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The Cochrane Database of Systematic... Jan 2017Corticosteroid treatment is considered the 'gold standard' for Duchenne muscular dystrophy (DMD); however, it is also known to induce osteoporosis and thus increase the... (Review)
Review
BACKGROUND
Corticosteroid treatment is considered the 'gold standard' for Duchenne muscular dystrophy (DMD); however, it is also known to induce osteoporosis and thus increase the risk of vertebral fragility fractures. Good practice in the care of those with DMD requires prevention of these adverse effects. Treatments to increase bone mineral density include bisphosphonates and vitamin D and calcium supplements, and in adolescents with pubertal delay, testosterone. Bone health management is an important part of lifelong care for patients with DMD.
OBJECTIVES
To assess the effects of interventions to prevent or treat osteoporosis in children and adults with DMD taking long-term corticosteroids; to assess the effects of these interventions on the frequency of vertebral fragility fractures and long-bone fractures, and on quality of life; and to assess adverse events.
SEARCH METHODS
On 12 September 2016, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL Plus to identify potentially eligible trials. We also searched the Web of Science ISI Proceedings (2001 to September 2016) and three clinical trials registries to identify unpublished studies and ongoing trials. We contacted correspondence authors of the included studies in the review to obtain information on unpublished studies or work in progress.
SELECTION CRITERIA
We considered for inclusion in the review randomised controlled trials (RCTs) and quasi-RCTs involving any bone health intervention for corticosteroid-induced osteoporosis and fragility fractures in children, adolescents, and adults with a confirmed diagnosis of DMD. The interventions might have included oral and intravenous bisphosphonates, vitamin D supplements, calcium supplements, dietary calcium, testosterone, and weight-bearing activity.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed reports and selected potential studies for inclusion, following standard Cochrane methodology. We contacted study authors to obtain further information for clarification on published work, unpublished studies, and work in progress.
MAIN RESULTS
We identified 18 potential studies, of which two, currently reported only as abstracts, met the inclusion criteria for this review. Too little information was available for us to present full results or adequately assess risk of bias. The participants were children aged five to 15 years with DMD, ambulant and non-ambulant. The interventions were risedronate versus no treatment in one trial (13 participants) and whole-body vibration versus a placebo device in the second (21 participants). Both studies reported improved bone mineral density with the active treatments, with no improvement in the control groups, but the abstracts did not compare treatment and control conditions. All children tolerated whole-body vibration treatment. No study provided information on adverse events. Two studies are ongoing: one investigating whole-body vibration, the other investigating zoledronic acid.
AUTHORS' CONCLUSIONS
We know of no high-quality evidence from RCTs to guide use of treatments to prevent or treat corticosteroid-induced osteoporosis and reduce the risk of fragility fractures in children and adults with DMD; only limited results from two trials reported in abstracts were available. We await formal trial reports. Findings from two ongoing relevant studies and two trials, for which only abstracts are available, will be important in future updates of this review.
Topics: Adolescent; Adrenal Cortex Hormones; Bone Density; Bone Density Conservation Agents; Calcium; Child; Child, Preschool; Diphosphonates; Humans; Imidazoles; Male; Muscular Dystrophy, Duchenne; Osteoporosis; Osteoporotic Fractures; Randomized Controlled Trials as Topic; Risedronic Acid; Spinal Fractures; Vibration; Vitamin D; Weight-Bearing; Zoledronic Acid
PubMed: 28117876
DOI: 10.1002/14651858.CD010899.pub2 -
Scientific Reports Dec 2019Despite the high prevalence of osteoporosis in liver cirrhosis, the indication of bisphosphonates for patients with esophageal varices has been avoided due to risk of... (Clinical Trial)
Clinical Trial
Despite the high prevalence of osteoporosis in liver cirrhosis, the indication of bisphosphonates for patients with esophageal varices has been avoided due to risk of digestive mucosal damage. Therefore, this study aimed to evaluate the safety profile of risedronate treatment for patients with osteoporosis, liver cirrhosis and esophageal varices with low risk of bleeding. A total of 120 patients were allocated into two groups according to their bone mineral density measured by dual-energy X-ray absorptiometry. In the intervention group, 57 subjects with osteoporosis received oral risedronate at 35 mg weekly plus daily calcium and vitamin D supplementation. In the control group, 63 subjects with osteopenia received only calcium and vitamin D. The groups received the treatment for one year and underwent surveillance endoscopies at six and 12 months, as well as a control dual-energy X-ray absorptiometry after a 12-month follow-up. The study received Institutional Review Board approval. The groups had not only comparable Model for End-stage Liver Disease score and esophageal varices degree, but also similar incidence of digestive adverse effects. A significant improvement was achieved in the intervention group in the lumbar spine T score (p < 0.001). The results suggest that risedronate may be safely used in liver cirrhosis and esophageal varices with low bleeding risk under endoscopic surveillance, thus allowing bone mass recovery.
