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Recommendations for an update of the current (2001) regulatory requirements for registration of drugs to be used in the treatment of osteoporosis in postmenopausal women and in men

Reginster, JY ; Abadie, E ; Delmas, P ; Rizzoli, R ; Dere, W ; der Auwera, P ; Avouac, B ; Brandi, ML ; Daifotis, A and Diez-Perez, A , et al. (2006) In Osteoporosis International 17(1). p.41281-41281
Abstract
Recent advances in the understanding of the epidemiology of osteoporosis suggest that certain parts of the current European guidelines for the registration of drugs in osteoporosis might be no longer substantiated. The object of this review is to provide the European regulatory authorities with an evidence-based working document providing suggestions for the revision of the "Note for guidance for the approval of drugs to be used in postmenopausal osteoporosis" (CPMP/EWP/552/95). Following an extensive review of the literature (1990-2004), the Group for the Respect of Ethics and Excellence in Science (GREES) organized a workshop including European regulators, academic scientists and representatives of the pharmaceutical industry. The... (More)
Recent advances in the understanding of the epidemiology of osteoporosis suggest that certain parts of the current European guidelines for the registration of drugs in osteoporosis might be no longer substantiated. The object of this review is to provide the European regulatory authorities with an evidence-based working document providing suggestions for the revision of the "Note for guidance for the approval of drugs to be used in postmenopausal osteoporosis" (CPMP/EWP/552/95). Following an extensive review of the literature (1990-2004), the Group for the Respect of Ethics and Excellence in Science (GREES) organized a workshop including European regulators, academic scientists and representatives of the pharmaceutical industry. The outcomes of this meeting reflect the personal views of those who attended and should not, in any case, be seen as an official position paper of any regulatory agency. The group identified a certain number of points that deserve discussion. They mainly relate to the nature of the indication being granted to new chemical entities (treatment of osteoporosis in women at high risk of fracture instead of prevention and treatment of osteoporosis), the requirements of showing an anti-fracture efficacy on all or on major nonvertebral fractures (instead of the hip), the duration of pivotal trials (2 years instead of 3) and the possibility of considering bridging studies for new routes of administration, new doses or new regimens of previously approved drugs. The group also recommends that an indication could be granted for the treatment of osteoporosis in males on the basis of a placebo-controlled study, with bone mineral density changes after 1 year as the primary endpoint, for medications approved in the treatment of osteoporosis in women at high risk of fractures. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
registration of drugs, osteoporosis, postmenopausal
in
Osteoporosis International
volume
17
issue
1
pages
41281 - 41281
publisher
Springer
external identifiers
  • wos:000233997900001
  • scopus:29144508420
  • pmid:16091835
ISSN
1433-2965
DOI
10.1007/s00198-005-1984-3
language
English
LU publication?
yes
id
e3e9f8e5-b810-44ee-94e2-94f4cf57007f (old id 693776)
date added to LUP
2016-04-01 17:15:57
date last changed
2021-02-17 06:55:47
@misc{e3e9f8e5-b810-44ee-94e2-94f4cf57007f,
  abstract     = {Recent advances in the understanding of the epidemiology of osteoporosis suggest that certain parts of the current European guidelines for the registration of drugs in osteoporosis might be no longer substantiated. The object of this review is to provide the European regulatory authorities with an evidence-based working document providing suggestions for the revision of the "Note for guidance for the approval of drugs to be used in postmenopausal osteoporosis" (CPMP/EWP/552/95). Following an extensive review of the literature (1990-2004), the Group for the Respect of Ethics and Excellence in Science (GREES) organized a workshop including European regulators, academic scientists and representatives of the pharmaceutical industry. The outcomes of this meeting reflect the personal views of those who attended and should not, in any case, be seen as an official position paper of any regulatory agency. The group identified a certain number of points that deserve discussion. They mainly relate to the nature of the indication being granted to new chemical entities (treatment of osteoporosis in women at high risk of fracture instead of prevention and treatment of osteoporosis), the requirements of showing an anti-fracture efficacy on all or on major nonvertebral fractures (instead of the hip), the duration of pivotal trials (2 years instead of 3) and the possibility of considering bridging studies for new routes of administration, new doses or new regimens of previously approved drugs. The group also recommends that an indication could be granted for the treatment of osteoporosis in males on the basis of a placebo-controlled study, with bone mineral density changes after 1 year as the primary endpoint, for medications approved in the treatment of osteoporosis in women at high risk of fractures.},
  author       = {Reginster, JY and Abadie, E and Delmas, P and Rizzoli, R and Dere, W and der Auwera, P and Avouac, B and Brandi, ML and Daifotis, A and Diez-Perez, A and Calvo, G and Johnell, Olof and Kaufman, JM and Kreutz, G and Laslop, A and Lekkerkerker, F and Mitlak, B and Nilsson, P and Orloff, J and Smillie, M and Taylor, A and Tsouderos, Y and Ethgen, D and Flamion, B},
  issn         = {1433-2965},
  language     = {eng},
  number       = {1},
  pages        = {41281--41281},
  publisher    = {Springer},
  series       = {Osteoporosis International},
  title        = {Recommendations for an update of the current (2001) regulatory requirements for registration of drugs to be used in the treatment of osteoporosis in postmenopausal women and in men},
  url          = {http://dx.doi.org/10.1007/s00198-005-1984-3},
  doi          = {10.1007/s00198-005-1984-3},
  volume       = {17},
  year         = {2006},
}