Development of outcome measures for giant cell arteritis for use in clinical trials and standard practice.

BACKGROUND: Developments in outcome measures in the rheumatic diseases are promoted by the development of successful treatments. Giant cell arteritis (GCA) is a multifaceted disorder and, therefore, measurement of multiple outcomes is relevant to this illness. It is a privilege to analyze and monitor/transfer long-term patients' management outcomes particularly if the same outcomes are used in practice and in trials. OBJECTIVE: To classify the outcome measures for GCA with a discriminative ability to identify the disease activity status and response to therapy. METHODS: This study was composed of two steps, instrument design (item generation) and judgmental evidence. A panel of 13 experts was used to validate the instrument through quantitative (content validity) and qualitative (cognitive interviewing) methods. Content validity index was used to assess content validity quantitatively. RESULTS: Five items achieved high content validity where item-content validity index score was >0.79, and in the meantime achieved high content validity response score reflecting greater agreement among panel members. Through qualitative methods, items were improved until saturation was achieved. This agreed with the expert panel ranking of the items included in GCA disease outcome measures set. CONCLUSION: For daily clinical practice, outcome measures should reflect the patients' disease activity status and have to be easily assessed and recorded. The study identified composite outcome measures for GCA able to assess the disease state and monitor response to therapy. Key Points • Despite the cohort studies published in giant cell arteritis (GCA), there are no fully validated outcome measures for use in standard practice or clinical trials. • There is a gap in international standards for assessing GCA disease activity. • Identifying disease specific outcome measures is vital for monitoring response to therapy, treatment case series and therapeutic clinical trials in GCA. • This study was carried out aiming to classify the outcome measures for GCA with a discriminative ability to identify the disease activity status and response to therapy.

Post-Fracture Care Program: Pharmacological Treatment of Osteoporosis in Older Adults with Fragility Fractures.

PURPOSE OF REVIEW: To present and discuss the recently published scientific evidence on the approach, mode of action, and timing of osteoporosis therapy initiation after fragility fractures. RECENT FINDINGS: A comprehensive management approach is required to reduce mortality and morbidity associated with fragility fractures. This will help to reduce the risk of missing the diagnosis of osteoporosis as the underlying disorder while at the same time promoting the timely treatment of osteoporosis. The target is to minimize the incidence of post-traumatic disability and to reduce the imminent fracture risk. This article will present a Bone-Care algorithm for the diagnosis and management of fragility fractures in patients presenting for trauma surgery. This algorithm has been developed based on recently published national as well as international guidelines for implementation in standard clinical practice. International figures revealed that only a small proportion of those patients at high risk of sustaining a fragility fracture receive osteoporosis therapy. Based on the best currently available evidence, it is safe to start osteoporosis therapy in the acute post-fracture period (the optimal therapeutic window of romosozumab is the late endochondral phase/throughout bone remodeling). The right Bone-Care pathway ensures the delivery of a comprehensive management approach that meets the global call to action. All parameters including risk, benefit, compliance, and cost should be considered on an individual base for all kinds of therapy.

Consensus Evidence-Based Clinical Practice Recommendations for the Diagnosis and Treat-To-Target Management of Osteoporosis in Chronic Kidney Disease Stages G4-G5D and Post-transplantation: An Initiative of Egyptian Academy of Bone Health.

Objective: The aim of this study was to reach a consensus on an updated version of the recommendations for the diagnosis and Treat-to-Target management of osteoporosis that is effective and safe for individuals with chronic kidney disease (CKD) G4-G5D/kidney transplant. Methods: Delphi process was implemented (3 rounds) to establish a consensus on 10 clinical domains: (1) study targets, (2) risk factors, (3) diagnosis, (4) case stratification, (5) treatment targets, (6) investigations, (7) medical management, (8) monitoring, (9) management of special groups, (10) fracture liaison service. After each round, statements were retired, modified, or added in view of the experts' suggestions, and the percent agreement was calculated. Statements receiving rates of 7-9 by more than 75% of experts' votes were considered as achieving consensus. Results: The surveys were sent to an expert panel (n = 26), of whom 23 participated in the three rounds (2 were international experts and 21 were national). Most of the participants were rheumatologists (87%), followed by nephrologists (8.7%), and geriatric physicians (4.3%). Eighteen recommendations, categorized into 10 domains, were obtained. Agreement with the recommendations (rank 7-9) ranged from 80 to 100%. Consensus was reached on the wording of all 10 clinical domains identified by the scientific committee. An algorithm for the management of osteoporosis in CKD has been suggested. Conclusion: A panel of international and national experts established a consensus regarding the management of osteoporosis in CKD patients. The developed recommendations provide a comprehensive approach to assessing and managing osteoporosis for all healthcare professionals involved in its management.