Topics: Absorptiometry, Photon; Adult; Aged; Calcium; Esophageal and Gastric Varices; Female; Follow-Up Studies; Humans; Liver Cirrhosis; Male; Middle Aged; Osteoporosis; Prospective Studies; Risedronic Acid; Vitamin D
PubMed: 31831865
DOI: 10.1038/s41598-019-55603-y -
International Journal of Surgery... Apr 2018To examine the effects of risedronate for reducing periprosthetic bone loss after total hip arthroplasty (THA). (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To examine the effects of risedronate for reducing periprosthetic bone loss after total hip arthroplasty (THA).
METHODS
Two reviewers performed an electronic literature search for randomized controlled trial (RCTs) evaluating the risedronate in the management of periprosthetic bone loss after primary THA. The electronic databases include PubMed, Medline, Embase, Web of Science and the Cochrane Library from inception to January 2018. We assessed the risk of bias using the Cochrane risk-of-bias tool. STATA 14.0 was used to perform the meta-analysis.
RESULTS
Four RCTs were included in our study. Current meta-analysis indicated that postoperative reduciton of periprosthetic BMD in the risedronate group was significantly lower than that in the placebo group in zones 1, 2, 3, 4, 6, and 7. There was no increased risk of adverse effects.
CONCLUSION
The administration of risedronate was associates with a significantly improved periprosthetic BMD after primary THA. No increased risk of adverse events were observed. Higher quality RCTs are still required for further research.
Topics: Arthroplasty, Replacement, Hip; Bone Density; Bone Density Conservation Agents; Bone Resorption; Humans; Postoperative Complications; Risedronic Acid
PubMed: 29448032
DOI: 10.1016/j.ijsu.2018.02.007 -
BioMed Research International 2019The present study aimed to enhance the anti-osteoporotic performance of bioactive glass (46S6) through its association with bisphosphonate such as risedronate with...
The present study aimed to enhance the anti-osteoporotic performance of bioactive glass (46S6) through its association with bisphosphonate such as risedronate with amounts of 8, 12, and 20%. Obtained composites have been called 46S6-8RIS, 46S6-12RIS, and 46S6-20RIS, respectively. In vitro and in vivo explorations have been carried out. Bioactive glass and risedronate association has been performed by adsorption process. Structure analyses have been carried out to evaluate and to understand their chemical interactions. Solid Nuclear Magnetic Resonance (NMR) has been employed to study the structural properties of obtained biocomposite. The spectra deconvolution showed the appearance of a species ( ) in the biocomposites 46S6-8RIS, 46S6-12RIS, and 46S6-20RIS indicating their successful chemical association. In vitro experiments showed the enhancement of the chemical reactivity of the composites 46S6-xRIS compared to the pure bioactive glass. In fact, the silicon liberation after 30 days of immersion was 50 ppm for pure bioactive glass 46S6, and 41, 64, and 62 from 46S6-8RIS, 46S6-12RIS, and 46S6-20RIS, respectively. Based on the in vitro results, 46S6-8RIS was implanted in the femoral condyle of an ovariectomized rat and compared with implanted pure glass in the goal to highlight its anti-osteoporotic performance. After 60 days, implanted group with 46S6-8RIS showed the increase in bone mineral density (BMD with 10%) and bone volume fraction (BV/TV with 80%) and the decrease in trabecular separation (Tb/Sp with 74%) when compared to that of 46S6 group. These results are confirmed by the histopathological analyses, which showed the bone trabeculae reconnection after the 46S6-8RIS implantation. Chemical analyses showed the reduction in silicon (Si) and sodium (Na) ion concentrations, and the rise in calcium (Ca) and phosphorus (P) ion levels, which was explained by the dissolution of biocomposite matrix and the deposition of hydroxyapatite layer. Histomorphometric results highlighted the risedronate effect on the antiosteoporotic phenomenon. Obtained results showed good behavior with only 8% of introduced risedronate in the glass matrix.
