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A retrospective analysis comparing a teriparatide biosimilar (RGB-10) with reference teriparatide for osteoporosis treatment in postmenopausal women at high fracture risk found them to be therapeutically equivalent. Both provided significant improvements in lumber spine BMD, TBS, and other parameters of bone health, assessed using multiple diagnostic methods., Purpose: To compare the therapeutic efficacy of a teriparatide biosimilar (RGB-10) with reference teriparatide for the treatment of osteoporosis in postmenopausal women at very high fracture risk., Methods: A retrospective analysis of 25 postmenopausal female patients treated for osteoporosis with RGB-10 for 24 months and a matched cohort of 25 patients treated with reference teriparatide. The following outcomes were assessed at baseline, 12 and 24 months: bone mineral density (BMD) at the lumbar spine, femoral neck and total hip using dual-energy x-ray absorptiometry (DXA) and integral, trabecular and cortical volumetric and surface BMD using 3D-SHAPER ® imaging, trabecular bone score (TBS), quantitative ultrasound (QUS) measurements, and high-resolution peripheral quantitative computed tomography (HRpQCT) imaging of the radius and tibia., Results: No significant differences were observed between treatment groups in any of the measured parameters of BMD or bone health at baseline as well as in any timepoint when assessed using these various diagnostic methods. Both compounds provided equivalent significant improvements from baseline in measures of osteoporosis and fracture risk., Conclusion: The results of the analysis demonstrate the therapeutic equivalence of the teriparatide biosimilar (RGB-10) to reference teriparatide for the treatment of osteoporosis in postmenopausal women at very high risk of fracture., Competing Interests: Declarations. Ethics approval and consent to participate: This study was performed in accordance with the Declaration of Helsinki as well as with local ethical requirements. All study subjects gave written consent to participate. Conflicts of interest: P. Hadji: Has received study, educational and travel support from Amgen, Elli Lilly, Gedeon Richter, STADA Arzneimittel AG, Theramex and UCB. L. Kamali: No conflicts of interest relevant to this work. F. Thomasius: Has received honoraria for consulting or lectures from Amgen, Fresenius, Gedeon-Richter, STADA Arzneimittel AG, Theramex and UCB. K. Horas: No conflicts of interest relevant to this work. A. Kurth: Has received fees as a scientific advisor for Amgen, Theramex, Merit Medical, AgNovos, UCB, Image Biopsie Lab and as a lecturer for Amgen, STADA Arzneimittel AG, UCB, Alexion, AgNovos, Hologic. N. Bock: No conflicts of interest relevant to this work., (© 2024. The Author(s).)

The overarching goal of osteoporosis management is to prevent fractures. A goal-directed approach to long-term management of fracture risk helps ensure that the most appropriate initial treatment and treatment sequence is selected for individual patients. Goal-directed treatment decisions require assessment of clinical fracture history, vertebral fracture identification (using vertebral imaging as appropriate), measurement of bone mineral density (BMD), and consideration of other major clinical risk factors. Treatment targets should be tailored to each patient's individual risk profile and based on the specific indication for beginning treatment, including recency, site, number and severity of prior fractures, and BMD levels at the total hip, femoral neck, and lumbar spine. Instead of first-line bisphosphonate treatment for all patients, selection of initial treatment should focus on reducing fracture risk rapidly for patients at very high and imminent risk, such as in those with recent fractures. Initial treatment selection should also consider the probability that a BMD treatment target can be attained within a reasonable period of time and the differential magnitude of fracture risk reduction and BMD impact with osteoanabolic versus antiresorptive therapy. This position statement of the ASBMR/BHOF Task Force on Goal-Directed Osteoporosis Treatment provides an overall summary of the major clinical recommendations about treatment targets and strategies to achieve those targets based on the best evidence available, derived primarily from studies in older postmenopausal women of European ancestry., (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Society for Bone and Mineral Research.)

In September 2023, the guideline on the prophylaxis, diagnosis, and treatment of osteoporosis in postmenopausal women and men was published as a completely revised guideline. The implications for practice include a change in the justifying indication for performing a bone density measurement, the time interval over which the fracture risk is determined, the level and number of therapy thresholds, and the recommendations for the therapeutic approach that are adapted to the individual fracture risk present. Risk assessment for the prediction of spine and hip fractures is essential in the context of osteoporosis diagnostics. In addition to age and gender, there are a total of 33 risk factors to determine the individual risk of fracture. Much more attention is paid to the assessment of the risk of falls and, depending on the result, combined with recommendations for muscle training and protein intake from the age of 65. Risk indicators must also be taken into account when determining the indication for osteoporosis diagnosis, as well as the risk factors of the imminent risk of fracture. The indication for baseline diagnostics has changed from the >20% 10-year fracture risk to diagnostics in postmenopausal women and in men aged 50 years and older, depending on the fracture risk factor profile. This eliminates a specific fracture risk threshold for basic diagnostics. Thus, in the young patient group (50-60 years), the risk factors considered medically relevant for the indication for osteoporosis diagnosis must be taken into account. New thresholds as an indication for initiating therapy is the determination of fracture risk using a risk calculator over 3 years instead of 10 years. The indication for drug therapy should be based on the threshold values of the DVO risk model. The data clearly suggests a significantly faster and more effective fracture risk-reducing effect of anabolic therapy. This is recommended in the first sequence in cases of a very high risk of fracture from 10%/3 years with osteoanabolic active substances (teriparatide or romosozumab). Such a therapy sequence should be initiated directly and not delayed due to upcoming dental procedures. Follow-up therapy to consolidate the reduction of fracture risk should be chosen individually., Competing Interests: Dr. Friederike Thomasius gibt folgende Interessenskonflikte an: Koordinatorin der Leitlinienkommission des DVO. Prof. Dr. Heide Siggelkow gibt folgende Interessenkonflikte an: Mitglied der Leitlinienkommission des DVO., (Thieme. All rights reserved.)

