Clodronate is a medicine used to treat a high level of calcium in the blood caused by changes in the body that happen with cancer. Weekly paracetamol consumption was categorized by the proportion of patients who did not require its use. Clodronate has been also encapsulated in liposomes in order to increase its cellular uptake [28].
Your doctor may give you a smaller amount of clodronate to take.
Unfortunately, the development of this formulation was discontinued, but with the IA doses we used, the amount of clodronate absorbed by knee articular cartilage in our patients is likely to be considerably higher than that possibly achieved with extremely large doses of oral clodronate. 2). This is a multicentre, randomized, partially double blind Phase 2 study, aimed at identifying the most appropriate dose of IA clodronate, for relieving pain and improving function of an osteoarthritic knee over 5 weeks. History and functional mechanisms, Clodronate inhibits the secretion of proinflammatory cytokines and NO by isolated microglial cells and reduces the number of proliferating glial cells in excitotoxically injured organotypic hippocampa slice cultures, The Author 2009. All rights reserved. Viscosupplementation for the treatment of osteoarthritis of the knee. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Other side effects not listed may also occur in some patients. 1998-2022 Mayo Foundation for Medical Education and Research (MFMER). The burning was statistically more frequent in the clodronate 2 mg group as compared with the other groups given < 2 mg clodronate/week (chi-square test, P < 0.05). This information is only for vets. There were no significant differences among treatment groups (ANOVA or chi-square test).
Agents that suppress bone turnover, including bisphosphonates, have been associated with fewer subchondral bony lesions, as visualized by MRI, in patients with OA [15]. The following information includes only the average doses of this medicine. This medicine is available only with your doctor's prescription. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Clodronic acid is approved for human use in Canada and Australia, the United Kingdom, where it is marketed as Bonefos, Loron, Clodron and in Italy as Clasteon, Difosfonal, Osteostab and several generics. It is not approved for use in the United States, because it has too many adverse effects. ); Rheumatology Unit, University of Padua (Silvano Todesco). The trial was conducted in accordance with the ethics principles of the Declaration of Helsinki and was approved by the local research ethics committees. However, in a large ad hoc randomized clinical trial, doses of oral risedronate 2- to 3-fold higher than those commonly used for the treatment of post-menopausal osteoporosis failed to prevent the progression of KOA [19]. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. By using our website, you agree to our Copyright 2022 British Society for Rheumatology. You may report side effects to the FDA at 1-800-FDA-1088. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. Percent changes in the AUC for each VAS and for each treatment group. None of the among-treatment differences were statistically significant. Many medicines have not been studied specifically in older people. Validationvalue in comparison with other assessment tests, On closed test procedures for dose-response analysis. An alternative approach might be represented by the administration of IA clodronate, a bisphosphonate with anti-inflammatory effects in experimental arthritis [27]. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Joint mobility scores were categorized as improved, unchanged or worsened, in comparison with the baseline. Objective. of 18 mm. Dechra is an international veterinary pharmaceuticals and related products business. Maresin 1 intervention Reverses Experimental Pulmonary Arterial Hypertension in mice. has received honoraria and/or consulting fees from Abbott, Amgen, Eli Lilly, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Schering-Plough, Servier and Wyeth. Along with its needed effects, a medicine may cause some unwanted effects. Paracetamol consumption (counting the returned pills that were provided weekly by the investigators). Please check for further notifications by email. NSAIDs should not be used concurrently with OSPHOS. Along with its needed effects, a medicine may cause some unwanted effects. There is no specific information comparing use of clodronate in the elderly with use in other age groups. Characteristics and Outcomes of a Hispanic Lupus Nephritis Cohort from Mexico, Examination of nailfold videocapillaroscopy findings in ANCA-associated vasculitis, Serum cholesterol loading capacity on macrophages is regulated by seropositivity and C-reactive protein in rheumatoid arthritis patients, Basic calcium phosphate crystals induce the expression of extracellular matrix remodelling enzymes in tenocytes, Influence of HLA polymorphisms on clinical features of VEXAS syndrome: a potential epistatic mechanism, About the British Society for Rheumatology, British Society for Rheumatology Journals, https://doi.org/10.1093/rheumatology/kep084, Receive exclusive offers and updates from Oxford Academic, Improved