Efficacy and safety of COVID-19 vaccines for patients with spinal tumors receiving denosumab treatment: An initial real-clinical experience study.

Background: Even if COVID-19 vaccine has gradually been adopted in the world, information of side effects and crosstalk in patients with spinal tumors is absent due to the exclusion from clinical research. In this research, we aimed to investigate the efficacy and safety for the patients with spinal tumors treated by denosumab. Methods: In this retrospective research, 400 patients under treatment of denosumab against spinal tumors in real-clinical experience were grouped into two cohorts according to the treatment of COVID-19 vaccine. And linked hospital data, serum samples and unsolicited related adverse events had been collected from January 22nd 2021 to June 1st 2021 respectively. Results: 233 patients of all participants who received regular treatment of denosumab were vaccinated by mRNA or inactivated vaccine. Patients of metastatic disease and primary osseous spinal tumor showed similar distribution in both two groups. Over the study period, within 176 patients tested the status of serologic response of vaccine, 88(81.48%) and 41(87.23%) individuals injected one or two inactivated vaccines had effective antibody against SARS-CoV-2 infections. As 21 patients (85.71%) treated by mRNA vaccine did. Considering of the safety of vaccine, most common systemic adverse events were nausea or vomiting (45 events vs 23events). Interestingly, fewer participants in the vaccine group were statistically recorded in local adverse events than in the placebo group (16 events vs 33 events). Conclusions: Our initial real-clinical experience suggests that COVID-19 vaccines are likely safe and effective in in patients with spinal tumors receiving denosumab treatment.

When and how to stop denosumab therapy in a patient with osteoporosis.

Denosumab is a human monoclonal antibody that competitively inhibits the receptor activator of nuclear factor kappa B ligand which regulates osteoclast activity. It is an effective treatment for osteoporosis with a reduced cumulative rate of vertebral fractures, hip and nonvertebral fractures as well as an increase in bone mineral density. The benefits have been shown to be maintained when treatment is continued up to and likely after 10 years of therapy, but the effects are lost rapidly if treatment is discontinued abruptly. There are rare medical indications for discontinuation of treatment. Discontinuation of denosumab is often driven by concern about complications such as osteonecrosis of the jaw, atypical femoral fractures and hypocalcaemia, which remain rare events. Further studies are required to confirm safety and efficacy beyond 10 years of treatment, but it is likely that patients will have ongoing benefits from therapy beyond this. We aim to present a personal perspective of why and how denosumab should be discontinued in patients with osteoporosis.

Discontinuing Denosumab: Can It Be Done Safely? A Review of the Literature.

Denosumab, which has been approved for the treatment of osteoporosis since 2010, is a fully humanised monoclonal antibody against a cytokine, receptor activator of nuclear factor kappa B ligand (RANKL), involved in bone resorption. Continued use of denosumab results in a potent and sustained decrease in bone turnover, an increase in bone mineral density (BMD), and a reduction in vertebral and hip fractures. The anti-resorptive effects of denosumab are reversible upon cessation, and this reversal is accompanied by a transient marked increase in bone turnover that is associated with bone loss, and of concern, an increased risk of multiple vertebral fractures. In this review, we outline the effects of denosumab withdrawal on bone turnover markers, BMD, histomorphometry, and fracture risk. We provide an update on recent clinical trials that sought to answer how clinicians can transition away from denosumab safely with follow-on therapy to mitigate bone loss and summarise the recommendations of various international guidelines.

Comprehensive conservative treatment for multiple metastases of skull osteosarcoma: A case report.

