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Integrated Model for Denosumab:
Pharmacodynamics in
Postmenopausal Women
Diana Ramos, Mentor: Dr. D’Argenio
University of Southern California, USC Viterbi School of Engineering
Department of Biomedical Engineering
2015 USC Gateway/McNair Scholars Program
Osteoporosis
• Bone disease
• Affects 10 million Americans
• 80% are women
• Silent disease
• 43.1 million have low bone
density
Healthy Bone Osteoporosis
Figure 1
Specific Aims
• Implement a computational model for the model-based drug
development that might improve the evaluation of osteoporosis
therapies, leading to better treatment and prevention
• Investigate the effects of disease progression with a regimen of
different doses of Denosumab, due to the up-regulation of
RANKL on changes in bone mineral density
• Explore dose adjustments needed to compensate for the
percent decrease in bone mineral density due to changes in
RANKL
Materials and Methods
Figure 2: Bone homeostasis model
Results
98
100
102
104
106
108
110
112
0 200 400 600 800 1000 1200 1400 1600
ChangefrombaselineinlumbarspineBMD(%)
Time (days)
Bone Mineral Density: multiple dosing of
Denosumab
1ng
30 ng
Figure 3
98
100
102
104
106
108
110
112
0 500 1000 1500 2000
Changefrombaselinein
lumbarspineBMD(%)
Time(days)
Disease Progression of Osteoporosis
Klp = 0.3
Klp=1.5
Klp=2.0
Results
Figure 4: Dose 1ng
% Increase in BMD= 5.18
98
100
102
104
106
108
110
0 500 1000 1500 2000
Changefrombaselineinlumbarspine
BMD(%)
Time (days)
Dose adjustments needed to
compensate for decrease in BMD
Dose = 1ng, Klp= 2.0
Dose = 4ng, Klp= 2.0
Figure 5
Conclusion
Future Work
• Exploring the effects of a deficiency in Vitamin D
and/ or estrogen levels with a linked bone
homeostasis model
• Model effectively predict changes in BMD for
postmenopausal women
• Ability to identify clinical endpoints in the treatment
of osteoporosis
• Provides a platform for testing various variables that
regulate drug response and disease progression
Acknowledgements
This study was supported by Dr. D’Argenio,
Professor of Biomedical Engineering at the University of
Southern California.
I would also like to thank my 2014-2015 USC
McNair/Gateway Scholar Cohort.
References
• Marathe, Anshu, Mark C. Peterson, and Donald E. Mager. "Integrated
Cellular Bone Homeostasis Model for Denosumab Pharmacodynamics
in Multiple Myeloma Patients." The Journal of pharmacology and
experimental therapeutics 326.2 (2008): 555-62. ProQuest. Web. 16
June 2015.
• Marathe, Dhananjay D., Anshu Marathe, and Donald E. Mager.
"Integrated Model for Denosumab and Ibandronate Pharmacodynamics
in Postmenopausal Women." Biopharmaceutics & drug disposition 32.8
(2011): 471-81. ProQuest. Web. 16 June 2015.
• Lemaire, Vincent, et al. "Modeling the Interactions between Osteoblast
and Osteoclast Activities in Bone Remodeling." Journal of theoretical
biology 229.3 (2004): 293-309. ProQuest. Web. 17 June 2015.

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2015 USC Gateway-McNair Scholars Program Research Presentation

  • 1. Integrated Model for Denosumab: Pharmacodynamics in Postmenopausal Women Diana Ramos, Mentor: Dr. D’Argenio University of Southern California, USC Viterbi School of Engineering Department of Biomedical Engineering 2015 USC Gateway/McNair Scholars Program
  • 2. Osteoporosis • Bone disease • Affects 10 million Americans • 80% are women • Silent disease • 43.1 million have low bone density Healthy Bone Osteoporosis Figure 1
  • 3. Specific Aims • Implement a computational model for the model-based drug development that might improve the evaluation of osteoporosis therapies, leading to better treatment and prevention • Investigate the effects of disease progression with a regimen of different doses of Denosumab, due to the up-regulation of RANKL on changes in bone mineral density • Explore dose adjustments needed to compensate for the percent decrease in bone mineral density due to changes in RANKL
  • 4. Materials and Methods Figure 2: Bone homeostasis model
  • 5. Results 98 100 102 104 106 108 110 112 0 200 400 600 800 1000 1200 1400 1600 ChangefrombaselineinlumbarspineBMD(%) Time (days) Bone Mineral Density: multiple dosing of Denosumab 1ng 30 ng Figure 3
  • 6. 98 100 102 104 106 108 110 112 0 500 1000 1500 2000 Changefrombaselinein lumbarspineBMD(%) Time(days) Disease Progression of Osteoporosis Klp = 0.3 Klp=1.5 Klp=2.0 Results Figure 4: Dose 1ng % Increase in BMD= 5.18 98 100 102 104 106 108 110 0 500 1000 1500 2000 Changefrombaselineinlumbarspine BMD(%) Time (days) Dose adjustments needed to compensate for decrease in BMD Dose = 1ng, Klp= 2.0 Dose = 4ng, Klp= 2.0 Figure 5
  • 7. Conclusion Future Work • Exploring the effects of a deficiency in Vitamin D and/ or estrogen levels with a linked bone homeostasis model • Model effectively predict changes in BMD for postmenopausal women • Ability to identify clinical endpoints in the treatment of osteoporosis • Provides a platform for testing various variables that regulate drug response and disease progression
  • 8. Acknowledgements This study was supported by Dr. D’Argenio, Professor of Biomedical Engineering at the University of Southern California. I would also like to thank my 2014-2015 USC McNair/Gateway Scholar Cohort.
  • 9. References • Marathe, Anshu, Mark C. Peterson, and Donald E. Mager. "Integrated Cellular Bone Homeostasis Model for Denosumab Pharmacodynamics in Multiple Myeloma Patients." The Journal of pharmacology and experimental therapeutics 326.2 (2008): 555-62. ProQuest. Web. 16 June 2015. • Marathe, Dhananjay D., Anshu Marathe, and Donald E. Mager. "Integrated Model for Denosumab and Ibandronate Pharmacodynamics in Postmenopausal Women." Biopharmaceutics & drug disposition 32.8 (2011): 471-81. ProQuest. Web. 16 June 2015. • Lemaire, Vincent, et al. "Modeling the Interactions between Osteoblast and Osteoclast Activities in Bone Remodeling." Journal of theoretical biology 229.3 (2004): 293-309. ProQuest. Web. 17 June 2015.