Document Detail

Relationship between duration of teriparatide therapy and clinical outcomes in postmenopausal women with osteoporosis.
MedLine Citation:
PMID:  18923884     Owner:  NLM     Status:  In-Process    
SUMMARY: The extent to which fracture protection and safety varies with increasing time on teriparatide [rhPTH(1-34)] therapy is a clinically relevant unanswered question. In postmenopausal women with osteoporosis, increased duration of teriparatide versus placebo treatment was associated with a progressive decrease in the rates of nonvertebral fragility fractures and back pain. INTRODUCTION: The impact of duration of teriparatide [rhPTH(1-34)] therapy on patient outcomes is a relevant unanswered question. METHODS: Postmenopausal women with osteoporosis were randomized to once-daily subcutaneous injection with placebo (N = 544), teriparatide 20 microg (TPTD20; N = 541), or teriparatide 40 microg (TPTD40; N = 552) plus calcium and vitamin D supplementation. The time to first nonvertebral fragility fracture and new or worsening back pain following treatment initiation was analyzed using Cox partial likelihood regression treating time on therapy as a linear, time-dependent covariate. RESULTS: Compared with placebo, the relative hazard for nonvertebral fragility fractures decreased by 7.3% for each additional month of TPTD20 [hazard ratio = 0.927, 95% CI (0.876 to 0.982), p = 0.009] and by 7.6% for each additional month of TPTD40 [hazard ratio = 0.924, 95% CI (0.871 to 0.981), p = 0.009]. Clinical vertebral fractures appeared to increase over time in the placebo group and occurred primarily in the first time interval in the teriparatide treatment groups. Compared with placebo, the relative hazard of back pain was decreased by 8.3% for each additional month of TPTD20 [hazard ratio = 0.920, 95% CI (0.902 to 0.939), p < 0.001] and 8.7% for each additional month of TPTD40 [hazard ratio = 0.917, 95% CI (0.898 to 0.935), p < 0.001]. CONCLUSIONS: These findings suggest increased nonvertebral fracture protection, reduced back pain, and reduced occurrence of side effects with longer duration of teriparatide therapy.
R Lindsay; P Miller; G Pohl; E V Glass; P Chen; J H Krege
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2008-10-16
Journal Detail:
Title:  Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA     Volume:  20     ISSN:  1433-2965     ISO Abbreviation:  Osteoporos Int     Publication Date:  2009 Jun 
Date Detail:
Created Date:  2009-05-11     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9100105     Medline TA:  Osteoporos Int     Country:  England    
Other Details:
Languages:  eng     Pagination:  943-8     Citation Subset:  IM    
Helen Hayes Hospital, West Havershaw, NY, USA.
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