Randomized Prospective Study of Pamidronate for Prevention of Bone Loss in Men Undergoing Hormonal therapy for Prostate Cancer
Matthew R. Smith, M.D., PhD,
Harvard Medical School, Cambridge,
MA, USA

Summary: Treatment with gonadotropin-releasing hormone agonists significantly decreases bone mineral density in men with prostate cancer. However, concurrent administration of pamidronate has been shown to prevent treatment-related bone loss.

Dr. Smith said osteoporosis in men could be called an "orphan disease" because so little is known about it compared with the condition in women. Yet one third of hip fractures in the general. population occurs in men, accounting for $4 billion in health care costs.

In addition, men taking hormonal treatment for prostate cancer lose bone density---actually more than the average postmenopausal woman. Hormonal therapy leads to increased fracture rates in these men, but there have been no previous clinical trials to test remedies for the problem.

Dr. Smith and his colleagues set up a randomized, open-label study in 43 men with advanced, node-positive, or recurrent prostate cancer. Men with bone metastases or secondary causes of osteoporosis were excluded. The mean age of patients was 67 (+/- 10 years). Baseline characteristics of men in both groups were the same, including some deficiencies in calcium and vitamin D intakes.

One group of patients was given 22.5 mg of leuprolide (a gonadotropin-releasing hormone agonist) intramuscularly every 12 weeks. A second group was given the leuprolide plus a standard 60 mg dose of pamidronate intravenously on the same schedule. Both groups received calcium and vitamin D supplements.

After one year, bone mineral density was measured by dual energy x-ray absorptiometry and quantitative computed tomography. The men who received leuprolide alone had a mean decrease in bone mineral density of 3.3% at the lumbar spine (by absorptiometry), 1.8% at the total hip (by absorptiometry), and 7.8% at the lumbar spine by (by computed tomography). However, men who took both leuprolide and pamidronate had no significant bone loss during that period.

Dr. Smith suggested that men prescribed hormone therapy for prostate cancer should have bone mineral density tested. If baseline levels are low, treatment with pamidronate might begin immediately. Alternatively, pamidronate could be started if a loss in bone density becomes evident during treatment.


Reporter: Aaron Levin
 


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