The use of placebo-controlled and non-inferiority trials for the evaluation of new drugs in the treatment of postmenopausal osteoporosis

Osteoporosis International

Volumn 13, Issue 1, 2002, Pages 1-5

  Delmas, P D ^a   Calvo, G ^b   Boers, M ^c   Abadie, E ^d   Avouac, B ^e   Kahan, A ^f   Kaufman, J M ^g   Laslop, A ^h   Lekkerkerker, J F ⁱ   Nilsson, P ^j   Van Zwieten Boot, B ⁱ   Kreutz, G ^k   Reginster, J Y ^l  

^a UNIVERSITÉ LYON 1   (France)

^b UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^c VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^d Agence du medicament   (France)

^e HENRI MONDOR HOSPITAL   (France)

^f UNIVERSITÉ PARIS DESCARTES   (France)

^g GHENT UNIVERSITY HOSPITAL   (Belgium)

^h INNSBRUCK MEDICAL UNIVERSITY   (Austria)

ⁱ MEDICINES EVALUATION BOARD   (Netherlands)

^j Medical Product Agency   (Sweden)

^k BfArM   (Germany)

^l WORLD HEALTH ORGANIZATION   (Switzerland)

more..

Author keywords

Clinical trial; Drug registration; Osteoporosis; Placebo

Indexed keywords

ALENDRONIC ACID; CALCIUM; NEW DRUG; PARATHYROID HORMONE[1-34]; PLACEBO; RALOXIFENE; RISEDRONIC ACID; VITAMIN D;

CLINICAL TRIAL; DRUG EFFICACY; DRUG LEGISLATION; DRUG SCREENING; EUROPEAN UNION; FEASIBILITY STUDY; HEALTH CARE AVAILABILITY; HEALTH CARE DELIVERY; HIP FRACTURE; HUMAN; INTERMETHOD COMPARISON; MEDICAL ETHICS; MEDICAL RESEARCH; METHODOLOGY; POSTMENOPAUSE OSTEOPOROSIS; PRIORITY JOURNAL; REVIEW; TREATMENT OUTCOME; VERTEBRA FRACTURE;

EID: 18244385014     PISSN: 0937941X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s198-002-8331-3     Document Type: Review

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