Recommendations for the Registration of Agents to be Used in the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis: Updated Recommendations from the Group for the Respect of Ethics and Excellence in Science
The Group for the Respect and Excellence in Science (GREES) has reviewed and updated their recommendations for clinical trials to evaluate the efficacy and safety of new chemical entities to be used in the treatment and prevention of glucocorticoid-induced osteoporosis (GIOP). Consensus discussion o...
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Published in | Seminars in arthritis and rheumatism Vol. 35; no. 1; pp. 1 - 4 |
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Main Authors | , , , , , , , , , , , , , , , , , , |
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Language | English |
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01.08.2005
W.B. Saunders |
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Abstract | The Group for the Respect and Excellence in Science (GREES) has reviewed and updated their recommendations for clinical trials to evaluate the efficacy and safety of new chemical entities to be used in the treatment and prevention of glucocorticoid-induced osteoporosis (GIOP).
Consensus discussion of the committee.
With the exception of steroid use posttransplantation, there is no need to differentiate between underlying diseases. Prevention and treatment for GIOP are dependent on exposure to glucocorticoids rather than T-scores as in postmenopausal osteoporosis (PMO). If fracture data are obtained for PMO, it need not be repeated for GIOP, relying instead on bone mineral density (BMD) trials of at least 1 year. GREES recommends several changes in the previous guidance for GIOP. The committee saw no need to repeat preclinical studies if those have been previously done to assure bone quality in PMO. Similarly, phase I and phase II trials, if careful dose selection has been done for PMO, should not be repeated. The “prevention” and “treatment” claims should remain. Since the most recent evidence suggests significant increase in fracture risk for daily doses of prednisone of 5 mg/day or equivalent, clinical trials should concentrate on patients receiving at least this daily dosage. The emergence of bisphosphonates as the reference treatment, together with the rapid bone loss and high fracture incidence in glucocorticoid users, necessitates recommending a noninferiority trial design with lumbar spine BMD as the primary endpoint after 1 year.
Registration of new chemical entities to be used in the management of GIOP should be granted, based on a 1-year noninferiority trial, using BMD as primary outcome and alendronate or risedronate as comparator. Demonstration of antifracture efficacy should have been previously demonstrated in PMO. |
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AbstractList | OBJECTIVES: The Group for the Respect and Excellence in Science (GREES) has reviewed and updated their recommendations for clinical trials to evaluate the efficacy and safety of new chemical entities to be used in the treatment and prevention of glucocorticoid-induced osteoporosis (GIOP). METHODS: Consensus discussion of the committee. RESULTS: With the exception of steroid use posttransplantation, there is no need to differentiate between underlying diseases. Prevention and treatment for GIOP are dependent on exposure to glucocorticoids rather than T-scores as in postmenopausal osteoporosis (PMO). If fracture data are obtained for PMO, it need not be repeated for GIOP, relying instead on bone mineral density (BMD) trials of at least 1 year. GREES recommends several changes in the previous guidance for GIOP. The committee saw no need to repeat preclinical studies if those have been previously done to assure bone quality in PMO. Similarly, phase I and phase II trials, if careful dose selection has been done for PMO, should not be repeated. The "prevention" and "treatment" claims should remain. Since the most recent evidence suggests significant increase in fracture risk for daily doses of prednisone of 5 mg/day or equivalent, clinical trials should concentrate on patients receiving at least this daily dosage. The emergence of bisphosphonates as the reference treatment, together with the rapid bone loss and high fracture incidence in glucocorticoid users, necessitates recommending a noninferiority trial design with lumbar spine BMD as the primary endpoint after 1 year. CONCLUSIONS: Registration of new chemical entities to be used in the management of GIOP should be granted, based on a 1-year noninferiority trial, using BMD as primary outcome and alendronate or risedronate as comparator. Demonstration of antifracture efficacy should have been previously demonstrated in PMO. The Group for the Respect and Excellence in Science (GREES) has reviewed and updated their recommendations for clinical trials to evaluate the efficacy and safety of new chemical entities to be used in the treatment and prevention of glucocorticoid-induced osteoporosis (GIOP). Consensus discussion of the committee. With the exception of steroid use posttransplantation, there is no need to differentiate between underlying diseases. Prevention and treatment for GIOP are dependent on exposure to glucocorticoids rather than T-scores as in postmenopausal osteoporosis (PMO). If fracture data are obtained for PMO, it need not be repeated for GIOP, relying instead on bone mineral density (BMD) trials of at least 1 year. GREES recommends several changes in the previous guidance for GIOP. The committee saw no need to repeat preclinical studies if those have been previously done to assure bone