Background: Skull osteosarcoma is relatively rare, and it is difficult to be diagnosed according to medical history and imaging examination due to the complex structure and diverse components of the brain. Consequently, there is only a limited number of patients who can undergo neoadjuvant chemotherapy before the operation. Although neoadjuvant chemotherapy plays an important role in the treatment of osteosarcoma, there is still a "bottleneck" in the current treatment method which when pulmonary metastasis occurs, or surgical treatment is not Enneking appropriate. Under such circumstances, the choice of treatment can be an issue. Case: A 16-year-old male patient with multiple metastases of skull osteosarcoma was reported. The patient suffered not only tinnitus and hearing loss in the right ear but also right facial paralysis and headache. The preoperative brain MRI showed a tumor in the right cerebellopontine angle (CPA) area. He underwent skull tumor resection at another hospital in November 2018, during which process the biopsy revealed epithelioid osteoblastoma-like osteosarcoma. The patient had supplemental radiotherapy 1 month after surgery because of tumor recurrence. 32 months afterward, pulmonary metastases and multiple bone metastases were found. Then the patient underwent multiple conservative treatments which include Denosumab, Anlotinib, and DIA (cisplatin + ifosfamide + doxorubicin) chemotherapy at our hospital. After a series of 6 cycles of treatment, the patient can walk without aid. Lactate dehydrogenase (LDH) and Alkaline phosphatase (AKP) returned to a normal level. Fluorodeoxyglucose (FDG) metabolism in all bone metastases decreased to normal except for the ones in the proximal left femur, and the FDG metabolism in the left femur is significantly lower than that before treatment. Multiple bone metastases showed different extents of high-density calcification, and the volume of the local bone metastases has been reduced significantly. The patient's condition stayed stable at latest follow-up. Conclusion: We found that multiple conservative treatments, which include Denosumab, Anlotinib and DIA chemotherapy, can improve patients' life quality, and help avoid further osteolytic destruction for patients with skull osteosarcoma and multiple metastases. Its specific mechanism and scope of the application still need to be further studied.

Anti-osteoporosis medication dispensing by clinical commissioning groups in England - an ecological study of variability in practice and of the effect of the Covid-19 pandemic.

PURPOSE: To investigate whether the rate of Anti-Osteoporosis Medication (AOM) dispensing was related to prevalence of risk factors and hip fracture incidence in the local population. METHODS: The Open Prescribing database was used to analyse dispensed AOM at the level of Clinical Commissioning Groups (CCGs) in England. Male Healthy Life Expectancy (MHLE), Female Healthy Life Expectancy (FHLE), the prevalence of smoking and active adults, the incidence of hip fracture and of alcohol related hospital admissions, and local dispensing of a comparator drug (atorvastatin) were considered as predictor variables. Linear and multilinear regression were performed. Using atorvastatin as a comparator, AOM dispensing was compared after the start of the Covid-19 pandemic with the same quarter the previous year. RESULTS: Rates of AOM per 1000 people aged over 65 years in a CCG area varied between 379.2 and 1129.1, with a mean of 670.3. Population risk factors were individually related to the amount of AOM dispensed in an area. Collectively, local activity levels in adults (p = 0.042) and local hip fracture incidence (p = 0.003) were significantly negatively correlated with rates of AOM dispensed. Rates of alendronate dispensing fell significantly at the start of the Covid-19 pandemic (p < 0.001), whilst atorvastatin dispensing rates significantly increased (p < 0.001). CONCLUSION: Lower rates of AOM dispensing were seen in areas with a higher proportion of active adults and higher incidence of hip fracture. Multidisciplinary services should be developed to address this care gap with consideration given to local population risk factors. Community pharmacists are ideally placed to play a vital role in osteoporosis management.

Changes in dispensing of anti-osteoporotic drugs during COVID-19 pandemic

Care of osteoporosis patients during COVID-19 pandemic is challenging. Due to lockdowns and restrictions, the management of osteoporosis has changed. Diagnosis of osteoporosis decreased and the influence of COVID-19 on drug prescriptions and dispensing is currently unclear. Therefore, the aim of the study was to assess the dispensing of anti-osteoporotic drugs during the Covid19 pandemic. Methods This study was a nationwide retrospective register-based observational study which included all patients in Austria aged >= 50 who received at least one prescription for anti-osteoporotic drug between January 2016 and November 2020. Pseudonymized individual-level patients' data were obtained from social insurance authorities and the Federal Ministry of Labour, Social Affairs, Health and Consumer Protection in Austria. Anti-osteoporotic agents were divided into: (i) oral bisphosphonates, (ii) intravenous bisphosphonates, (iii) selective estrogen receptor modulators (SERMs), (iv) teriparatide (TPTD) and (v) Denosumab (DMAB). We used interrupted time series analysis with autoregressive integrated moving average models (ARIMA) for the prediction of drug dispensing. Results There were 2,884,627 dispensing of anti-osteoporotic drugs by 318,573 patients between 2016-2020. The mean monthly prescriptions for oral bisphosphonates (-14.5 %) and SERMs (-12.9 %) decreased during COVID-19 pandemic, compared to the non-COVID-19 period. The dispensing for intravenous bisphosphonates (1.7 %) and teriparatide (9.5 %) increased during COVID- 19. The prescriptions for DMAB decreased during the first lock-down in March and April 2020 (24 %), however increased by 29.1 % for the total observation time. The ARIMA model for alendronate showed, that the estimated step change was minus 1443 dispensing (95 % CI - 2870 to - 17), while the estimated change in slope was minus 29 dispensing per month (95 % CI - 327 to 270). Thus, there were 1472 (1443 + 29) fewer dispensing in March 2020 than predicted had the lockdown not occurred. Discussion The total number of prescriptions dispensed to patients treated with anti-osteoporotic medications declined rapidly during the first COVID-19 lockdown. The largest drops in absolute terms were observed for ibandronate, followed by alendronate, denosumab, zolendronic acid and risendronate. The observed decrease of DMAB during the first lockdown, was compensated in the following months. Current evidence suggests no need for discontinuation of anti-osteoporotic drugs during COVID-19 pandemic, nor because of vaccination. Taking into account the massive treatment gap for osteoporosis, and the related fracture risk, clinicians should continue treatment, even in times of pandemics.

