Also, the study population in an observational study may be larger and more diverse compared with the study population in a randomized clinical trial. The data reported from this study, which examined the use of TPTD in a real-world clinical Selonsertib solubility dmso setting, complement and add to previously published data regarding the effectiveness of TPTD treatment on the reduction of NVFX. However, caution should be used in interpretation of the results due to lack of an untreated control group. this website Conclusions
Overall, the results of this observational study indicate that the incidence of new NVFX decreased for patients receiving TPTD treatment for durations of longer than 6 months compared with the baseline reference time period (>0 to ≤6 months of treatment) and that this improvement persisted throughout the 24-month cessation phase. There were no new safety findings observed among patients who received one or more dose of TPTD over the 24-month treatment period or for 24 months after treatment cessation. This learn more study is consistent with other clinical and observational trials that have shown that a treatment period of greater than 6 months with TPTD is associated with an increased benefit in reducing the incidence of NVFX. Acknowledgments This work was sponsored by Eli Lilly and/or one of its subsidiaries. The authors extend their sincere thanks to all of
the DANCE investigators and study coordinators for
their dedicated work on this study. Writing assistance was provided by Rapamycin Eileen R. Gallagher, a full-time employee of PharmaNet/i3, a part of the inVentiv Health Company. Conflicts of interest S.S. is on the Speaker’s Bureau and is a consultant for and has received research support from Eli Lilly; P.M. has received research grants and consulting fees from Eli Lilly; S.S. has no conflicts to disclosure; M.W. is on the Speaker’s Bureau and involved in clinical trials with Eli Lilly; X.W., D.M., K.A.T., V.A.R., and K.K. are employees of Eli Lilly and Company and or/one of its subsidiaries and own stock in the company. J.A. is an employee of Lilly USA, LLC. Open Access This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. References 1. Neer RM, Arnaud CD, Zanchetta JR et al (2001) Effect of parathyroid hormone (1–34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 344:1434–1441PubMedCrossRef 2. Lindsay R, Miller P, Pohl G, Glass EV, Chen P, Krege JH (2009) Relationship between duration of teriparatide therapy and clinical outcomes in postmenopausal women with osteoporosis. Osteoporos Int 20:943–948PubMedCrossRef 3.