Purpose: The primary objective of the present systematic review and meta-analysis was to determine the effect of differing exercise intensity on (areal) bone mineral density (BMD) at lumbar spine and hip in adults by a comparative meta-analysis., Methods: A systematic review of the literature according to the PRISMA statement included: (a) exercise trials, (b) with ≥two study arms that compared different exercise intensities, (c) intervention ≥6 months, (d) BMD assessments at lumbar spine (LS) or hip. Five electronic databases were scanned without language restrictions up to July 2021. The present analysis of exercise intensity was conducted as a mixed-effect meta-analysis and applied "type of exercise" and "study duration" as moderator in subgroup analyses. Outcome measures were standardized mean differences (SMD) for BMD changes at the LS, and hip., Results: Eleven exercise studies with 26 study arms were included. Although the effect of high-intensity exercise was more pronounced on LS-BMD (SMD: 0.19, 95%-CI: 0.61 to -0.23) and hip-ROI (0.17, 0.38 to -0.04), we did not observe significant differences between the groups (LS-BMD: p=0.373 and hip-BMD: p=0.109). We observed a substantial level of heterogeneity between the trials for LS- but not for hip-BMD. Applying "type of exercise" and "study duration" as moderators did not significantly modify the differences between low and high exercise intensity on BMD at LS or hip., Conclusion: There is insufficient evidence for a superior effect of high-intensity exercise on areal BMD at lumbar spine and hip in people aged 50 years and older. Varying exercise intensity with periods of lower exercise intensity intermitted by higher intensity might be a promising option to address the issue of exercise intensities in intervention studies., (© 2022. The Author(s).)

Context: There is some evidence that an adequate "anabolic hormonal milieu" is essential for the mechanosensitivity/transduction/response of bone tissue., Objective: This work aimed to determine whether enhancing hormone therapy (HT) with exercise increases the isolated effect of HT on bone mineral density (BMD) at the lumbar spine (LS) and femoral neck (FN)., Methods: A comprehensive search of 6 electronic databases according to the PRISMA statement up to April 28, 2021, included controlled trials longer than 6 months with 3 study arms: (a) HT, (b) exercise, and (c) HT plus exercise (HT + E). Apart from HT, no pharmaceutic therapy or diseases with relevant osteoanabolic or osteocatabolic effect on bone metabolism were included. The present analysis was conducted as a random-effects meta-analysis. Outcome measures were standardized mean differences (SMD) for BMD changes at the LS and FN., Results: Our search identified 6 eligible studies (n = 585). Although the effect of HT + E was more pronounced in the LS (SMD: 0.19; 95% C,: -0.15 to 0.53) and FN-BMD (0.18; -0.09 to 0.44) compared to the HT group, we did not observe significant differences between the 2 groups. We observed a low (I2: 29%) or moderate (I2: 49%) level of heterogeneity between the trials for FN or LS., Conclusion: We do not observe a significant effect of HT + E vs HT alone. We largely attribute this result to varying HT supplementation and hormonal status. Bearing in mind that synergistic/additive effects between HT and mechanical stimulation can only be expected in situations of hormonal insufficiency, further clinical studies should consider baseline endogenous estrogen production but also HT dosing more carefully., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Summary: There has been concerning about women receiving depot medroxyprogesterone acetate (DMPA) contraception because of the prolonged hypoestrogenemic state regarding the potential negative effects on bone health. This study showed that DMPA exposure is associated with increased fracture risk and that fracture risk increases with longer DMPA exposure. Introduction: DMPA has been associated with impaired bone mineral acquisition during adolescence and accelerated bone loss in later life. We performed this large population-based study to assess the association between use of DMPA or combined oral contraceptives and the incident risk of fracture. Methods: We identified 4189 women between 20 and 44 years of age with a first-time fracture diagnosis, matched them with 4189 random controls using the Disease Analyzer database and investigated the relation with DMPA exposure. Results: Overall, 11 % of the fracture cases and 7.7 % of the controls had DMPA use recorded. The adjusted OR for developing a fracture in patients with current use of DMPA compared to non-users was 0.97 (95 % CI 0.51-1.86), 2.41 (95 % CI 1.42-4.08), and 1.46 (95 % CI 0.96-2.23) for 1-2, 3-9, and ≥10 prescriptions, respectively. The adjusted OR for developing a fracture in patients with past use of DMPA compared to non-users was 0.96 (95 % CI 0.73-1.26), 1.14 (95 % CI 0.86-1.51), and 1.55 (95 % CI 1.07-2.27) for 1-2, 3-9, and ≥10 prescriptions, respectively. The highest fracture risk was identified in young patients less than 30 years with longer DMPA exposure (≥10 prescriptions; OR 3.04, 95 % CI 1.36-6.81), as well as in patients in the late reproductive years with past use of DMPA (OR 1.72, 95 % CI 1.13-2.63). Conclusions: Our results indicate that DMPA exposure is associated with increased fracture risk and may have negative effects on bone metabolism, resulting in impaired bone mineral acquisition during adolescence and accelerated bone loss in adult life. [ABSTRACT FROM AUTHOR]