Delivering essential care services during COVID lockdowns: GP experiences and approaches

Background: While the UK's Royal College of General Practitioners developed guidance concerning the delivery of essential services during the COVID pandemic, no such guidance was available in Australia and little is known about the experiences or approaches taken by general practitioners (GPs) for the delivery of care in Australia. Aims/Objectives: To describe GPs' experiences and approaches to delivering essential clinical services (ECS) during COVID lockdowns. Method(s): A survey of GPs who had practiced during lockdowns in Melbourne and Sydney. Questions focused on changes made to care delivery including what services were continued: (1) regardless of outbreak scale, (2) if capacity allowed, or (3) postponed. Finding(s): Of 274 completed surveys, 95% of participants reported increased use of telehealth for diagnosis, investigation, and management of clinical conditions, and 97% for follow-up. Time-sensitive services such as provision of care for symptoms consistent with cancer or those with immediate health impact (e.g., immunisations, prolia injections) were generally continued even if requiring face-to face delivery. Consultations involving screening or health assessments or those necessitating face-to-face care but not clinically urgent (e.g., low risk cervical cancer screening and IUD insertions), were more likely to be postponed, as were visits to homebound and nursing home patients. Implications: The almost universal uptake of telehealth by GPs supported continuity of service provision during lockdown. Australian GPs acted autonomously to triage and provide ECS face to face through the lockdowns. To optimise future preparedness, local guidance for safe delivery of ECS must be developed considering contextual factors relevant to the Australian primary healthcare system.

Abstracts of the Joint Annual Meeting of the Swiss Society of Rheumatology and the Swiss Society of Physical Medicine and Rehabilitation

The proceedings contain 47 papers. The topics discussed include: increased humoral immune response after vaccination with mRNA-1273 vs BNT162b2 in patients with inflammatory rheumatic diseases;comparison of anti-fracture effectiveness of denosumab versus bisphosphonates in a registry-based, real-world cohort study;comparison of drug retention of TNF inhibitors, other biologics and JAK inhibitors in patients with rheumatoid arthritis who discontinued JAK inhibitor therapy;BRD3 regulates the inflammatory and stress response in rheumatoid arthritis synovial fibroblasts;effect of methotrexate and folic acid co-administration in arthritis;early anti-S antibody levels predict anti-SARS-CoV-2 neutralizing activity over 24 weeks in RA patients after SARS-CoV-2 mRNA vaccination;effect of zoledronate on bone mineral density and bone turnover markers after long-term denosumab therapy: observations in a real-world setting;and developing a screening tool for the detection of interstitial lung disease in systemic sclerosis: the ILD-RISC score.

REGRESSIVE BONE MINERAL DENSITY TRENDS SEEN with DELAY in FOLLOW UP of DENOSUMAB TREATMENT DUE to the PANDEMIC INDUCED LOCKDOWN-A SINGLE CENTRE INDIAN EXPERIENCE

