The rhPTH (1-34), but not elcatonin, increases bone anabolic efficacy in postmenopausal women with osteoporosis.
OBJECTIVE
Intermittent administration of recombinant human PTH [rhPTH (1-34)] exerts an osteoanabolic effect characterized by direct effects on bone formation, increases bone density, and reduces fracture risk. This study was to investigate the anabolic effects of rhPTH(1-34) on postmenopausal osteoporosis in an Asian population and compare the time course and alteration in bone turnover marker (BTM) during rhPTH(1-34) and elcatonin treatment.


METHODS
124 women with postmenopausal osteoporosis were enrolled in this prospective, open-label, active-controlled trial. The patients randomized to subcutaneous rhPTH(1-34) (20 ug, once daily) or elcatonin (200U, once week) injections for 12 months. Biochemical markers of bone formation (bone specific alkaline phosphatase [BSAP]), and bone resorption maker (serum C-telopeptide of type I collagen [CTX-I] were measured at baseline and at 0, 6, and 12 months.


RESULTS
At 12 months, rhPTH (1-34) significantly increased lumbar spine BMD significantly compared with baseline, whereas elcatonin was ineffective. BSAP levels were gradually increased in almost all rhPTH(1-34)-treated subjects and at the end of the study, the percentage of subjects with BSAP above the postmenopausal reference interval was gradually increased as high as 91.5% at month 12. Opposite trends in percentages for CTX-I was observed in rhPTH(1-34). With rhPTH(1-34), but not elcatonin, there were significant positive correlations between ratio of BSAP and CTX-I and bone mineral density (BMD) (r=0.318) at the end of month 12. Both treatments were well tolerated and there were no significant differences detected between the 2 groups in the proportion of any adverse events and any serious adverse events.


CONCLUSIONS
rhPTH (1-34) has more positive effects on bone formation than elcatonin for postmenopausal women with osteoporosis and was proved to be safe and well tolerated. The ratio of BSAP and CTX-I may be a useful indicator for positive bone formation.
Department of Endocrinology, the Second Affiliated Hospital, Chongqing Medical University, Chongqing, China.
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L
Zhang
M
M
Yang
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D
Liu
C
C
Guo
L
L
Li
G
G
Yang
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D045930:Anabolic Agents / Q000494:pharmacology / Q000627:therapeutic use; D015519:Bone Density / Q000187:drug effects; D001842:Bone and Bones / Q000187:drug effects* / Q000378:metabolism; D002116:Calcitonin / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008660:Metabolism / Q000187:drug effects; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000378:metabolism*; D010281:Parathyroid Hormone / Q000494:pharmacology* / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000494:pharmacology / Q000627:therapeutic use; D016896:Treatment Outcome
D045930:Anabolic Agents; D010281:Parathyroid Hormone; D011994:Recombinant Proteins; D002116:Calcitonin; C012755:elcatonin