Treatment of osteoporosis in men with fluoride alone or in combination with bisphosphonates

Alendronate has been approved as a first antiresorptive drug for treatment of osteoporosis in men. Except for fluoride, in some countries so far there has been no approved anabolic substance for the treatment of male osteopor osis. From small studies in men and male patients included in studies on po stmenopausal osteoporosis there is sufficient evidence that fluoride has th e same osteoblast-stimulating potency in men and women. In our own study on 64 men with idiopathic osteoporosis without prevalent fractures, a low-dos e intermittent fluoride regimen (15 mg fluoride ions 3 months on, 1 month o ff) resulted in an average gain of lumbar spine BMD of 3% per year and a lo wer rate of incident fractures as compared with patients treated with calci um only. A combination of fluoride with an antiresorptive drug may improve the therapeutic results in terms of pattern of biochemical marker response and gain in BMD. This was shown for postemopausal osteoporosis in several s tudies using fluoride and hormone replacement therapy (HRT). Encouraged by a Dutch study using etidronate/fluoride in corticoid-induced osteoporosis, we performed a pilote study in 33 men with severe established primary osteo porosis giving cyclically etidronate for 14 days followed by fluoride plus calcium/vitamin D for 76 days. This combined regimen resulted in significan tly higher increases of BMD than fluoride or etidronate alone. In an ongoin g trial we are studying a continuous, combined treatment of alendronate and fluoride plus calcium/vitamin D in established idiopathic osteoporosis in men. The results of a preliminary evaluation look very promising. A large s tudy with a bisphosphonate plus fluoride, taking fractures as the primary e ndpoint and bone biopsies to assess safety, would be very valuable.