Is It Ethical to Conduct Placebo-Controlled Clinical Trials in the Development of New Agents for Osteoporosis? An Industry Perspective

Journal of Bone and Mineral Research

Volumn 18, Issue 6, 2003, Pages 1142-1145

  Rosenblatt, Michael ^a,b  

^a HARVARD MEDICAL SCHOOL   (United States)

^b HARVARD INSTITUTES OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ETIDRONIC ACID; FLUORIDE; PLACEBO;

BONE DENSITY; BONE MASS; BONE MINERAL; CLINICAL RESEARCH; CLINICAL TRIAL; CONFERENCE PAPER; DRUG APPROVAL; DRUG EFFICACY; DRUG INDICATION; DRUG INDUSTRY; DRUG RESEARCH; HUMAN; MEDICAL ETHICS; OSTEOPOROSIS; OUTCOMES RESEARCH; TREATMENT INDICATION;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

CONTROLLED CLINICAL TRIALS; ETHICS, MEDICAL; INDUSTRY; OSTEOPOROSIS; PLACEBOS; RANDOMIZED CONTROLLED TRIALS; REPRODUCIBILITY OF RESULTS; RISK ASSESSMENT; UNITED STATES;

EID: 0142122885     PISSN: 08840431     EISSN: None     Source Type: Journal    
DOI: 10.1359/jbmr.2003.18.6.1142     Document Type: Conference Paper

References (5)

1. Black DM, Thompson DE, Bauer DC, Ensrud K, Musliner T, Hochberg MC, Nevitt MC, Suryawanshi S, Cummings SR for the FIT Research Group 2000 Fracture risk reduction with alendronate in women with osteoporosis: The fracture intervention trial. Clin Endocrinol Metab 85:4118-4124.
2. Reginster J, Minne HW, Sorenson OH, Hooper M, Roux C, Brandi ML, Lund B, Ethgen D, Pack S, Roumagnac I, Eastell R 2000 Randomized trial of the effects of residronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral efficacy with residronate therapy (VERT) study group. Osteoporos Int 11:83-91.
3. Harris ST, Watts NB, Genant HK, McKeever CD, Hangartner T, Keller M, Chestnut CH III, Brown J, Eriksen EF, Hoseyni MS, Axelrod DW, Miller PD 2000 Effects of residronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: A randomized controlled trial. Vertebral efficacy with residronate therapy (VERT) group. JAMA 11:1424-1425.
4. Ettinger B, Black DM, Mitlak BH, Knickerbocker RK, Nickelsen T, Genant HK, Christiansen C, Delmas, PD, Zanchetta JR, Stakkestad J, Gluer CC, Krueger K, Chen FJ, Eckert S, Ensrud KE, Avioli LV, Lips P, Cummings SR 1999 Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene. JAMA 282:537-645.
5. Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, Hodsman AB, Eriksen EF, Ish-Shalom S, Genant HK, Wang O, Mitlak BH 2001 Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 344:1434-1441.