|
KMID : 1007020050030020110
|
|
Korean Soceity of Osteroporosis
2005 Volume.3 No. 2 p.110 ~ p.120
|
|
|
Compatison of Teriparatide and Calcitonin Treatment in Postmenopausal Korean Women with Osteoporosis
|
|
Choi Woong-Hwan
Kim Ghi-Su
Min Yong-Ki
Kang Moo-Il
Daniel Thiebaud
Belinda J Hall
Yu Maria
Lim Sung-Kil
Yoon Hyun-Koo
Shin Chan-Soo
|
|
|
Abstract
|
|
|
Objectives: The objectives of this study were to compare the effects of teriparatide and calcitonin treatment on changes in lumbar spine and hip bone mineral density (BMD), changes in biochemical bone markers (bone-specific alkaline phosphatase [BSAP] and osteocalcin), and safety in postmenopausal women with established osteoporosis.
Methods: In this open-label, multicenter, controlled trial conducted in Korea, 70 postmenopausal women with osteoporosis were randomised to receive teriparatide 20μg/day (n=35) or calcitonin 100 IU/day (n= 35) subcutaneously for 6 months. All patients received calcium (≥500 mg/day) and vitamin D (200 to 400 IU/day) supplements throughout the study.
Results: All randomised patients were Korean, aged between 55 and 82 years (66±5 years; mean± SD) with at least one previous fracture. From the teriparatide group, 31 (89%) patients completed the protocol compared with 23 (66%) patients from the calcitonin group (P=.044). Lumbar spine BMD increased by 4.2±5.9% (mean±SD; P＜.001) with teriparatide treatment and by 0.6±5.5% (mean±SD; P=.555) with calcitonin treatment. The adjusted mean difference between the two treatment groups for the percent change from baseline to endpoint in lumbar spine BMD was 3.8% (95% CI: 0.94～6.57, P=0.10). Teriparatide treatment had no statistically significant effect on the percent change in total hip (P=.658), trochanter (P=.056), or femoral neck (P=.442) BMD. Calcitonin treatment resulted in a slight yet statistically significant decrease of 2.2±4.6% (mean±SD; P=.029) in total hip BMD, while having no statistically significant effect on trochanter (P=.641) or femoral neck (P=.216) BMD. Teriparatide treatment resulted in serum levels of bone-specific alkaline phosphatase (BSAP) and osteocalcin increasing by 116% (median change, range -31 to 599%; P＜.001) and 172% (median change, range -62 to 571%; P＜.001) from baseline respectively. Calcitonin treatment had no statistically significant effect on serum levels of BSAP or osteocalcin. From the teriparatide treatment group, 69% of patients experienced at least one treatmentemergent adverse event (TEAE) compared with 85% from the calcitonin treatment group (P=.154). The most common TEAE with both treatments was nausea, and this was reported by more patients in the calcitonin group compared with the teriparatide group (41% versus 17% respectively; P=.036). No clinically significant changes in laboratory values or vital signs were observed in either of the teatment groups.
Conclusion: This study shows that teriparatide is an effective treatment for osteoporosis in postmenopausal Korean women as measured by an increase in lumbar spine BMD as well as increases in the levels of biochemical markers of bone formation, BSAP and osteocalcin. Treatment with teriparatide produced a significantly greater increase in lumbar spine BMD than calcitonin treatment. Both treatments were safe and well tolerated in this patient population.
|
|
|
KEYWORD
|
|
|
Teriparatide, Calcitonin, Osteoporosis, Postmenopausal Women
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|