)%). Mean acceptability ratings were higher for N-ICE CREAM, thus the overall impression score was greater. Confidence score for both products decreased with increasing time. CONCLUSIONS: N-ICE CREAM is more accepted by older patients with hip or spine fractures compared to milkshake ONS. Further research should explore long-term compliance and clinical outcomes.

Are we achieving the standards of good nutritional care for older people in hospital with fragility fractures?

Malnutrition is common in older people with fragility fractures and is associated with poor clinical outcomes and increased risk of complications. The UK National Health Service has published national standards for food and drink for patients, staff and visitors, in hospitals. These standards describe the methods to ensure quality and sustainability.We assessed these standards and report the nutritional status of older (70 years of age) patients admitted to hospital with fragility fracture, and weighed food trolley and plate waste after lunch and supper for five days.There were 19 older patients with fragility fractures on the trauma and orthopaedic ward. The mean intake for 'nutritionally well' was 1592 kcal/day and 65.7 g/day protein; the mean intake for 'nutritionally vulnerable' was 643 kcal/day and 24.8 g/day protein.Although all key characteristics of good nutrition and hydration care for patients in hospital were achieved, energy and protein intake was poor in the nutritionally vulnerable group. Further interventions are necessary to improve dietary intake in hospital, particularly in those who are nutritionally vulnerable.

Spinal medial branch nerve root block (MBNB) intervention compared to standard care-vertebroplasty (VP) for the treatment of painful osteoporotic vertebral fractures in frail, older hospitalised patients: a feasibility study.

Our study aimed to assess the feasibility outcomes comparing spinal medial branch nerve root block intervention to standard care vertebroplasty for the treatment of painful osteoporotic vertebral fractures in frail, hospitalised older patients. We found the study to be feasible and now propose a clinical effectiveness, cost effectiveness and safety evaluation. INTRODUCTION: Vertebroplasty (VP) is a key-hole procedure involving injection of bone cement into a fractured vertebral body, to reduce pain and increase vertebral body stability, although it is associated with a small risk of complications, particularly in frail, older hospitalised patients. Medial branch spinal nerve block (MBNB) may be an alternative treatment to alleviate pain symptoms, with less complications; however, no study has prospectively compared the clinical effectiveness, cost-effectiveness and safety of MBNB to VP, in frail, older hospitalised patients. The aim of our study was to conduct a 1st stage feasibility study, exploring recruitment, retention and several outcomes measures (means and SDs), together with qualitative interviews to assess participant and clinician views, to inform a definitive larger study. METHODS: We conducted a two-arm feasibility randomised controlled trial with participants allocated to continue with routine surgical care-VP or MBNB treatment, with an embedded qualitative study. Data was collected at baseline, week 1, 4, and week 8. RESULTS: Out of 40 eligible patients, 30 (75%) consented to take part in the study. The overall median time from randomisation to intervention was 3 days, IQR 1-7 days, 5 (1-7) days for VP and 2 (1-3) days for MBNB. Median (IQR) length of hospital stay for the VP group was 20 (8) days and for the MBNB 15(22) days. The proportion of completeness of outcome data collection at weeks 1, 4 and 8 was at least 77%: 14 (100%), 12 (85.7%) and 11(78.9%) for VP and 13 (100%), 12 (92.3%) and 10 (76.8%) for MBNB, respectively. There were no significant difference in the clinical outcomes or adverse events between the two groups. DISCUSSION: Our study was feasible in achieving is target recruitment, participants adhered to the randomisation and at least 77% completeness of data at the 8 week end-point (target 75%). We now plan to conduct a definitive clinical effectiveness, cost effectiveness and safety outcome study, comparing VP to MBNB in frail, older patients hospitalised with an acute vertebral osteoporotic fracture.

Clinicians' views of prescribing oral and intravenous bisphosphonates for osteoporosis: a qualitative study.