Background: Denosumab (Dmab), a fully human monoclonal antibody that inhibits receptor activator of nuclear factor kappa-β ligand (RANKL), which selectively inhibits osteoclastogenesis can be used for a long period unlike the relatively short period with Teriparatide.1-2 However the effects of Dmab can quickly regress if the treatment is delayed.3 Objectives: The pandemic led to multiple prolonged lockdowns since March 2020 to Jan 2022 in India. This resulted in follow up Dmab treatment delays. The retrospective study was aimed to look for the effect of the delays. Methods: The bone mineral density (BMD) trends from the central dual-energy X-ray absorptiometry (DXA) at our centre were studied. The trends of patients under Dmab for one year and delay in follow up for 10-12 months for the forth dose were evaluated. 21 postmenopausal women who had been under treatment with Dmab 60 mg subcutaneous injection at 6 monthly interval for one year followed up with such delays. 6 were excluded because of history of sars-cov-2 infection and glucocorticoid use. In the study group of 15 (n=15), the mean BMD at L2, L3 & L4 (sp BMD) and Right and Left Hip (hip BMD) were studied from before treatment (a BMD), 6 months after 1st and at the time of 2nd injection (b BMD), 6 months of the 2nd and at the time of 3 rd injection of Dmab (c BMD), and that due to delay in follow up of 10-12 months (d BMD). The mean percentage trend change between a-b, b-c, and c-d BMDs was evaluated. The least signifcant change (LSC) 4 from a single centre DXA was used to validate the fndings. Results: The mean percentage change after the treatment for the 1st 6 months of Dmab (a-b BMD) was 4.08% and 3.60% and the second injection resulted in a further change (b-c BMD) of 5.98% and 4.52% in the sp BMD & hip BMD respectively. The delay in follow up of 10-12 months resulted in a change (c-d BMD) of-7.81% in the sp BMD and-2.96% in the hip BMD. The LSC from a single centre DXA is 2.6% and 3.6% for sp BMD and hip BMD respectively. A p>0.05 was considered statistically signifcant. Table 1 shows the BMD changes. Conclusion: These fndings suggest that regressive trend in BMD are seen when the treatment with Dmab is delayed even as early as 10 to 12 months. It was seen much faster in the spine compared to the hip. It is therefore advised that short term treatment with Dmab without follow up could lead to loss of all gains and may also worsen the osteoporosis.

ANTIOSTEOPOROTIC TREATMENT and COVID-19 RISK: IS THERE AN ASSOCIATION?

Background: Nowadays, the COVID-19 and its complications are considered an important medical issue with aggravated medico-social outcomes, both at the worldwide scale, and in terms of various individual countries. Despite the recent ASBMR, AACE, Endocrine Society, ECTS and NOF recommendations according to osteoporosis management in the era of COVID-19 the influence of antios-teoporotic drugs on disease incidence and severity continue to be studied [1, 2]. Objectives: The purpose of this study was to assess the COVID-19 risk for the patients receiving the parenteral bisphosphonate or Denosumab treatment, and the severity of its course in the systemic osteoporosis patients. Methods: We performed the phone survey and studied the results of 195 patients (92 % women;mean age-62.7±10.8 years, height-161.0±8.0 cm, body weight-68.9±12.3 kg) with systemic osteoporosis depending on the current use of parenteral antiresorptive drugs (Zoledronic acid, Ibandronic acid, or Denosumab, n=125) and compared the results with patients with osteoporosis who did not use any antiosteoporotic drugs previously (n=70). The mean duration of antiosteoporotic treatment did not vary across the groups, accounting for 15 [9-27] months. Prior to the beginning of the antiosteoporotic therapy, all the patients had a confrmed diagnosis of osteoporosis at the Ukrainian scientific-medical Center of osteoporosis. Results: We did not reveal any signifcant differences in the COVID-19 frequency and severity depending on the presence and type of parenteral antiosteoporotic therapy. Additionally, there were no differences depending on patients' age of sex, obesity presence, and other osteoporosis risk factors. The risk of COVID-19 in the patients with systemic osteoporosis did not differ depending on antiresorptive drug use, amounting (Odd Ratio (OR) 95 % CI) to 1.1 (0.6-2.0), or on the use of the defnite antiosteoporotic drug (for the Zoledronic acid-0.9 (0.4-2.0), the Ibandronic acid-1. 1 (0.5-2.3), and for the Denosumab-1. 6 (0.5-5.2). Conclusion: Our study did not reveal any signifcant differences in the COVID-19 frequency and severity depending on the presence and type of parenteral antiosteoporotic therapy. We conclude that parenteral antiosteoporotic drugs (Zoledronic acid, Ibandronic acid, or Denosumab) do not have an influence on COVID-19 frequency and severity and can be recommended for the continuation of treatment of patients with osteoporosis.

