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In a recent overview of current and potential future drug treatments for osteoporosis, the therapies for osteoporosis in men were discussed briefly.1 Osteoporosis in men is a heterogeneous disease of which 50% of the cases are classified as idiopathic osteoporosis (IOP).2 Long term data on treatment of men with IOP are not yet available.
In an uncontrolled open study of 22 white men with IOP, we have studied prospectively, the effect of a two year treatment with cyclic etidronate (400 mg/d during two weeks every three months) and calcium (500 mg/d during 10 weeks every three months). All patients were extensively screened to exclude any causes of secondary osteoporosis, such as hypogonadism and hypercalciuria, or any other risk factors. Liver function tests were normal in all patients and there was no excessive alcohol consumption either. Bone mineral density (BMD) measurements were performed every six months in the lumbar spine (L2-L4) and in the femoral neck, using dual energy x ray absorptiometry. Precision was <1% in the spine and <2% in the femoral neck. Results are expressed as mean (SEM). Per cent changes from baseline were analysed by a paired t test. Patients with vertebral fractures or a T score of < −2 in the lumbar spine, or both were included (a T score of 1 being the number of standard deviations from the mean bone density of young healthy controls). Mean (SD) age of the patients was 56 (2) years. Seventeen patients showed fractures of vertebrae (one fracture in seven patients and ≥ two in 10 patients) and 11 patients of the appendicular skeleton (one fracture in eight patients and ≥ two in three patients).
Mean T score was −3.2 (0.3) (range −5.4 to −0.6) in the spine and −2.8 (0.2) (range −5.0 to −0.5) in the femoral neck. After two years of treatment with cyclic etidronate, intention to treat analysis indicated an increase in BMD of +7.3 (1.1)% in the spine (p<0.001) and of +2.4 (1.2)% in the hip (p<0.05) (fig 1). The increase of BMD in the spine was similar if patients with spinal fractures (n=8) were excluded (+7.9 (2.0), p<0.01).
The significant increase of BMD in the spine during cyclic etidronate therapy is comparable to the treatment effect in postmenopausal osteoporosis.3 This is the first study to indicate that cyclic etidronate can significantly increase BMD in the hip of men with IOP and substantial bone loss.
This study suggests that cyclic etidronate may be valuable in men with IOP, although double blind controlled prospective studies, with long term follow up are necessary to adequately assess this. In addition, whether cyclic etidronate will beneficially influence fracture rates in men will probably remain unknown, as large groups of patients are required to study this effect and as osteoporosis is less frequent in men than in women.
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