BACKGROUND: Bisphosphonate medications, including alendronate, ibandronate and risedronate administered orally and zoledronate, administered intravenously, are commonly prescribed for the treatment of osteoporosis based on evidence that, correctly taken, bisphosphonates can improve bone strength and lead to a reduction in the risk of fragility fractures. However, it is currently unclear how decisions to select between bisphosphonate regimens, including intravenous regimen, are made in practice and how clinicians support patients with different treatments. METHODS: This was an interpretivist qualitative study. 23 semi-structured telephone interviews were conducted with a sample of general practitioners (GPs), secondary care clinicians, specialist experts as well as those providing and leading novel treatments including participants from a community intravenous (IV) zoledronate service. Data analysis was undertaken through a process of iterative categorisation. RESULTS: The results report clinicians varying experiences of making treatment choices, as well as wider aspects of osteoporosis care. Secondary care and specialist clinicians conveyed some confidence in making treatment choices including on selecting IV treatment. This was aided by access to diagnostic testing and medication expertise. In contrast GPs reported a number of challenges in prescribing bisphosphonate medications for osteoporosis and uncertainty about treatment choice. Results also highlight how administering IV zoledronate was seen as an opportunity to engage in broader care practices. CONCLUSION: Approaches to making treatment decisions and supporting patients when prescribing bisphosphonates for osteoporosis vary in practice. This study points to the need to co-ordinate osteoporosis treatment and care across different care providers.

Call to action: a five nations consensus on the use of intravenous zoledronate after hip fracture.

Currently in the UK and Ireland, after a hip fracture most patients do not receive bone protection medication to reduce the risk of refracture. Yet randomised controlled trial data specifically examining patients with hip fracture have shown that intravenous zoledronate reduces refracture risk by a third. Despite this evidence, use of intravenous zoledronate is highly variable following a hip fracture; many hospitals are providing this treatment, whilst most are currently not. A range of clinical uncertainties, doubts over the evidence base and practical concerns are cited as reasons. This paper discusses these concerns and provides guidance from expert consensus, aiming to assist orthogeriatricians, pharmacists and health services managers establish local protocols to deliver this highly clinically and cost-effective treatment to patients before they leave hospital, in order to reduce costly re-fractures in this frail population.

Research priorities regarding the use of bisphosphonates for osteoporosis: a UK priority setting exercise.

PURPOSE: Worldwide, many people who would benefit from osteoporosis drugs are not offered or receiving them, resulting in an osteoporosis care gap. Adherence with bisphosphonates is particularly low. This study aimed to identify stakeholder research priorities relating to bisphosphonate treatment regimens for prevention of osteoporotic fractures. METHODS: A three-step approach based on the James Lind Alliance methodology for identification and prioritisation of research questions was used. Research uncertainties were gathered from a large programme of related research studies about bisphosphonate regimens and from recent published international clinical guidelines. Clinical and public stakeholders refined the list of uncertainties into research questions. The third step prioritised the questions using a modified nominal group technique. RESULTS: In total, 34 draft uncertainties were finalised into 33 research questions by stakeholders. The top 10 includes questions relating to which people should be offered intravenous bisphosphonates first line (1); optimal duration of treatment (2); the role of bone turnover markers in treatment breaks (3); support patient need for medicine optimisation (4); support primary care practitioner need regarding bisphosphonates (5); comparing zoledronate given in community vs hospital settings (6); ensuring quality standards are met (7); the long-term model of care (8); best bisphosphonate for people aged under 50 (9); and supporting patient decision-making about bisphosphonates (10). CONCLUSION: This study reports, for the first time, topics of importance to stakeholders in the research of bisphosphonate osteoporosis treatment regimens. These findings have implications for research into implementation to address the care gap and education of healthcare professionals. Using James Lind Alliance methodology, this study reports prioritised topics of importance to stakeholders in the research of bisphosphonate treatment in osteoporosis. The priorities address how to better implement guidelines to address the care gap, understanding patient factors influencing treatment selection and effectiveness, and how to optimise long-term care.

A 3-year retrospective analysis of patients admitted with clinical vertebral fragility fractures across hospitals in England, UK.