IMPACT of the SARS-COV 2 PANDEMIC and RELATED EPIDEMIOLOGICAL RESTRICTIONS on the CARE of PATIENTS with OSTEOPOROSIS-EXPERIENCES of A HUNGARIAN CENTRE

Background: Treatment of patients with osteoporosis was inadequate even before the COVID-19 pandemic. Not only patients without fracture, but only a small proportion of patients with osteoporotic fracture have treated. In Hungary only 30% of patients with osteoporosis received adequate antiporotic treatment before the pandemic. Almost 90% of whom were women, less than 10% of men. The incidence of fractures is increasing dramatically worldwide. In 2010, the vertebral fracture rate was 3.5 million in Europe but it is expected to reach 4.5 million by 2025. In 1990, osteoporosis caused 1.26 million hip fractures and by 2025 this is estimated at 2.6 million worldwide. The care for patients with osteoporosis was further aggravated by the restrictions necessarily imposed due to the coronavirus. Objectives: The aim of the study was to explore the extent and consequences of diagnostic and therapeutic failure in patients with osteoporosis. Methods: I determined the number of osteoporosis examinations performed in our centre in 2019-2021 from the medical database. I surveyed how many patients were discontinued the antiporotic treatment during the pandemic according to the different drug groups in Hungary and also in our centre as well as the prevalence of wrist and hip fractures due to minor trauma in our county in the pre-and post-pandemic period. Results: In our centre an average of 30 DEXA examinations were performed daily in the pre-pandemic period. From the end of October 2021 to the end of May 2021 there was not perform any ODM examinations. It means 3.980 missed exams and at least 1.000 missed osteoporosis diagnoses and therapy starts. More than 20% of patient were lost from the antiporotic care in Hungary. Drop-out was mainly seen in patients treated with bisphosphonates. There were 20730 bisphosphonate-treated patient in 2019, 19813 in 2020 and 17315 in 2021. Antiporotic treatment was discontinued in 30% of patients treated with bisphosphonate+vitamin-D (7849 in 2019, 6950 in 2020, 5484 in 2021) or bisphosphonate+calcium+vitamin-D fxed combination products (3256-2876-2289). In our centre, the prescribing of bisphosphonates has also decreased more than half. Patients treated with iv. bisphosphonates were interrupted or switched to oral formulations. Denosumab therapy was continuous: 581 injections were prescribed in the 12 months before and 579 during the pandemic. However, no new treatment started. In case of teriparatide, the initiated therapies were continued and even the number of prescriptions increased. As a consequence, an increase in the occurrence of fractures due to minor trauma is expected. Although epidemiological restrictions in this regard, the curfew has had some positive effects. According to international data, the number of wrist fractures has almost halved, while the data for hip fractures are controversial. The decrease of wrist fractures can also be verifed in our county. The number of wrist fractures was 598 in April-May 2019, 393 in the same period in 2020, and 372 in 2021. After a signifcant reduction in hip fractures in 2020, there is already an upward trend in 2021 (470 in 2019, 358 in 2020, 393 in 2021). The real consequences of failure to treat osteoporosis are expected only after years. Conclusion: Missed doctor-patient appointments were associated with missed diagnoses and interruptions of ongoing treatments. Fear of the virus, immobilisation due to home office and curfews, lack of exercise, sun exposure, caused depressive symptoms, increased alcohol consumption and caloric intake are all increase the risk of osteoporosis. Thus, traditional risk factors for osteoporosis expanded with the direct effects and the introduced restrictions because of the pandemic.

COVID-19 HAD AN ADVERSE IMPACT on DENOSUMAB TREATMENT PROVISION-COMPARISON with PRE-PANDEMIC WAITING TIMES at A UK-BASED RHEUMATOLOGY DEPARTMENT

