The purpose of this study is to determine if the loss of bone mass that occurs from immunosupressive therapy and glucocorticoid therapy in patients who receive liver transplants can be reduced with salmon calcitonin therapy. This double-blind, placebo controlled trial will determine if calcitonin therapy given to liver transplant patients for one year after transplant reduces bone loss in the lumber spine as measured by dual energy x-ray absorptiometry. Over the last year we have completed the outpatient evaluation of our 15 patients who have completed the study protocol. The study has gone on for six years and we have been able to enroll 19 patients but only 15 patients have completed the protocol. Because of the great difficulties in recruiting subjects we have decided to terminate the study and are in the process of analyzing the data. We attribute the difficulty in acquiring subjects for this study to be caused by several facts. First, osteoporosis is a silent disease and many patients contemplating orthotopic liver transplantation do not wish to hear about another health problem as they face thier surgery, the problem being osteoporosis which is asymptomatic and not a problem for them. Second, patients are unwilling to commit to using a daily subcutaneous injection of calcitonin. This has been a problem with calcitonin use for the treatment of osteoporosis for years and has resulted over the last year and a half in the development and approval by the FDA of nasal calcitonin. Unfortunately, this was not available at the beginning of the study and therefore it was impossible to use this study medication once it became available. For this reason, we have decided to close the study and will notify the Institutional Review Board at Duke University Medical Center once the data analysis is complete.
| Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201 |
| Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445 |
| Denson, Lee A; McDonald, Scott A; Das, Abhik et al. (2017) Early Elevation in Interleukin-6 is Associated with Reduced Growth in Extremely Low Birth Weight Infants. Am J Perinatol 34:240-247 |
| James, Jennifer; Munson, David; DeMauro, Sara B et al. (2017) Outcomes of Preterm Infants following Discussions about Withdrawal or Withholding of Life Support. J Pediatr 190:118-123.e4 |
| Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628 |
| Archer, Stephanie Wilson; Carlo, Waldemar A; Truog, William E et al. (2016) Improving publication rates in a collaborative clinical trials research network. Semin Perinatol 40:410-417 |
| Ahmed, Zuhayer; Prasad, Indrajit; Rahman, Hafizur et al. (2016) A Male with Extreme Subcutaneous Insulin Resistance: A Case Report. Rom J Diabetes Nutr Metab Dis 23:209-213 |
| Phelps, Dale L; Ward, Robert M; Williams, Rick L et al. (2016) Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants. Pediatr Res 80:209-17 |
| Barroso, Julie; Leserman, Jane; Harmon, James L et al. (2015) Fatigue in HIV-Infected People: A Three-Year Observational Study. J Pain Symptom Manage 50:69-79 |
| Stafford-Smith, Mark; Li, Yi-Ju; Mathew, Joseph P et al. (2015) Genome-wide association study of acute kidney injury after coronary bypass graft surgery identifies susceptibility loci. Kidney Int 88:823-32 |
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