prediction of knee osteoarthritis progression by genetic polymorphisms: the Arthrotest Study, A 2 yr longitudinal radiographic study examining the effect of a bisphosphonate (risedronate) upon subchondral bone loss in osteoarthritic knee patients, Predictors of response to intra-articular steroid injections in knee osteoarthritisa systematic review, Measurement properties of the osteoarthritis of knee and hip quality of life OAKHQOL questionnaire: an item response theory analysis. None of the among-treatment differences was statistically significant. In other countries is prescribed as a bone resorption inhibitor and antihypercalcemic agent. The percent changes in AUC for each VAS and for the average of the four VASs are shown in Fig. Find our useful supplementary materials, free eLearning courses and the latest articles on our therapy areas: By clicking a flag you will be leaving this country website to access another site in the Dechra group not applicable to your territory and which may have different legislation. Follow your doctor's orders or the directions on the label. Call your doctor for medical advice about side effects. This is a decision you and your doctor will make. OSPHOS should not be used in pregnant or lactating mares, or mares intended for breeding. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. It is very important that you take adequate fluid before and while taking clodronate. For Permissions, please email: journals.permissions@oxfordjournals.org. Methods. In this study, we compare the symptomatic and functional changes occurring in patients with severe KOA of IA HA or clodronate at three different doses in a partially blind, randomized clinical trial.
The recruited patients were asked to discontinue any NSAIDs at least 4 days before the first injection. Six Italian centres participated in the trial.
Stomach cramping or pain, nausea, stomach burningTaking clodronate, especially by mouth, may make your stomach problems worse, Kidney problemsTaking clodronate may cause your kidney problems to get worse. A significant (P = 0.03) linear trend for a doseresponse (0.52 mg clodronate) relationship was found for active movement VAS pain. All other authors have declared no conflicts of interest. The amount of medicine may be less if you have kidney problems. Thus, the only efficient way to test the efficacy of clodronate in OA remains the direct IA administration of relatively high doses of clodronate. When data were adjusted for paracetamol use, the spontaneous pain was significantly different among groups (ANCOVA, P = 0.05) with a highly significant difference (P < 0.01) between clodronate 1 + 1 mg and HA group. Check with your doctor immediately if any of the following side effects occur: Some side effects may occur that usually do not need medical attention. Pain continued to improve thereafter, 2 (clodronate 0.5, 1 and 2 mg or HA) and 4 (clodronate 1 + 1 mg) weeks after the last injection (Fig. Recent reviews, guidelines and meta-analysis consistently attribute an appreciable therapeutic effect to HA [5, 6, 35, 36]. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 1).
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. The continuous variables [VAS and Lequesne index changes, percent changes in the AUC (AUC, elapsed time changes in score value) for the four VASs] were compared by analysis of covariance (ANCOVA) and then t-test after adjustment for paracetamol consumption (number of weekly tablets), using Bonferroni correction. ); Division of Rheumatology, Ospedale di Potenza (I.O. The lack of a clear doseresponse relationship might be due to the shadowing placebo effect, but it is also possible that the lowest dose we adopted is already close to the upper part of the doseresponse curve. These conflicting results may be explained by the pharmaco-dynamic properties of bisphosphonates. Clodronic acid is also used in experimental medicine to selectively deplete macrophages. This positive view is also somewhat supported by the trend of better results observed with clodronate 2 mg and 1 + 1 mg vs HA treatment in percent AUC changes for VAS for spontaneous and active movement pain. ChildrenUse and dosage must be determined by your doctor. Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali - Agenzia Italiana del Farmaco. This is the reason for which HA treatment was not blind to the investigator in this study. Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of clodronate in children with use in other age groups. Joint mobility as assessed by the investigator on an arbitrary scale from 1 (complete) to 4 (totally compromised). Both joint extension and mobility scores improved significantly at all time points in all treatment groups without statistical differences among them. However, local burning after the injection, lasting 12 min, was reported by 21% of the patients given 2 mg clodronate, and this proportion was statistically (chi square) higher than that reported in the patients given clodronate 0.5 mg and HA injections (Table 3). All reported results are by ITT analysis, whereby the missing values were all substituted throughout with the last available value. If both knees met the inclusion criteria, only the more symptomatic was treated.