Topics: Animals; Bone Density; Bone Density Conservation Agents; Durapatite; Female; Glass; Magnetic Resonance Spectroscopy; Osteoporosis; Rats; Rats, Wistar; Risedronic Acid
PubMed: 31915685
DOI: 10.1155/2019/2175731 -
Reumatologia Clinica 2015Alendronate and risedronate are both effective and safe treatments for osteoporosis in men, but only risedronate has this indication in its data-sheet. We compared their... (Comparative Study)
Comparative Study
BACKGROUND AND OBJECTIVE
Alendronate and risedronate are both effective and safe treatments for osteoporosis in men, but only risedronate has this indication in its data-sheet. We compared their use by gender.
PATIENT AND METHODS
Retrospective descriptive study of prescriptions of risedronate and alendronate in 2012 in primary care in the northwest area of the Community of Madrid. We compared patients and defined daily doses (DDD) dispensed by gender.
RESULTS
14.857 patients used 1.847.370 DDD of alendronate or risedronate, 1.145 (7.7%) patients were men. In women alendronate was most prescribed (55% vs. 45%) than risedronate. Risedronate was preferred in men, 47.6% vs. 52.4%, resulting in a statistically significant difference (P<.001).
CONCLUSIONS
Risedronate is preferred to alendronate in men, which is often used off-label, despite the existence of alternatives.
Topics: Alendronate; Bone Density Conservation Agents; Drug Administration Schedule; Female; Humans; Male; Off-Label Use; Osteoporosis; Osteoporosis, Postmenopausal; Practice Patterns, Physicians'; Retrospective Studies; Risedronic Acid; Sex Factors; Spain; Treatment Outcome
PubMed: 25107345
DOI: 10.1016/j.reuma.2014.05.003 -
Medicine Mar 2017Low bone mineral density (BMD) is a frequent complication of inflammatory bowel disease (IBD), particularly in patients with Crohn disease (CD). The aim of our study is... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Low bone mineral density (BMD) is a frequent complication of inflammatory bowel disease (IBD), particularly in patients with Crohn disease (CD). The aim of our study is to determine the efficacy and safety of different drugs used to treat low BMD in patients with CD.
METHODS
PUBMED/MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials were searched for eligible studies. A random-effects model within a Bayesian framework was applied to compare treatment effects as standardized mean difference (SMD) with their corresponding 95% credible interval (CrI), while odds ratio (OR) was applied to compare adverse events with 95% CrI. The surface under the cumulative ranking area (SUCRA) was calculated to make the ranking of the treatments for outcomes.
RESULTS
Twelve randomized controlled trials (RCTs) were eligible. Compared with placebo, zoledronate (SMDs 2.74, 95% CrI 1.36-4.11) and sodium-fluoride (SMDs 1.23, 95% CrI 0.19-2.26) revealed statistical significance in increasing lumbar spine BMD (LSBMD). According to SUCRA ranking, zoledronate (SUCRA = 2.5%) might have the highest probability to be the best treatment for increasing LSBMD in CD patients among all agents, followed by sodium-fluoride (27%). For safety assessment, the incidence of adverse events (AEs) demonstrated no statistical difference between agents and placebo. The corresponding SUCRA values indicated that risedronate (SUCRA = 77%) might be the most safe medicine for low BMD in CD patients and alendronate ranked the worst (SUCRA = 16%).