Is there a potential dual effect of denosumab for treatment of osteoporosis and sarcopenia?

BACKGROUND: The prevalence of sarcopenia with osteoporosis results in a higher risk of falling and fractures. It was noted that patients who had completed their planned 5-year denosumab therapy course as treatment for these conditions started to sustain falls. PURPOSE: To assess (a) whether denosumab has a unique dual effect on both bone and muscle in comparison to other anti-resorptive agents and (b) its effectiveness in the follow-up period post-treatment completion compared to other anti-resorptive agents. METHOD: One hundred thirty-five patients diagnosed to have postmenopausal/senile osteoporosis and who were prescribed denosumab were compared to a control group of 272 patients stratified into 2 subgroups - 136 prescribed alendronate and 136 prescribed zoledronate. All patients were assessed for: BMD (DXA), falls risk (FRAS), fracture risk (FRAX), and sarcopenia measures. All were re-assessed after 5 years of denosumab/alendronate therapy and 3 years of zoledronate and 1 year after stopping the osteoporosis therapy. RESULTS: No significant baseline demographic differences between the 3 groups. On completion of the 5-year denosumab therapy, there was significant decrease in falls risk (P = 0.001) and significant improvements in all sarcopenia measures (P = 0.01). One-year post-discontinuation of denosumab, a significant worsening of both falls risk and sarcopenia measures (P = 0.01) noticed. CONCLUSION: Denosumab displayed positive impact and significant improvements in BMD and sarcopenia measures. It also enhanced multidirectional agility as depicted by Timed Up and Go (TUG). Collectively, this would explain the reduction of falls risk which got worse on stopping the medication. Key points • The coexistence of osteoporosis and sarcopenia has been recently considered in some groups as a syndrome termed 'osteosarcopenia'. • Bone and muscle closely interact with each other not only anatomically, but also at the chemical and metabolic levels. • Denosumab displayed positive impact and significant improvements in all sarcopenia measures, and enhanced multidirectional agility with consequent reduction in falls risk. • Denosumab can be considered as a first osteoporosis therapeutic option in this group of patients presenting with osteosarcopenia manifestations.

Osteoporosis: not only in women, but in men too.

Osteoporosis is a chronic disease where the nurse specialist can make a significant impact. The osteoporosis nurse specialist has an important role, not only in the prevention and management of osteoporosis but also in the promotion of skeletal health across the public health and social care arenas and in the continuing development of services across primary and secondary care. The scale of the problem in women and the potential role of hormone replacement therapy in the prevention and treatment of osteoporosis has played down the problem of osteoporosis and osteoporotic fractures in men, thus facilitating a negligent attitude. This article summarizes the outcome of a dedicated male osteoporosis clinic, which was started by the lead clinicians in metabolic bone disease and falls and subsequently was run by the osteoporosis nurse specialist. A clinic proforma which can be used as a standard in clinical practice is presented. In addition, an algorithm for the management of men with osteoporosis is discussed.

Outcomes of a nurse-led osteoporosis and falls assessment.

Osteoporosis is a major public health concern. Recent evidence from clinical and epidemiological trials on osteoporosis has stressed the urgency for early and accurate diagnosis of vertebral fractures. Despite the fact that vertebral fractures are very common and associated with decreased quality of life, they are frequently missed in daily clinical practice. The authors developed a protocol to be applied through a specialized nurse-led osteoporosis vertebral fracture service that allows for accurate diagnosis, identifies patients at risk and shortens the time of assessment and management. A total of 114 patients have been reviewed over 12 months. Completing the referral form and the clinic proforma helped the nurse cover all causes of vertebral fractures and shortened the lag time for assessment and management. Osteoporosis therapy was commenced once diagnosis was confirmed.