Call 911 for all medical emergencies. It is given by intramuscular injection at one point in time, with the total dose divided into 2-3 sites on the horse.
Funding: The clinical trial was fully funded by Abiogen S.p.A., Pisa, Italy.
NEW The Essential Diabetes Book - Mayo Clinic Press, Mayo Clinic on Incontinence - Mayo Clinic Press, NEW Mayo Clinic on Hearing and Balance - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. Keep from freezing. An interesting alternative approach tested in the past was represented by the use of clodronate-containing liposomes, which gives very high concentrations of the drug in the cells, with enhanced anti-inflammatory activity, particularly when given intra-articularly [28, 29]. The linear trend for the clodronate doseresponse relationship is statistically significant for mobility score (P = 0.03).
Clodronate also treats the weakening in the bones when cancer has spread to the bones from another part of the body. Results.
If you notice any other effects, check with your healthcare professional. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Mayo Clinic does not endorse companies or products. The IA injection was considered painful by only a few patients. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The safe use of OSPHOS has not been evaluated in horses less than 4 years of age or breeding horses. Patients were randomly allocated to receive one of the following treatments: Studies in women breastfeeding have demonstrated harmful infant effects. ); Rheumatology Unit, Ospedale di Arenzano (G.B. No significant difference in any of the VAS scores was detected among the five treatment groups at any time point. This site complies with the HONcode standard for trustworthy health information: verify here.
Symptoms and functions with all treatments were still improving at the last time point and this might suggest a therapeutic effect extending over several weeks after the treatment course. Physical multimorbidity and wish to die among adults aged 65years: A cross-sectional analysis of the Irish Longitudinal Study on Ageing. Thank you for submitting a comment on this article. Bisphosphonates may have a chondroprotective effect in patients with knee OA (KOA), but the results of clinical trials with oral bisphosphonates have been contradictory.
Extension score as assessed by a 1 (complete) to 4 (totally compromised) scale. Flow diagram of patients progress through the design of the study. Use of OSPHOS in patients with conditions affecting renal function or mineral or electrolyte homeostasis is not recommended. Your comment will be reviewed and published at the journal's discretion. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine. By using our website, you agree to our, This website uses cookies to improve your experience. Written informed consent was obtained from each patient. Trial Registration. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education, Clodronic Acid (Oral Route, Injection Route), muscle cramps in hands, arms, feet, legs, or face. The extension and mobility scores improved significantly at all time points in all treatment groups without statistical differences (chi square) among groups, even though a trend for better results was observed for clodronate 1 + 1 mg vs the other treatments (P-values ranging from 0.06 to 0.34; Fig. Clodronic acid has been shown to have several adverse effects. Hylan versus hyaluronic acid for osteoarthritis of the knee: a systematic review and meta-analysis, Efficacy and safety of intraarticular hylan or hyaluronic acids for osteoarthritis of the knee. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials, EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT), OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines, Introduction to bisphosphonates.
To what extent these results might be related to the well-recognized placebo response after aspiration of the knee [33, 34] remains unclear. The proportion of patients who did not require the use of paracetamol and the number of tablets taken during the observational period did not significantly differ [analysis of variance (ANOVA)] among treatment groups (Table 2), even though the individual values were occasionally considerably different.
For non-prescription products, read the label or package ingredients carefully. 3. This content does not have an Arabic version. Whenever the linear trend analysis for a doseresponse relationship was found statistically significant, this was again tested for the step-down (exclusion of the less effective) and fixed-sequence (from lowest to highest dose) of the Dunnett test [32]. When the changes in walking pain and in spontaneous pain were adjusted by global paracetamol use, the treatment differences were statistically significant (ANCOVA, P = 0.05) with a highly significant difference (*P < 0.01) between clodronate 1 + 1 mg and HA. However, the condition is often associated with pain and functional disability, for which analgesic agents and NSAIDs, including cyclo-oxygenase 2 inhibitors (COXIBs), are the most widely prescribed medications. Portions of this document last updated: Feb. 01, 2022. The 150 eligible patients were recruited over 18 months until September 2005. We are grateful to Dr Marco Bulleri and Dr Fabrizio Nannipieri (Abiogen Pharma S.p.A., Pisa, Italy) for their contribution on data monitoring and statistical analysis.