Our database aimed to assess the impact of vertebral fragility fractures (VFFs) on hospitalisation in England. The results showed that admissions secondary to VFF are increasing annually, more significantly in patients aged 75 years and over. Vertebral augmentation has been showed to reduce length of stay in hospital. INTRODUCTION: Vertebral fragility fractures (VFFs) are the most common osteoporotic fracture. VFF can result in significant pain requiring hospitalisation. However, there are little data on patient numbers, hospital bed days, and costs, contributed to by these patients. METHODOLOGY: We report a retrospective analysis of patients aged 55 years and over admitted to hospitals across England from 2017 to 2019. ICD-10 classifications for VFF and OPCS codes were used to identify admissions and patients who had undergone vertebral augmentation (VA). RESULTS: There were 99,370 patients (61% female) admitted during this period, with 64,370 (65%) patients aged over 75 years. There was a 14.3% average increase in admissions annually. Patients aged over 75 years accounted for 1.5 million bed days, costing £465 million (median length of stay (MLOS) 14.4 days). In comparison, those aged 55-74 years, accounted for 659,000 bed days, costing £239 million (MLOS 10.7 days). The majority of patients (84%) were admitted under a non-surgical speciality and were primarily older (median age 76.8 vs 67.6 years, MLOS 8.2 vs 6.0 days), compared to those admitted to surgical wards 1755 patients underwent vertebral augmentation (VA) (1.8% of the total cohort). The median age of patients undergoing VA was 73.3 years, with 775 (44.2%) of these were aged 75 years and over. In comparison, the median age of patients managed conservatively (non-surgically) was 75.7 years, with 63,595 patients (65.1%) aged 75 years and over. The MLOS and cost per patient admission were lower in the VA group compared to those managed non-surgically. CONCLUSION: Hospitalised VFF patients represented a significant number, cost, and use of bed days. Those undergoing VA had a significantly shorter length of stay. Further studies are necessary to define those who may benefit from early VA.

Acceptability and engagement amongst patients on oral and intravenous bisphosphonates for the treatment of osteoporosis in older adults.

BACKGROUND: Osteoporosis is common in older adults leading to fragility fractures at enormous individual and economic cost. Improving long-term adherence with bisphosphonate treatments reduces fracture risk, but adherence rates for first-line oral bisphosphonate alendronate remains low. Although alternative treatment regimens, including annual intravenous infusions are available, patient acceptability remains unclear. Therefore, understanding patients' acceptability and engagement in different bisphosphonate regimens is important to ensure optimal treatment benefits. METHODS: Semi-structured interviews were conducted with 78 patients with a mean age of 69.9 years, who had taken or received bisphosphonates for osteoporosis within the last 24 months. Data analysis included iterative categorisation and used the theoretical framework of acceptability (TFA) to compare the acceptability of treatments regimens. RESULTS: Treatment acceptability and engagement were influenced by the extent to which patients understood the prescribed treatment, and evidence of the treatment working. Acceptability and engagement were compromised when treatment was perceived as burdensome, personal costs were incurred, and patients' values were incompatible with the regimen. The balancing of these factors contributed to patients' ability to cope with the treatment and their emotional responses. Intravenous treatment was generally perceived as easier to understand, more effective, less burdensome with fewer opportunity costs, and a preferable regimen compared with oral bisphosphonates. CONCLUSIONS: Annual intravenous zoledronate bisphosphonate treatment was generally more acceptable to patients, perceived as more straightforward to engage in, although a small portion of patients on oral bisphosphonates were satisfied with treatment. Further research is needed to identify how acceptability and engagement can be optimised.

The Acute VertEbRal AugmentaTion (AVERT) study: protocol for a randomised controlled, feasibility trial of spinal medial branch nerve block in hospitalised older patients with vertebral fragility fractures.

