Abstract
Purpose: To evaluate the efficacy and safety of teriparatide and hyaluronic-calcitonin combination treatment in Chinese osteoporotic patients with risk of bone fracture.Methods: Osteoporotic patients aged 30 to 80 years, with at least one vertebral fracture and immediate risk of new vertebral fractures, were recruited from Hangzhou First People's Hospital. They were randomly assigned to two groups (50/group) treated with either teriparatide (20 μg/day) or hyaluronic acid + calcitonin (1:1 ratio, 200 IU daily) for 12 months. The patients were followed up every 3 months. Bone mineral density (BMD) was evaluated using x-ray absorptiometry. The proportion of patients with new fractures was recorded. Changes in serum osteocalcin and serum bone alkaline phosphatase (BSAP) from baseline to endpoint were also measured.Results: Treatment with teriparatide at a dose of 20 μg/day resulted in a significant reduction in the proportion of patients with new fractures (p < 0.05), when compared to patients treated with a combination of hyaluronic acid + calcitonin (200 IU daily). Teriparatide treatment for 12 months resulted in significant increase in lumbar BMD. Significant increases in spine BMD were evident after 3 months of treatment. There were significantly greater increases in serum osteocalcin and BSAP levels in teriparatide-treated patients than in those given hyaluronic acid + calcitonin. The most common treatment adverse event reported by both sexes was dizziness.Conclusion: These results demonstrate that teriparatide is efficacious and well tolerated in Chinese men and post-menopausal women with osteoporosis, when compared to the combination of hyaluronic acid and calcitonin. The efficacy of teriparatide is not associated with gender differences.
 Keyword: Teriparatide, Calcitonin, Hyaluronic acid, Bone-specific alkaline phosphatase, Postmenopausal, Bone mineral density
Highlights
Osteoporosis is one of the key causes of vertebral/non-vertebral fracture, especially in elderly people: every year, more than 1 million fractures in the Unites States are due to osteoporosis [1,2,3]
Treatment with teriparatide at a dose of 20 μg/day resulted in statistically significant reduction in the proportion of patients with new fractures, when compared to patients treated with combination of hyaluronic acid + calcitonin at a dose of 200 IU daily (Table 2)
Treatment with teriparatide at a dose of 20 μg/day (LS mean: 8.2) for 12 months resulted in statistically significant increases in lumbar Bone mineral density (BMD), when compared with patients treated with CA +HA (LS mean: 1.2), with LSM diff. (f95% CI) of 7.1 (6.2, 7.7; p
Summary
Osteoporosis is one of the key causes of vertebral/non-vertebral fracture, especially in elderly people: every year, more than 1 million fractures in the Unites States are due to osteoporosis [1,2,3]. Several studies have focused mainly on women due to higher prevalence of bone fractures. Osteoporosis-related mortality is higher in men than in women [6,7,8]. Teriparatide is an anti-resorptive agent usually applied in management of osteoporosis [9,10,11]. Several reports have shown that patients treated with teriparatide (20 μg) had more than 60 % reduction in the occurrence of bone fractures and reduction in the occurrence of non-traumatic fractures, relative to placebo-treated patients [1214]. Other studies reported that combination of teriparatide with hormone replacement therapy (HRT) significantly increased BMD in postmenopausal women, when compared to HRT [15,16,17,18]. Teriparatide at the dose of 20 μg, is effective and well tolerated in the management of osteoporosis
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