Recommendations for the clinical evaluation of agents for treatment of osteoporosis: Consensus of an expert panel representing the American Society for Bone and Mineral Research (ASBMR), the International Society for Clinical Densitometry (ISCD), and the National Osteoporosis Foundation (NOF)

Journal of Bone and Mineral Research

Volumn 23, Issue 1, 2008, Pages 159-165

  Silverman, Stuart L ^a   Cummings, Steven R ^b   Watts, Nelson B ^c  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

Author keywords

Evaluation; Osteoporosis treatment

Indexed keywords

BISPHOSPHONIC ACID DERIVATIVE; CORTICOSTEROID; PLACEBO; SELECTIVE ESTROGEN RECEPTOR MODULATOR;

ARTICLE; BONE DENSITY; BONE TURNOVER; CONSENSUS DEVELOPMENT; CORTICOSTEROID INDUCED OSTEOPOROSIS; EVIDENCE BASED MEDICINE; FRAGILITY FRACTURE; HUMAN; MEDICAL SOCIETY; OSTEOPOROSIS; PRACTICE GUIDELINE; TREATMENT INDICATION;

BONE DENSITY CONSERVATION AGENTS; CLINICAL TRIALS AS TOPIC; DRUG EVALUATION; FRACTURES, BONE; HUMANS; INFORMED CONSENT; OSTEOPOROSIS; PLACEBOS; RISK; SOCIETIES, MEDICAL;

EID: 37549063366     PISSN: 08840431     EISSN: None     Source Type: Journal    
DOI: 10.1359/jbmr.070905     Document Type: Article

References (3)

1. Food and Drug Administration 2004 Draft guidance for industry on the preclinical and clinical evaluation of agents used in the prevention or treatment of postmenopausal osteoporosis: Request for comments. Fed Regist 69:6673-6675.
2. Park RE, Fink A, Brook RH, Chassin MR, Kahn KL, Marrick NJ, Kosecoff S, Solomon DH 1999 Physician ratings of appropriate indications for three procedures: Theoretical indications vs indications used in practice. Am J Public Health 79:445-447.
3. European Medicines Agency 2005 Guideline on the Evaluation of New Medicinal Products in the Treatment of Osteoporosis. Available at www.emea.eu.int/pdfs/human/ewp/055295en.pdf. Accessed October 24, 2007.