Letter to the Editor

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Letter to the editor:

115 2011 Volume 16 No 2 JEMDSA

What happens to hip fracture patients in placebo-controlled trials for osteoporosis?

Hip fracture patients are removed from the trials and treated by their own private doctors, hopefully also for osteoporosis.

One will never see any hip fracture mortality figures in any placebo controlled osteoporosis trial.

^1–6

The average fracture risk reduction resulting from the use of all osteoporosis drugs is in the region of 50%. Hip fractures are associated with an overall 12–20% mortality reduction, from expected survival.

^7,8

The number of hip fracture patients in the placebo group would be double compared to that in the treatment group, and hence the mortality rate would also be expected to be higher.

Placebo-controlled trials in osteoporosis are unethical, and new drugs should be compared to existing drugs.

⁹

Dr AJ de Weerd, MBChB, MMed (O et G)(UOVS) Private Practitioner, Pretoria East Hospital e-mail: [email protected]

References

1. McClung MR, Geusens P, Miller PD, et al. Effect of risedronate on the risk of hip fracture in elderly women. N Engl J Med. 2001;344:333-340.

2. Cummings SR, Black DM, Thompson DE, et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures. Results from the Fracture Intervention Trial. J Am Med Assoc.

1998;280:2077-2082.

3. Black DM, Thompson DE, Bauer DC, et al. Fracture risk reduction with alendronate in woman with osteoporosis: the Fracture Intervention Trial. J Clin Endocrinol Metab. 2000;85:4118-4124.

4. Chesnut CH, Silverman S, Adriano K, et al. A randomized trial of nasal spray salmon calcitonin in postmenopausal woman with established osteoporosis:

the Prevent Recurrence of Osteoporotic Fractures Study. Am J Med.

2000;109:267-276.

5. Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of parathyroid hormone (1- 34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Eng J Med. 2001;344:1434-1441.

6. Delmas PD, Ensrud KE, Adachi JD, et al. Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis:

four-year results from a randomized clinical trial. J Clin Endocrinol Metab.

2002;87:3609-3617.

7. Cooper C, Atkinson EJ, Jacobsen SJ, et al. Population-based study of survival after osteoporotic fractures. Am J Epidemiol. 1993;137:1001-1005.

8. Cummings SR, Black DM, Rubin SM. Lifetime risks of hip, Colles’, or vertebral fracture and coronary heart disease among white postmenopausal women.

Arch Intern Med. 1989;149:2445-2448.

9. WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, 1964. Amended October 2008. Available from:

http://www.wma.net/en/30publications/10policies/b3/index.html