Integrated model for denosumab and ibandronate pharmacodynamics in postmenopausal women

Biopharmaceutics and Drug Disposition

Volumn 32, Issue 8, 2011, Pages 471-481

  Marathe, Dhananjay D ^a   Marathe, Anshu ^b   Mager, Donald E ^b  

^a State University of New York   (United States)

^b UNIVERSITY AT BUFFALO   (United States)

Author keywords

Bisphosphonates; Bone mineral density; Bone remodeling; Denosumab; Pharmacodynamics

Indexed keywords

AMINO TERMINAL TELOPEPTIDE; CARBOXY TERMINAL TELOPEPTIDE; DENOSUMAB; IBANDRONIC ACID; OSTEOCLAST DIFFERENTIATION FACTOR; PLACEBO;

ADULT; ARTICLE; BONE DENSITY; BONE REMODELING; BONE TURNOVER; CELL STIMULATION; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG ELIMINATION; DRUG RECEPTOR BINDING; FEMALE; HUMAN; LUMBAR SPINE; NORMAL HUMAN; OSSIFICATION; OSTEOCLAST; OSTEOCLAST ACTIVITY; OSTEOLYSIS; PHARMACODYNAMICS; POSTMENOPAUSE; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE;

ANTIBODIES, MONOCLONAL; BIOMARKERS, PHARMACOLOGICAL; BONE AND BONES; BONE DENSITY; BONE DENSITY CONSERVATION AGENTS; COLLAGEN TYPE I; DIPHOSPHONATES; DOUBLE-BLIND METHOD; FEMALE; HOMEOSTASIS; HUMANS; MODELS, BIOLOGICAL; PEPTIDES; POSTMENOPAUSE; RANK LIGAND;

EID: 80054965069     PISSN: 01422782     EISSN: 1099081X     Source Type: Journal    
DOI: 10.1002/bdd.770     Document Type: Article

References (22)

1. National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. 2008.
2. Lewiecki EM. Managing osteoporosis: challenges and strategies. Cleve Clin J Med 2009; 76: 457-466. doi:10.3949/ccjm.76a.09019.
3. Filvaroff E, Derynck R. Bone remodelling: a signalling system for osteoclast regulation. Curr Biol 1998; 8: R679-R682. (Pubitemid 28451022)
4. Aubin JE, Bonnelye E. Osteoprotegerin and its ligand: A new paradigm for regulation of osteoclastogenesis and bone resorption. Medscape Womens Health 2000; 5: 5.
5. Boyle WJ, Simonet WS, Lacey DL. Osteoclast differentiation and activation. Nature 2003; 423: 337-342. (Pubitemid 40852708)
6. Clowes JA, Riggs BL, Khosla S. The role of the immune system in the pathophysiology of osteoporosis. Immunol Rev 2005; 208: 207-227. doi:10.1111/j.0105-2896.2005.00334.x. (Pubitemid 41746395)
7. Rodan GA, Martin TJ. Therapeutic approaches to bone diseases. Science 2000; 289: 1508-1514.
8. Pillai G, Gieschke R, Goggin T, Jacqmin P, Schimmer RC, Steimer JL. A semimechanistic and mechanistic population PK-PD model for biomarker response to ibandronate, a new bisphosphonate for the treatment of osteoporosis. Br J Clin Pharmacol 2004; 58: 618-631. doi:10.1111/j.1365-2125.2004.02224.x. (Pubitemid 39665149)
9. Bekker PJ, Holloway DL, Rasmussen AS, et al. A single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women. J Bone Miner Res 2004; 19: 1059-1066. (Pubitemid 41110556)
10. Lewiecki EM, Miller PD, McClung MR, et al. Twoyear treatment with denosumab (AMG 162) in a randomized phase 2 study of postmenopausal women with low BMD. J Bone Miner Res 2007; 22: 1832-1841. doi:10.1359/jbmr.070809. (Pubitemid 351229299)
11. Cremers SC, Pillai G, Papapoulos SE. Pharmacokinetics/ pharmacodynamics of bisphosphonates: use for optimisation of intermittent therapy for osteoporosis. Clin Pharmacokinet 2005; 44: 551-570. (Pubitemid 40994085)
12. Peterson MC, Riggs MM. A physiologically based mathematical model of integrated calcium homeostasis and bone remodeling. Bone 2009; 46: 49-63. doi:10.1016/j.bone.2009.08.053.
13. Marathe A, Peterson MC, Mager DE. Integrated cellular bone homeostasis model for denosumab pharmacodynamics in multiple myeloma patients. J Pharmacol Exp Ther 2008; 326: 555-562.
14. Pedrazzoni M, Girasole G, Bertoldo F, et al. Definition of a population-specific DXA reference standard in Italian women: the Densitometric Italian Normative Study (DINS). Osteoporos Int 2003; 14: 978-982. doi:10.1007/s00198-003-1521-1. (Pubitemid 40824273)
15. Lemaire V, Tobin FL, Greller LD, Cho CR, Suva LJ. Modeling the interactions between osteoblast and osteoclast activities in bone remodeling. J Theor Biol 2004; 229: 293-309. (Pubitemid 38844935)
16. D'Argenio DZ, Schumitzky A. ADAPT II User's Guide. Los Angeles, California: Biomedical Simulation Resource, 1997.
17. Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci 2004; 93: 2645-2668. (Pubitemid 39506617)
18. Bucay N, Sarosi I, Dunstan CR, et al. Osteoprotegerin-deficient mice develop early onset osteoporosis and arterial calcification. Genes Dev 1998; 12: 1260-1268. (Pubitemid 28213402)
19. Hoffman A, Goldberg A. The relationship between receptor-effector unit heterogeneity and the shape of the concentration-effect profile: pharmacodynamic implications. J Pharmacokinet Biopharm 1994; 22: 449-468.
20. Li Z, Chines AA, Meredith MP. Statistical validation of surrogate endpoints: is bone density a valid surrogate for fracture? J Musculoskelet Neuronal Interact 2004; 4: 64-74. (Pubitemid 38714796)
21. Seeman E. Is a change in bone mineral density a sensitive and specific surrogate of anti-fracture efficacy? Bone 2007; 41: 308-317. doi:10.1016/j.bone. 2007.06.010.
22. Sharma A, Jusko WJ. Characterization of four basic models of indirect pharmacodynamic responses. J Pharmacokinet Biopharm 1996; 24: 611-635. (Pubitemid 27406370)