Background: Denosumab treatment is licensed for prevention of osteoporo-tic fractures. It can cause hypocalcaemia, so bone profile blood tests must be checked prior to treatment. In our department, we have a Standard that patients have blood tests within 1 month before their denosumab injection, and that they receive the injection within 1 month from its due date. A customized MS Access database to record this information and generate a date for the next dose was established in 2015 after a quality improvement project (QIP)1. At the onset of the COVID-19 pandemic, UK national guidance recommended continued provision of denosumab as an essential service. Objectives: 1. To re-audit delay from due date to actual injection date after establishment of our database. To compare delay from due date to actual injection date before and after onset of COVID-19. To compare the time between blood tests and actual injection date, before and after onset of COVID-19. Methods: Data for 2 time-periods were extracted from the database: Time Period 1 (pre-COVID-19) 01-03-2019-29-02-2020;Time Period 2 (post-COVID-19 onset) 01-03-2020-28-02-2021. For each patient attendance, dates of blood test, due date and actual injection date were extracted. All patient details were anonymised, with a decryption key to identifers held on a secure server at the host Trust. It was manually determined whether blood tests and injections were within 1 month of when they were due. Statistical analyses were carried out in Stata v.14.0. The Kolmogorov-Smirnov test was used to compare distributions between Time Periods 1 and 2. Results: TIME PERIOD 1: 100 appointments were audited from 68 patients. 20% of blood tests were within 1 month of actual injection date. Median time between blood tests and actual injection was 45 days [IQR 35-59]. 52% of actual injections were given within 1 month from due date. (This compares favourably with our 2015 QIP, when 40% of actual injections were within 1 month from due date1). Median time between due date and actual injection was 29.5 days [IQR 13-50.5]. TIME PERIOD 2: 77 appointments were audited from 66 individual patients. 24.7% of blood tests were within 1 month of actual injection. Median time between blood tests and actual injection was 45 days [IQR 35-59]. 16.6% of actual injections were given within 1 month of due date. Median time between due date and actual injection was 82 days [IQR 40-141]. There were no signifcant differences in time between blood tests and actual injection between Time Periods 1 and 2. However, the time between due date and actual injection date was signifcantly longer in Time Period 2 (p<0.005). Conclusion: The introduction of our customized database promoted an improvement in time between due date and actual injection date of denosumab. However, this improvement signifcantly declined after the onset of the COVID-19 pandemic. Resources may need to be increased and processes adapted to minimise the impact of future emergencies on denosumab provision.

Pros and Cons of Skeletal Medications in the COVID-19 Era.

Purpose of Review: This review provides an overview regarding osteoporosis therapies during the COVID-19 pandemic. Recent Findings: The COVID-19 pandemic has disrupted treatments for osteoporosis and resulted in decreased adherence particularly for parenteral regimens. Osteoporosis medications are safe and effective during the pandemic and should be continued whenever possible. Bisphosphonates have long-lasting effects on bone turnover such that delays in their administration are unlikely to be harmful to skeletal health. In contrast, interruption of denosumab treatment is strongly discouraged because of rapid loss of bone mass and an associated increased risk for rebound vertebral fractures. When osteoanabolic treatments cannot be continued during the pandemic, change to an oral bisphosphonate is advised. Preclinical data suggest possible beneficial effects of some therapies against COVID-19, but require validation in clinical studies. Vitamin D deficiency is associated with a more severe COVID-19 clinical course but data supporting improvements in outcomes with vitamin D supplementation are lacking. Summary: The impact of the COVID-19 pandemic on long-term bone health remains unknown but focused interventions to ensure osteoporosis treatment initiation/maintenance should be implemented. Future studies are needed to determine whether osteoporosis medications have an impact on SARS-CoV-2 pathophysiology and COVID-19 clinical outcomes.

PHARMACIST-LED OSTEOPOROSIS TELEPHONE SERVICE

Background/Aims The COVID-19 pandemic has made finding ways to consult suitable patients remotely a priority. We have introduced a telephone assessment clinic, run by our departmental pharmacist, to assess and treat patients with osteoporosis who have been referred from primary care for consideration of parenteral bone sparing therapy. Methods Patients with osteoporosis who have been referred from primary care were triaged electronically into a fortnightly telephone assessment clinic, according to pre-specified criteria. Prior to the appointment, information leaflets about osteoporosis, and treatments for this condition were posted to the patients. The telephone consultation was carried out and patient demographics, risk factors for fracture, bone density results, FRAX / NOGG assessment, treatment decisions, and other clinical details were recorded on a pro-forma. A satisfaction survey was sent out to each patient following consultation. Results Sixty patients were assessed between July 2020 and April 2021. Fiftyseven (95%) were female, and the mean age was 71 years. Following consultation, twenty-one were commenced on zoledronic acid, eighteen on denosumab, three on teriparatide and eighteen no treatments /other. Average time from referral to consultation was 1.75 months. Thirty-four patient satisfaction surveys were returned. Twenty-nine (85%) patients said they would be happy for consultations via telephone in the future, with twenty-five patients (74%) either likely or highly likely to recommend telephone consultation to family or friends. When asked to compare their experience of telephone to faceto- face consultations;twenty (58%) reported being indifferent, four (12%) said their experience was poorer or significantly poorer than face-to-face, and ten (29%) said their experience was better or significantly better. Mean saving on travel expenses was £0-£5 (41% of patients) with four patients (12%) saving £21+. Mean mileage saved was < 5 miles (33% of patients), with seven patients (21%) saving 30+ miles on travel. Conclusion This study reveals that patients, overall, had a positive experience with a pharmacist-led telephone consultation. Such clinics could be implemented across other areas of our rheumatology service, if clinically appropriate;reducing unnecessary patient contact, reducing consultant work load and optimally utilizing skills of the wider multidisciplinary team. Face-to-face consultations still have an essential role where physical examination may be required, or patients have communication barriers. Our sample size was small, and data collection is on-going.