INTRODUCTION: Vertebral fragility fractures (VFFs) are the most common type of osteoporotic fracture found in older people, resulting in increasing morbidity and excess mortality. These fractures can cause significant pain, requiring admission to hospital. Vertebroplasty (VP) is effective in reducing pain and allowing early mobilisation in hospitalised patients. However, it may be associated with complications such as cement leakage, infection, bleeding at the injection site and fracture of adjacent vertebrae. It is also costly and not readily accessible in many UK hospitals.A recent retrospective study reported that spinal medial branch nerve block (MBNB), typically used to treat facet arthropathy, had similar efficacy in terms of pain relief compared with VP for the treatment of painful VFF. However, to date, no study has prospectively compared MBNB to VP. We therefore propose a prospective feasibility randomised controlled trial (RCT) to compare the role of MBNB to VP, in hospitalised older patients. METHOD: A parallel, two-arm RCT with participants allocated on a 1:1 ratio to either standard care-VP or MBNB in hospitalised patients aged over 70 with acute osteoporotic vertebral fractures. Follow-up will be at weeks 1, 4 and 8 post intervention. The primary objective is to determine the feasibility and design of a future trial, including specific outcomes of recruitment, adherence to randomisation and safety. Embedded within the trial will be a health economic evaluation to understand resource utilisation and implications of the intervention and a qualitative study of the experiences and insights of trial participants and clinicians. Secondary outcomes will include pain scores, analgesia requirements, resource use and quality of life data. ETHICS AND DISSEMINATION: Ethical approval was granted by the Yorkshire & the Humber Research Ethics Committee (reference 21/YH/0065). AVERT (Acute VertEbRal AugmentaTion) has received approval by the Health Research Authority (reference IRAS 293210) and is sponsored by Nottingham University Hospitals NHS Trust (reference 21HC001). Recruitment is ongoing. Results will be presented at relevant conferences and submitted to appropriate journals for publication on completion. TRIAL REGISTRATION NUMBER: ISRCTN18334053.

ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation): randomised controlled, feasibility trial in older people.

OBJECTIVE: To determine the feasibility of designing and conducting a definitive trial to evaluate the effectiveness of sacral fracture fixation compared with non-surgical management among older people admitted with a lateral compression pelvic fragility fracture (PFF). DESIGN: Single-site, parallel, two-arm randomised controlled feasibility trial. SETTING: A UK tertiary centre hospital. PARTICIPANTS: Patients aged ≥70 years who were ambulating pre-injury requiring hospital admission (within 28 days of injury) with a type 1 lateral compression PFF. INTERVENTIONS: The intervention group received sacral fracture fixation (cement augmentation±screw fixation) within 7 days of randomisation. Routine preoperative and postoperative care followed each surgical intervention. The control group received usual care consisting of analgesia, and regular input from the medical and therapy team. PRIMARY AND SECONDARY OUTCOME MEASURES: The feasibility outcomes were the number of eligible patients, willingness to be randomised, adherence to allocated treatment, retention, data on the completeness and variability of the proposed definitive trial outcome measures, and reported adverse events. RESULTS: 241 patients were screened. 13 (5.4%) were deemed eligible to participate. Among the eligible participants, nine (69.2%) were willing to participate. Five participants were randomised to the intervention group and four to the control group. The clinicians involved were willing to allow their patients to be randomised and adhere to the allocated treatment. One participant in the intervention group and two participants in the control group received their allocated treatment. All participants were followed up until 12 weeks post-randomisation, and had an additional safety follow-up assessment at 12 months. Overall, the proportion of completeness of outcome measures was at least 75%. No adverse events were directly related to the trial. CONCLUSIONS: There were significant challenges in recruiting sufficient participants which will need to be addressed prior to a definitive trial. TRIAL REGISTRATION NUMBER: ISRCTN16719542.

Association between pre-operative complications, comorbidities, and in-hospital mortality in a hip fracture cohort: a register study in a tertiary hospital in Brazil.

