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.