CONCLUSIONS
Zoledronate might have the highest probability to be the best therapeutic strategy for increasing LSBMD. For the safety assessment, risedronate showed the greatest trend to decrease the risk of AEs. In the future, more RCTs with higher qualities are needed to make head-to-head comparison between 2 or more treatments.
Topics: Alendronate; Bayes Theorem; Bone Density; Bone Density Conservation Agents; Bone Diseases, Metabolic; Crohn Disease; Diphosphonates; Humans; Imidazoles; Network Meta-Analysis; Risedronic Acid; Sodium Fluoride; Zoledronic Acid
PubMed: 28296781
DOI: 10.1097/MD.0000000000006378 -
The American Journal of Managed Care Sep 2001Osteoporosis is a prevalent condition among elderly women and is associated with an increased risk for fractures. With the burgeoning size of the elderly population, a... (Review)
Review
Osteoporosis is a prevalent condition among elderly women and is associated with an increased risk for fractures. With the burgeoning size of the elderly population, a practitioner is likely to face many questions regarding the evaluation and management of postmenopausal osteoporosis. This review discusses and compares available therapies. All women should have adequate calcium and vitamin D intake. Women diagnosed as having osteoporosis should be evaluated for secondary causes of osteoporosis and risk factors for falls. For women with postmenopausal osteoporosis, therapy with hormone replacement, bisphosphonates (alendronate sodium or risedronate sodium), raloxifene hydrochloride, or calcitonin should be considered. The results of ongoing studies will help refine the strategies used for management of postmenopausal osteoporosis.
Topics: Aged; Algorithms; Bone Density; Calcitonin; Calcium; Diphosphonates; Estrogens; Female; Fractures, Bone; Humans; Osteoporosis; Postmenopause; Raloxifene Hydrochloride; Risk Factors; Selective Estrogen Receptor Modulators; United States; Women's Health
PubMed: 11599675
DOI: No ID Found -
Iranian Biomedical Journal Mar 2022Inflammatory bone resorption in periodontitis can lead to tooth loss. Systemic administration of bisphosphonates such as risedronate for preventing bone resorption can...
BACKGROUND
Inflammatory bone resorption in periodontitis can lead to tooth loss. Systemic administration of bisphosphonates such as risedronate for preventing bone resorption can cause adverse effects. Alginate hydrogel (ALG) and poly (lactic acid-co-glycolic acid) (PLGA) microparticles have been studied as drug delivery systems for sustained release of drugs. Therefore, the release pattern of risedronate from PLGA microparticles embedded with ALG was studied as a drug delivery system for sustained release of the drug, which can be used in local administrations.
METHODS
Risedronate-containing PLGA microparticles were fabricated using double emulsion solvent evaporation technique. Ionic cross-linking method was used to fabricate risedronate-loaded ALG. Risedronate-containing PLGA microparticles were then coated with ALG. The calibration curve of risedronate was traced to measure encapsulation efficiency (EE) and study the release pattern. Scanning electron microscope (SEM) imaging was carried out, and cell toxicity was examined using MTT assay. Statistical analysis of data was carried out using SPSS ver. 20 software, via one-way ANOVA and Tukey’s tests.
RESULTS
SEM imaging showed open porosities on ALGs. The mean EE of PLGA microparticles for risedronate was 57.14 ± 3.70%. Risedronate released completely after 72 h from ALG, and the cumulative release was significantly higher (p = 0.000) compared to PLGA microspheres coated with ALG, which demonstrated sustained released of risedronate until day 28. Risedronate-loaded ALG showed a significant decrease in gingival fibroblasts cell viability (p < 0.05).
CONCLUSION
Alginate-coated PLGA microspheres could release risedronate in a sustained and controlled way and also did not show cell toxicity. Therefore, they seem to be an appropriate system for risedronate delivery in local applications.