PURPOSE: The incidence of hip fractures is increasing exponentially due to an aging Brazilian population. Older people had significant comorbidities which increases the risk of post-operative mortality. Our purpose was to examine the association between pre-operative infections and comorbidities on the risk of post-operative in-hospital mortality after proximal femur fracture surgery's, beyond that, to evaluate the association between comorbidities and time to surgery. METHODS: This is a population-based cohort retrospective study, using medical records of all six year consecutive surgical procedures for correction of hip fracture in a tertiary teaching Hospital in Brazil. The exclusion criteria aimed to exclusively allocate patients who had their first hip fracture secondary to low-energy trauma. Multivariate logistical regression was performed and receiver operating characteristic (ROC) curve with area under curve (AUC) to evaluate the sensitivity and specificity of the model. p-value < 0.05 was considered significant. RESULTS: Final sample was composed by 856 consecutive patients with 81 years of median and 164 patients were excluded. The median length of hospital say was five days with - l mortality at 3.6%. Significant variables for increased mortality included the presence of pre-operative infection (odds ratio (OR): 3.9(1.12-8.54), chronic obstructive pulmonary disease (COPD) (OR: 3.83(1.36-10.82)), and systemic arterial hypertension (SAH) (OR: 4.1(1.18-14.25)). Development of pre-operative infection was associated with a delay to surgery (OR: 1.1 (1.08-1.13)). CONCLUSIONS: In older people with proximal femur fracture, the presence of pre-operative infection, COPD and SAH were the strongest risk factor for post-operative in-hospital mortality. Pre-operative infection was associated with statistically significant delay to surgery.

Assessing the Effectiveness of Bisphosphonates for the Prevention of Fragility Fractures: An Updated Systematic Review and Network Meta-Analyses.

Bisphosphonates have been found to be effective in preventing fragility fractures. However, their comparative effectiveness in populations at risk has yet to be defined. In light of recent clinical trials, we aimed to compare four bisphosphonates (alendronate, ibandronate, risedronate, and zoledronate) and to identify which are the most effective for the prevention of fragility fractures. This is an update of a systematic review previously published as part of a NICE HTA report. We conducted a systematic review and network meta-analysis, updating the estimates regarding the comparative effectiveness of the aforementioned bisphosphonates. Studies identified from published and unpublished sources between 2014 and 2021 were added to the studies identified in the previous review. Screening, data extraction and risk of bias assessment were independently undertaken by two reviewers. Outcomes were fractures, femoral neck bone mineral density (BMD), mortality, and adverse events. We identified 25 additional trials, resulting in a total population of 47,007 participants. All treatments had beneficial effects on fractures versus placebo with zoledronate being the most effective treatment in preventing vertebral fractures (hazard ratio [HR] 0.38; 95% credibility interval [CrI], 0.28-0.49). Zoledronate (HR 0.71; 95% CrI, 0.61-0.81) and risedronate (HR 0.70; 95% CrI, 0.53-0.84) were found to be the most effective treatments in preventing nonvertebral fractures. All treatments were associated with increases in femoral neck BMD versus placebo with zoledronate being the most effective treatment mean difference (MD 4.02; 95% CrI, 3.2-4.84). There was a paucity of data regarding hip and wrist fractures. Depending on its cost-effectiveness, zoledronate could be considered a first-line option for people at increased risk of fragility fractures. © 2022 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

Acceptability of, and preferences for, remote consulting during COVID-19 among older patients with two common long-term musculoskeletal conditions: findings from three qualitative studies and recommendations for practice.

BACKGROUND: Guidance for choosing face-to-face vs remote consultations (RCs) encourages clinicians to consider patient preferences, however, little is known about acceptability of, and preferences for RCs, particularly amongst patients with musculoskeletal conditions. This study aimed to explore the acceptability of, and preferences for, RC among patients with osteoporosis and rheumatoid arthritis. METHODS: Three UK qualitative studies, exploring patient experiences of accessing and receiving healthcare, undertaken during the pandemic, with people with osteoporosis and rheumatoid arthritis. Study team members agreed a consistent approach to conduct rapid deductive analysis using the Theoretical Framework of Acceptability (TFA) on transcripts from each data set relating to RC, facilitated by group meetings to discuss interpretations. Findings from the three studies were pooled. RESULTS: Findings from 1 focus group and 64 interviews with 35 people were included in the analysis. Participants' attitudes to RC, views on fairness (ethicality) and sense-making (intervention coherence) varied according to their needs within the consultation and views of the pandemic. Some participants valued the reduced burden associated with RC, while others highly valued non-verbal communication and physical examination associated with face-to-face consults (opportunity costs). Some participants described low confidence (self-efficacy) in being able to communicate in RCs and others perceived RCs as ineffective, in part due to suboptimal communication. CONCLUSIONS: Acceptability of, and preferences for RC appear to be influenced by societal, healthcare provider and personal factors and in this study, were not condition-dependant. Remote care by default has the potential to exacerbate health inequalities and needs nuanced implementation.

