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J. Thromb. Haemost. · Aug 2007
Randomized Controlled TrialLong-term dalteparin in pregnancy not associated with a decrease in bone mineral density: substudy of a randomized controlled trial.
- M A Rodger, S R Kahn, A Cranney, A Hodsman, M J Kovacs, A M Clement, A Lazo-Langner, W M Hague, and TIPPS investigators.
- Ottawa Health Research Institute, University of Ottawa, Ottawa, ON, Canada. mrodger@ohri.ca
- J. Thromb. Haemost. 2007 Aug 1;5(8):1600-6.
BackgroundThe risk of decreased bone mineral density (BMD) with prophylactic dose long-term low-molecular-weight heparin (LMWH) is unknown.ObjectivesWe sought to determine whether long-term prophylactic dalteparin in pregnancy leads to loss of BMD.Patients/MethodsPatients in a substudy of an ongoing multicenter randomized trial investigating the effect of antepartum dalteparin prophylaxis on pregnancy outcomes in thrombophilic pregnant women were randomized to either dalteparin 5000 U s.c. daily until 20 weeks and then 5,000 U s.c. q12 h until >37 weeks or to the control group. The primary outcome was absolute spine BMD at six weeks postpartum.ResultsOf 77 patients eligible for the BMD substudy, 62 were analyzed. 33 patients received a mean of 212 days of dalteparin in the intervention group. 29 patients received a mean of 38 days of postpartum dalteparin in the control group. There was no difference in mean BMD between the intervention (1.11 g cm(-2)) and the control groups (1.14 g cm(-2)). Similarly, there was no difference in T-scores; the difference of -0.34 (95% confidence interval -0.93 to +0.25) in favor of the control group excludes a clinically important increase in fracture risk.ConclusionsOur results suggest that the use of long-term prophylactic dalteparin in pregnancy is not associated with a significant decrease in BMD.Clinical Trial RegistrationISRCTN87441504 at http://www.controlled-trials.com.
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