This website uses cookies to improve your experience. The following centres participated in the clinical trials: Rheumatology Unit, University of Siena (Roberto Marcolongo); Rheumatology Unit, University of Verona (S.A.); Rheumatology Unit, Ospedale Sacco, Milan (Mario Carabba); Rheumatology Unit, University of Bari (G.L. Clodronic acid is approved for use in horses under the trade name Osphos, for treatment of bone resorptive processes of navicular syndrome. At the ANOVA test, none of the percent changes in AUC differed significantly among groups, after Bonferroni adjustment for multiple comparisons. Patients were randomized in blocks of five by a computer program. 
The clodronate-containing liposomes when administered IA lead to macrophage depletion and decreased expression of adhesion molecules in the synovial lining in patients with RA [29].
The uncertainties still persisting on the real therapeutic value of HA also leave the interpretation of the results reported here with IA clodronate open. One hundred and forty-five patients received at least one IA injection and represent the study population included in the ITT analysis. One uncontrolled study of etidronate demonstrated an improvement in subjective pain in individuals with spondylosis and KOA [16], and in a recent secondary analysis of data from a randomized controlled trial [fracture intervention trial (FIT)], alendronate was associated with less spinal osteophytes and disc-space narrowing progression than placebo [17]. In conclusion, our study demonstrates that IA clodronate provides symptomatic and functional improvements at least as good as those obtained with HA. Although not all of these side effects may occur, if they do occur they may need medical attention. The sponsor and each individual author agreed with the contents of the manuscript and gave their agreement to submit the manuscript for publication.
Links to other sites are provided for information only -- they do not constitute endorsements of those other sites. Call your doctor for medical advice about side effects. For treating hypercalcemia (too much calcium in the blood): Adults1600 milligrams (mg) to 2400 mg given in one or two divided amounts per day. In field studies and post-approval experience the most common side effects reported were signs of discomfort, nervousness, and colic.
Although not all of these side effects may occur, if they do occur they may need medical attention. The five treatment groups had similar clinical characteristics at baseline (Table 1). IA HA is generally considered as a valuable addition to the therapeutic armamentarium for the treatment of OA. Equidone Gel (domperidone) (domperidone). In this Phase 2 randomized, partially blind clinical trial, we tested the efficacy of IA clodronate vs HA in patients with primary KOA. Baseline characteristics of the study population. improvement of lameness) after a single treatment can be seen up to 6 months post-treatment.
The amount of medicine that you take depends on the strength of the medicine. On the day of treatment and at weekly intervals for 5 weeks, the following data were collected: VAS (0100 mm) to assess all types of pain: spontaneous, on passive and active movement (walking for >10 m), and at digital pressing of the two lateral articular spaces (tenderness). The issue of the potential placebo effect is also obviously critical to attribute a therapeutic effect to clodronate. Clinical effects (e.g.
You should take clodronate at least two hours before or after food. OA is a major cause of musculoskeletal pain, disability and handicap, and an important community health care burden. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. It is an anti-osteoporotic drug approved for the prevention and treatment of osteoporosis in post-menopausal women and men to reduce vertebral fractures, hyperparathyroidism, hypercalcemia in malignancy, multiple myeloma and fracture related pain because of its potent anti-inflammatory and analgesic effects shown as a reduction in inflammatory markers like IL-1, IL-6, and TNF-.[1].
OSPHOS is an injectable bisphosphonate solution for the control of clinical signs associated with navicular syndrome in horses four years and older.
This website uses cookies to provide necessary site functionality and improve your experience. As with all drugs, side effects may occur. These position papers made and are still making a placebo arm for IA injections ethically unacceptable, despite the clinically minimal effect of HA as compared to placebo. One hundred and fifty men or women aged 5075 years suffering from KOA were randomized to one of five IA therapies: (i) clodronate 0.5 mg one IA injection/week for 4 weeks; (ii) clodronate 1 mg one IA injection/week for 4 weeks; (iii) clodronate 2 mg one IA injection/week for 4 weeks; (iv) clodronate 1 mg two IA injections/week for 2 weeks (clodronate 1 + 1 mg); and (v) HA 20 mg one IA injection/week for 4 weeks.
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