PERFECTED enhanced recovery pathway (PERFECT-ER) versus standard acute hospital care for people after hip fracture surgery who have cognitive impairment: a feasibility cluster randomised controlled trial.

OBJECTIVES: Assess feasibility of a cluster randomised controlled trial (RCT) to measure clinical and cost-effectiveness of an enhanced recovery pathway for people with hip fracture and cognitive impairment (CI). DESIGN: Feasibility trial undertaken between 2016 and 2018. SETTING: Eleven acute hospitals from three UK regions. PARTICIPANTS: 284 participants (208 female:69 male). INCLUSION CRITERIA: aged >60 years, confirmed proximal hip fracture requiring surgical fixation and CI; preoperative AMTS ≤8 in England or a 4AT score ≥1 in Scotland; minimum of 5 days on study ward; a 'suitable informant' able to provide proxy measures, recruited within 7 days of hip fracture surgery. EXCLUSION CRITERIA: no hip surgery; not expected to survive beyond 4 weeks; already enrolled in a clinical trial. INTERVENTION: PERFECT-ER, an enhanced recovery pathway with 15 quality targets supported by a checklist and manual, a service improvement lead a process lead and implemented using a plan-do-study-act model. PRIMARY AND SECONDARY OUTCOME MEASURES: Feasibility outcomes: recruitment and attrition, intervention acceptability, completion of participant reported outcome measures, preliminary estimates of potential effectiveness using mortality, EQ-5D-5L, economic and clinical outcome scores. RESULTS: 282 participants were consented and recruited (132, intervention) from a target of 400. Mean recruitment rates were the same in intervention and control sites, (range: 1.2 and 2.7 participants/month). Retention was 230 (86%) at 1 month and 54%(144) at 6 months. At 3 months a relatively small effect (one quarter of an SD) was observed on health-related quality of life of the patient measured with EQ-5D-5L proxy in the intervention group. CONCLUSION: This trial design was feasible with modifications to recruitment. Mechanisms for delivering consistency in the PERFECT-ER intervention and participant retention need to be addressed. However, an RCT may be a suboptimal research design to evaluate this intervention due to the complexity of caring for people with CI after hip fracture. TRIAL REGISTRATION NUMBER: ISRCTN99336264.

Poor Attendance for bone densitometry in patients at high risk of subsequent fragility fractures.

Fracture Liaison Services (FLS) are considered the most effective model for the prevention of subsequent fractures however, the uptake of these services has shown to be suboptimal. 6,528 patients were identified and referred on for bone densitometry assessment over a 6 yr period, however, 21% of these patients did not attend, with a trend towards a higher re-fracture rate in those that did not attend compared to those that did. The presence of a fragility fracture increases the risk of further fractures. Fracture Liaison Services (FLS) are considered the most effective model for the prevention of subsequent fractures, although the uptake amongst patients invited for bone densitometry assessment has shown to be suboptimal. The UK has one of the most comprehensive numbers of FLS, however the proportion and characteristics of patients identified through the FLS that do not respond to bone densitometry invitation, in the UK, remains unclear. We report the 6 yr. findings from the Nottingham FLS. The Nottingham Fracture Liaison Service (N-FLS) systematically identifies those adults aged 50 yr. and older with fragility fractures presenting to the fracture clinic and where appropriate, arranges referral for bone densitometry assessment. Routine clinical data is collected onto the N-FLS database. Patient characteristics, between January 2012 and December 2017, were examined of those referred for bone densitometry examination, comparing those that attended to those that did not attend (DNA). Deprivation scores for each patient were calculated using the English indices of deprivation 2015 (1-Most deprived; 5- Least deprived). Follow up data was available for those attending from 2016 onwards, which allowed an assessment of re-fracture. Over the 6 yr period, 6,528 patients as identified by the N-FLS were referred on for bone densitometry assessment. 1,386 patients (21%) did not attend (DNA) for bone densitometry assessment. The proportion was similar for each of the years. High prevalence of non-attendance was in females [1032 patients (74%)] and the most deprived individuals [398 patients (29%), which were significant when compared to those that did attend, p=0.042]. 826 patients were referred in 2016. Median follow-up time was 2.46 yr. (IQR 0.16-3.00 yr.). 52 (7%) patients, in this group, sustained a subsequent fracture (35 patients in the group that did not attend for bone density assessment and 17 in those that attend, p=0.092). Nottingham FLS have identified patients with fragility fractures that are at high-risk of further fractures. Despite a dedicated FLS, 21% of those invited for bone densitometry assessment, did not attend for their appointment, over the 6 yr. period, similar proportion each year. There was a significantly higher proportion of those identified as 'most deprived' not attending for a bone densitometry, compared to those who attended. Sub-analysis in those aged 75 yr. and over, showed a high non-attendance in this group. Further qualitative studies are necessary to explore this patient group in detail, who remain at high risk of re-fracture.