quality in PMO. Similarly, phase I and phase II trials, if careful dose selection has been done for PMO, should not be repeated. The “prevention” and “treatment” claims should remain. Since the most recent evidence suggests significant increase in fracture risk for daily doses of prednisone of 5 mg/day or equivalent, clinical trials should concentrate on patients receiving at least this daily dosage. The emergence of bisphosphonates as the reference treatment, together with the rapid bone loss and high fracture incidence in glucocorticoid users, necessitates recommending a noninferiority trial design with lumbar spine BMD as the primary endpoint after 1 year. Registration of new chemical entities to be used in the management of GIOP should be granted, based on a 1-year noninferiority trial, using BMD as primary outcome and alendronate or risedronate as comparator. Demonstration of antifracture efficacy should have been previously demonstrated in PMO. |
Author | Delmas, Pierre D. Kreutz, Gottfried Ethgen, Dominique J. Mitlak, Bruce H. Menkes, Charles J. Laslop, Andrea Dere, Willard H. Orloff, John J. Ringe, Johann D. Branco, Jaime Tsouderos, Yannis Abadie, Eric C. Vanhaelst, Luc Reginster, Jean-Yves L. Vanderauwera, Philippe M. Avouac, Bernard P. Bouvenot, Gilles M. Altman, Roy D. Devogealer, Jean-Pierre |
Author_xml | – sequence: 1 givenname: Eric C. surname: Abadie fullname: Abadie, Eric C. organization: Department of Public Health, Epidemiology, and Health Economics, University of Liège, Liège, Belgium – sequence: 2 givenname: Jean-Pierre surname: Devogealer fullname: Devogealer, Jean-Pierre organization: Rheumatology Unit, St-Luc University Hospital, Université Catholique de Louvain, Louvain, Belgium – sequence: 3 givenname: Johann D. surname: Ringe fullname: Ringe, Johann D. organization: Klinikum Leverkusen, Leverkusen, Germany – sequence: 4 givenname: Dominique J. surname: Ethgen fullname: Ethgen, Dominique J. organization: GlaxoSmithKline, Collegeville, PA, USA – sequence: 5 givenname: Gilles M. surname: Bouvenot fullname: Bouvenot, Gilles M. organization: Department of Clinical Trials Methodology, Faculté de Médecine, Marseille Cedex 5, France – sequence: 6 givenname: Gottfried surname: Kreutz fullname: Kreutz, Gottfried organization: BfArM, ARM, Bonn, Germany – sequence: 7 givenname: Andrea surname: Laslop fullname: Laslop, Andrea organization: Department of Pharmacology, University of Innsbruck, Innsbruck, Austria – sequence: 8 givenname: John J. surname: Orloff fullname: Orloff, John J. organization: Novartis Pharma, East Hanover, NJ, USA – sequence: 9 givenname: Philippe M. surname: Vanderauwera fullname: Vanderauwera, Philippe M. organization: F. Hoffmann-La Roche, Basle, Switzerland – sequence: 10 givenname: Pierre D. surname: Delmas fullname: Delmas, Pierre D. organization: Claude Bernard University and INSERM Research Unit 403, Lyon, France – sequence: 11 givenname: Willard H. surname: Dere fullname: Dere, Willard H. organization: Amgen, Inc., Thousand Oaks, CA, USA – sequence: 12 givenname: Jaime surname: Branco fullname: Branco, Jaime organization: BfArM, ARM, Bonn, Germany – sequence: 13 givenname: Roy D. surname: Altman fullname: Altman, Roy D. organization: Rheumatology and Immunology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA – sequence: 14 givenname: Bernard P. surname: Avouac fullname: Avouac, Bernard P. organization: Novartis Pharma, East Hanover, NJ, USA – sequence: 15 givenname: Charles J. surname: Menkes fullname: Menkes, Charles J. organization: F. Hoffmann-La Roche, Basle, Switzerland – sequence: 16 givenname: Luc surname: Vanhaelst fullname: Vanhaelst, Luc organization: Claude Bernard University and INSERM Research Unit 403, Lyon, France – sequence: 17 givenname: Bruce H. surname: Mitlak fullname: Mitlak, Bruce H. organization: Eli Lilly & Company, Indianapolis, IN, USA – sequence: 18 givenname: Yannis surname: Tsouderos fullname: Tsouderos, Yannis organization: Institut de Recherche Internationale Servier, Paris, France – sequence: 19 givenname: Jean-Yves L. surname: Reginster fullname: Reginster, Jean-Yves L. email: jyreginster@ulg.ac.be organization: World Health Organization Collaborating Center for Public Health Aspects of Rheumatic Diseases, Department of Public Health, Epidemiology, and Health Economics, University of Liege, Liege, Belgium |
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Snippet | The Group for the Respect and Excellence in Science (GREES) has reviewed and updated their recommendations for clinical trials to evaluate the efficacy and... OBJECTIVES: The Group for the Respect and Excellence in Science (GREES) has reviewed and updated their recommendations for clinical trials to evaluate the... |
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SubjectTerms | clinical trial Clinical Trials as Topic General & internal medicine glucocorticoid Glucocorticoids - adverse effects guidelines Health Planning Guidelines Human health sciences Humans Médecine générale & interne osteoporosis Osteoporosis - chemically induced Osteoporosis - drug therapy Osteoporosis - prevention & control Osteoporosis/chemically induced/drug therapy/prevention & control Rheumatic Diseases - drug therapy Sciences de la santé humaine steroid |
Title | Recommendations for the Registration of Agents to be Used in the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis: Updated Recommendations from the Group for the Respect of Ethics and Excellence in Science |
URI | https://dx.doi.org/10.1016/j.semarthrit.2005.03.006 https://www.ncbi.nlm.nih.gov/pubmed/16084217 http://orbi.ulg.ac.be/handle/2268/25339 |
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