Osteoporosis care during the COVID-19 pandemic

COVID-19 is an emerging infectious disease that has specific characteristics that interfere with the care of patients with osteoporosis. This article discusses the interfaces between osteological issues and COVID-19. A prevalent fracture very modestly increases the risk of death from COVID-19 but in hospitalized patients, the prevalence of vertebral fracture can be considered another aspect of polymorbidity increasing the likelihood of an adverse course of infection. Vitamin D deficiency correlates with worse outcomes in COVID-19, and sufficient vitamin D saturation is very likely protective in relation to COVID-19. Containment measures at the peak of the pandemic may result in muscle loss and increased risk of falls in the elderly. Densitometry and majority of laboratory tests can be easily delayed in patients with osteoporosis. This also applies to parenteral administration of bisphosphonates, whereas continuation of oral bisphosphonate therapy can be ensured by electronic prescription. Teriparatide should not be discontinued for more than 2–3 months, and the interval between denosumab administrations should not exceed 7 months.

Telemedicine in Patients with Fragility Fractures in the COVID-19 Era

Introduction: The covid19 pandemic has forced the health system to restructure to prevent contagion of our patients. In this context, the members of the Orthogeriatric Group of the Catalan Society of Geriatrics and Gerontology (SCGiG) created a document that collected all the considerations to take into account during the pandemic, based on the current guides and scientific societies, in order to perform a correct follow-up, enhance adherence and prevent future falls. Methods: A bibliographic review was performed, defining the key points in the care of the fractured patient through telemedicine (document is available at http://scgig.cat/docs/gt-orto-covid.pdf). Results: During hospital admission, antiosteoporotic treatment should be started, evaluating indications with the patient and family, to ensure adherence. Diet intake of calcium and vitamin D will be assessed. Discharge report includes evaluation of treatment and monitoring plan, to be useful for liaison nurse, rehabilitator and general practitioner. Six-monthly follow up is recommended for patients with comorbidities, polypharmacy, confusion, fall-risk, or parenteral anti-osteoporotic treatment. With denosumab or teriparatide, annual laboratory tests are recommended, with GFR <20, every six months, at home if possible. Bisphosphonates can be followed by the GP. Zoledronate is not recommended due to delayed administration after surgery, and possibility of transient flu-like simptoms. In the telematic follow-up visit, in patients undergoing zoledronic acid treatment, the new dose can be delayed for 6-12 months, without risk. Consider sequential treatment. Denosumab treatment cannot be delayed, so the patient and family will be trained in self-administration. Support materials from laboratories will be useful to patient and caregivers. Conclusion: Telemedicine is a good strategy for a follow-up, to avoid hospital contact, and starts on hospital admission. Patient and caregivers need access to new technologies and able to understand medical instructions.

A BRIEF SYNOPSIS OF MONOCLONAL ANTIBODY FOR THE TREATMENT OF VARIOUS GROUPS OF DISEASES.