Can an Ice-Cream Based Supplement Help Address Malnutrition in Orthogeriatric Patients?

Using a Plan-Do-Study-Act (PDSA) methodology, we describe our first cycle of a project using an ice-cream oral nutritional supplement (ONS ice-cream) to address malnutrition in older patients. A Scandishake-based® (Nutricia) vanilla flavored ice-cream was developed and piloted on a cohort of orthopedic patients over 3 days. All suitable patients were offered 100 g ice-cream portions (240 kcal/per portion). Acceptability and energy intake were our primary outcomes. Over 3 days, the ONS ice-cream was accepted in 77% (n = 27, median age, 75 years, IQR 12.5) of the times offered. Among these patients the average energy intake per day including the ONS ice-cream was 1006 kcal, a 41% increase in energy intake compared to an initial nutritional survey among the older orthopedic patients (714 kcal, p = 0.010). When surveyed 84% (n = 16) of patients stated they would have the ONS ice-cream again. An ONS ice-cream intervention to improve energy intake in older adults is feasible.

The management of patients admitted to hospital with vertebral fragility fractures: experience from a UK university hospital.

INTRODUCTION: Patients that require hospital admission for vertebral fragility fractures were older, multimorbid, frail, have cognitive impairment and were in severe pain. This study aimed to describe the hospital treatment received in one UK university hospital with the purpose of proposing what hospital services should look like. METHOD: This was an observational study of adults aged 50 years and over admitted to hospital over 12 months with an acute vertebral fragility fracture. Information was collected from patients and electronic health records on their presentation and hospital care. RESULTS: 90 patients were recruited into the study. 69% presented to hospital 24 h after the onset of their severe acute back pain. 38% had a concomitant medical diagnosis, such as an ongoing infection. X-ray of the spine was the most common imaging of choice to diagnose a fracture. There was variation in the content of the radiology reports. 46% or patients were managed on geriatric medicine wards, 39% on general medical wards, and followed by 14% on spinal surgical wards. Patients cared for by medical teams were older, frailer, had a higher prevalence of cognitive impairment, more dependent for daily living and less mobile compared to those under the care of the spinal surgical team. Many patients on medical wards had input from spinal surgical team and vice versa. 9% proceeded to have vertebral augmentation. Despite many in severe pain, only a third were prescribed opioids with the median dose of morphine-equivalent was 10-20 mg daily for the first three days of admission. While in hospital, 31% developed a medical complication, with infection being the most common one. On discharge, 76% still required opioids and only 56% had a plan for their bone health. DISCUSSION: Improvements could be made to hospital vertebral fracture care. Many did not receive adequate pain relief and appropriate assessments to reduce their future fall and fracture risk. Most were medically managed. Quality standards and re-organising care in hip fracture has led to improved outcomes. A similar approach in vertebral fragility fractures might also deliver improved outcomes.