A Randomized Trial of Nasal Spray Salmon Calcitonin in Men With Idiopathic Osteoporosis: Effects on Bone Mineral Density and Bone Markers

In a 12‐month randomized, double‐blind, placebo‐controlled trial, we have studied the effects of intranasal salmon calcitonin (SCT) on bone mineral density (BMD) and biochemical markers of bone turnover. Twenty‐eight men with idiopathic osteoporosis aged 27‐74 years (mean, 52.4 years) were randomized to receive either nasal SCT (200 IU) or a nasal placebo daily for a period of 1 year. All the men received a daily supplement of 0.5 g of calcium. The men who received SCT had a mean (±SEM) increase in BMD of 7.1 ± 1.7% at the lumbar spine. In contrast, the men who received the placebo had an increase of 2.4 ± 1.5% (p> 0.05) for the comparison with baseline. The increase in lumbar BMD in the calcitonin group was significantly greater than that in the placebo group (p< 0.05). There were no significant changes in the femoral neck, trochanter, or Ward's triangle relative to both baseline and placebo after 12 months. Treatment with nasal SCT resulted in a significantly pronounced suppression of bone resorption markers (urinary deoxypyridinoline [DPD], type I cross‐linked N‐telopeptide [NTX], and type I cross‐linked C‐telopeptide [CTX]) and to a lesser extent in bone formation markers (serum bone‐specific alkaline phosphatase [BALP], osteocalcin [OC], serum C‐terminal procollagen type I extension peptides [PICP], and serum N‐terminal procollagen type I extension peptides [PINP]), whereas the placebo did not. Therapy was tolerated well and there were no treatment‐related adverse events. We conclude that intranasal SCT (200 IU daily) is safe and effective in increasing lumbar BMD and reducing bone turnover in men with idiopathic osteoporosis.