Monoclonal antibodies (mAbs) are increasingly being prescribed to patients and investigated in the field of medicine and research. This class of medication is unique due to its ability to be engineered into targeting a specific receptor. Numerous studies and reviews have reported the efficacy, potency, and clinical usage of mAbs in the treatment of a variety of diseases ranging from autoimmune disorders to malignant cancers. However, very few publications classify and provide a brief synopsis of mAbs that includes their pharmacological profiles. mechanisms of action, uses, and side effects in a concise manner. Therefore, this review aims to classify the current mAbs drugs used in clinical practice according to system diseases by providing a brief summary for each of them. For example, regarding cardiovascular disorders, mAbs such as Abciximab, Bevacizumab, and Digoxin Immune Fab will be reviewed. Denosumab, used to treat musculoskeletal disorders, will be also discussed. In addition, mAbs such as Adalimumab, Eculizumab, Natalizumab used in autoimmune disorders and Alemtuzumab, Trastuzumab, Cetuximab, and Rituximab that are prescribed for tumors will be reviewed. Finally, we shall discuss two mAbs that are IL-6 antagonists, Tocilizumab and Siltuximab, which are in ongoing clinical trials as potential treatments of COVID-19. The mAbs have profound benefits against chronic and malignant conditions, and the overall purpose of this review is to illustrate the basic pharmacological profiles of mAbs that physicians may find useful in establishing their management protocols.

Self-injection of denosumab in clinical practice in the french pilote study

Objective: Describe characteristics of patients who self-inject denosumab and patterns of self-injection in France. Methods: PILOTE was a prospective observational study that evaluated persistence to denosumab over 24 months in France in postmenopausal women. Clinical information obtained through routine practice was recorded onto an eCRF, including the individual who injected subcutaneous denosumab (physician, nurse, patient, other). We conducted an ad hoc analysis of the patients in the study who self-injected denosumab. Results: In total, 478 patients were enrolled between June 2105 and February 2016. 27 patients self-injected denosumab at least once, with these patients distributed across multiple sites. Those who self-injected appeared slightly younger with longer duration of osteoporosis, and a higher proportion had a prior fracture and previous glucocorticoid and teriparatide treatment than the overall population (Table). Self-injected patients were also more likely to be living at home with family, have a University education, and be seen by a rheumatologist than a GP. Twelve patients self-injected from the beginning of the study, 15 self-injected after receiving injection from an HCP and 8 switched back to HCP injections after self-injection. Eleven of the 12 patients who self-injected from the beginning were persistent at 24 months. Six ADRs occurred in three self-injecting patients: one vertebral fracture, bone pain, muscle fatigue, myalgia, asthenia, pyelonephritis. Conclusion: Although numbers were small, self- administration of denosumab appeared feasible for women with postmenopausal osteoporosis and may be a valuable option, particularly in the context of the COVID-19 pandemic when office visits are restricted. (Table Presented).

Zolendronic acid after teriparatide: Pandemic observations

Objective: Teriparatide for sever osteoporosis is followed by antiresorptive drugs, and one option in patients with gastric intolerance is zolendronic acid or denosumab (1-5). During pandemic lockdown, the access to bone assessment was limited (1-5). Type 1 diabetic patients are particularly at risk for bone loss, but also for COVID-19 infection, thus the importance of respecting the pandemic rules (1-5). We aim to introduce a female case diagnosed with severe menopausal osteoporosis that was followed during post-teriparatide sequence of medication, including during pandemic days. Case report: This is a type 1 diabetic female of 77 y who was first diagnosed with menopausal osteoporosis 8 y ago (lumbar T-score of-3.1 SD) and started medication with weekly alendronate in addition to vitamin D supplements. After 3 y, she suffered a single spontaneous vertebral fracture thus teriparatide was initiated for 2 y (with good tolerance): lumbar T-score went from -3.1 to -1.9 SD. In the meantime, due to bilateral coxarthrosis she needed bilateral hip replacement. Further on, she continued with biannually denosumab for 8 injections, reaching a lumbar BMD-DXA 0.942 g/cm2, T-score of -2 SD, Z-score of -0.8 SD so an intravenous perfusion with zolendronic acid 5 mg was administered plus vitamin D supplements. While she had no additional fracture and glycated haemoglobin A1c remained around 6.2-6.4%, one year later, the pandemic started, so only bone turnover markers (BTM) were assessed, not DXA: suppressed CrossLaps=0.22 ng/mL (normal: 0.33-0.782 ng/ mL), osteocalcin=11 ng/mL (normal: 15-46 ng/mL), P1NP=27 pg/mL (normal: 15-45 pg/mL). She continued with vitamin D, and 20 months after injection CrossLaps remained low (=22 ng/mL) with normal osteocalcin (=15 ng/mL), P1NP (=28 pg/mL) and stationary BMD. Conclusion: Zolendronic acid effect in osteoporotic patients is easy to access by blood assays if DXA is not available, while lack of BTM increase is suggestive for a good outcome.