Topics: Alginates; Bone Diseases; Cell Line; Delayed-Action Preparations; Hydrogels; Microspheres; Polylactic Acid-Polyglycolic Acid Copolymer; Risedronic Acid
PubMed: 35090303
DOI: 10.52547/ibj.26.2.124 -
Journal of Bone and Mineral Research :... Nov 2021The determinants of the susceptibility to severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection and severe coronavirus disease 2019 (COVID-19)... (Observational Study)
Observational Study
The determinants of the susceptibility to severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection and severe coronavirus disease 2019 (COVID-19) manifestations are yet not fully understood. Amino-bisphosphonates (N-BPs) have anti-inflammatory properties and have been shown to reduce the incidence of lower respiratory infections, cardiovascular events, and cancer. We conducted a population-based retrospective observational cohort study with the primary objective of determining if oral N-BPs treatment can play a role in the susceptibility to development of severe COVID-19. Administrative International Classification of Diseases, Ninth Revision, Clinical ModificationI (ICD-9-CM) and anatomical-therapeutic chemical (ATC) code data, representative of Italian population (9% sample of the overall population), were analyzed. Oral N-BPs (mainly alendronate and risedronate) were included in the analysis, zoledronic acid was excluded because of the low number of patients at risk. Incidence of COVID-19 hospitalization was 12.32 (95% confidence interval [CI], 9.61-15.04) and 11.55 (95% CI, 8.91-14.20), of intensive care unit (ICU) utilization because of COVID-19 was 1.25 (95% CI, 0.38-2.11) and 1.42 (95% CI, 0.49-2.36), and of all-cause death was 4.06 (95% CI, 2.50-5.61) and 3.96 (95% CI, 2.41-5.51) for oral N-BPs users and nonusers, respectively. Sensitivity analyses that excluded patients with prevalent vertebral or hip fragility fractures and without concomitant glucocorticoid treatment yielded similar results. In conclusion, we found that the incidence of COVID-19 hospitalization, intensive care unit (ICU) utilization, and COVID-19 potentially related mortality were similar in N-BPs-treated and nontreated subjects. Similar results were found in N-BPs versus other anti-osteoporotic drugs. We provide real-life data on the safety of oral N-BPs in terms of severe COVID-19 risk on a population-based cohort. Our results do not support the hypothesis that oral N-BPs can prevent COVID-19 infection and/or severe COVID-19; however, they do not seem to increase the risk. © 2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
Topics: COVID-19; Diphosphonates; Humans; Retrospective Studies; Risedronic Acid; SARS-CoV-2
PubMed: 34405441
DOI: 10.1002/jbmr.4419 -
Scientific Reports Jun 2022The aim of this work was to prepare a biocompatible implant material that enables the release of drug for osteoporosis-risedronate. To achieve this goal, a titanium...
The aim of this work was to prepare a biocompatible implant material that enables the release of drug for osteoporosis-risedronate. To achieve this goal, a titanium implant coated with a biocompatible Zeolitic Imidazolate Framework 8 (ZIF-8) layer was prepared that promotes osseointegration at the bone-implant interface. The modifications of the titanium alloy as well as sorption and desorption processes were confirmed using a variety of methods: SEM, EDS XPS, and FT-IR imaging (to determine surface modification, drug distribution, and risedronate sorption), and UV-Vis spectroscopy (to determine drug sorption and release profile). Both the ZIF-8 layer and the drug are evenly distributed on the surface of the titanium alloy. The obtained ZIF-8 layer did not contain impurities and zinc ions were strongly bounded by ZIF-8 layer. The ZIF-8 layer was stable during drug sorption. The drug was released in small doses for 16 h, which may help patients recover immediately after surgery. This is the first case of using ZIF-8 on the surface of the titanium alloy as carrier that releases the drug under the influence of body fluids directly at the site of the disease. It is an ideal material for implants designed for people suffering from osteoporosis.
Topics: Alloys; Delayed-Action Preparations; Humans; Osteoporosis; Risedronic Acid; Spectroscopy, Fourier Transform Infrared; Titanium; Zeolites
PubMed: 35650310
DOI: 10.1038/s41598-022-13187-0