drugset / Trial / NCT00145977
Texture Analysis for Postmenopausal Osteoporosis
Completed
36 enrolled
University of Chicago
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · collabNational Institutes of Health (NIH) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine if a new test for osteoporosis can be useful in monitoring treatment. We are studying a new method for examining the quality of bone by an experimental method of computerized analysis of radiographic images (x-ray pictures) of the heel.
Timeline
- Start
- 2001-07
- Primary completion
- 2009-12
- Completion
- 2009-12
Publications
- Background Genant HK, Engelke K, Fuerst T, Gluer CC, Grampp S, Harris ST, Jergas M, Lang T, Lu Y, Majumdar S, Mathur A, Takada M. Noninvasive assessment of bone mineral and structure: state of the art. J Bone Miner Res. 1996 Jun;11(6):707-30. doi: 10.1002/jbmr.5650110602. No abstract available.
- Background Melton LJ 3rd, Eddy DM, Johnston CC Jr. Screening for osteoporosis. Ann Intern Med. 1990 Apr 1;112(7):516-28. doi: 10.7326/0003-4819-112-7-516.
- Background Melton LJ 3rd, Atkinson EJ, O'Fallon WM, Wahner HW, Riggs BL. Long-term fracture prediction by bone mineral assessed at different skeletal sites. J Bone Miner Res. 1993 Oct;8(10):1227-33. doi: 10.1002/jbmr.5650081010.
- Background National Osteoporosis Foundation: Physicians guide to prevention and treatment of osteoporosis, . 1999, Exerpta Medica, Inc.: Belle Mead, New Jersey.
- Background Cummings SR, Black DM, Nevitt MC, Browner W, Cauley J, Ensrud K, Genant HK, Palermo L, Scott J, Vogt TM. Bone density at various sites for prediction of hip fractures. The Study of Osteoporotic Fractures Research Group. Lancet. 1993 Jan 9;341(8837):72-5. doi: 10.1016/0140-6736(93)92555-8.
- Background Marshall D, Johnell O, Wedel H. Meta-analysis of how well measures of bone mineral density predict occurrence of osteoporotic fractures. BMJ. 1996 May 18;312(7041):1254-9. doi: 10.1136/bmj.312.7041.1254.
- Background Melton LJ 3rd, Kan SH, Frye MA, Wahner HW, O'Fallon WM, Riggs BL. Epidemiology of vertebral fractures in women. Am J Epidemiol. 1989 May;129(5):1000-11. doi: 10.1093/oxfordjournals.aje.a115204.
- Background Ross PD, Wasnich RD, Davis JW. Fracture prediction models for osteoporosis prevention. Bone. 1990;11(5):327-31. doi: 10.1016/8756-3282(90)90088-g.
- Background Wasnich RD, Davis JW, Ross PD. Appropriate clinical application of bone density measurements. J Am Med Womens Assoc (1972). 1990 May-Jun;45(3):99-102.
- Background Parfitt AM. Trabecular bone architecture in the pathogenesis and prevention of fracture. Am J Med. 1987 Jan 26;82(1B):68-72. doi: 10.1016/0002-9343(87)90274-9.
- Background Link TM, Majumdar S, Grampp S, Guglielmi G, van Kuijk C, Imhof H, Glueer C, Adams JE. Imaging of trabecular bone structure in osteoporosis. Eur Radiol. 1999;9(9):1781-8. doi: 10.1007/s003300050922.
- Background Jiang C, Giger ML, Chinander MR, Martell JM, Kwak S, Favus MJ. Characterization of bone quality using computer-extracted radiographic features. Med Phys. 1999 Jun;26(6):872-9. doi: 10.1118/1.598604.
- Background Caligiuri P, Giger ML, Favus MJ, Jia H, Doi K, Dixon LB. Computerized radiographic analysis of osteoporosis: preliminary evaluation. Radiology. 1993 Feb;186(2):471-4. doi: 10.1148/radiology.186.2.8421753.
- Background Caligiuri P, Giger ML, Favus M. Multifractal radiographic analysis of osteoporosis. Med Phys. 1994 Apr;21(4):503-8. doi: 10.1118/1.597390.
- Background Chinander MR, Giger ML, Martell JM, Jiang C, Favus MJ. Computerized radiographic texture measures for characterizing bone strength: a simulated clinical setup using femoral neck specimens. Med Phys. 1999 Nov;26(11):2295-300. doi: 10.1118/1.598743.
- Background Chinander MR, Giger ML, Martell JM, Favus MJ. Computerized analysis of radiographic bone patterns: effect of imaging conditions on performance. Med Phys. 2000 Jan;27(1):75-85. doi: 10.1118/1.598858.
- Background Benhamou CL, Lespessailles E, Jacquet G, Harba R, Jennane R, Loussot T, Tourliere D, Ohley W. Fractal organization of trabecular bone images on calcaneus radiographs. J Bone Miner Res. 1994 Dec;9(12):1909-18. doi: 10.1002/jbmr.5650091210.
- Background Jiang C, Pitt RE, Bertram JE, Aneshansley DJ. Fractal-based image texture analysis of trabecular bone architecture. Med Biol Eng Comput. 1999 Jul;37(4):413-8. doi: 10.1007/BF02513322.
- Background Majumdar S, Weinstein RS, Prasad RR. Application of fractal geometry techniques to the study of trabecular bone. Med Phys. 1993 Nov-Dec;20(6):1611-9. doi: 10.1118/1.596948.
- Background Maragos, P., Fractal signal analysis using mathematicl morphology. Advances in Electronics and Electron Physics, 1994. 88: p. 199-246.
- Background Looker AC, Bauer DC, Chesnut CH 3rd, Gundberg CM, Hochberg MC, Klee G, Kleerekoper M, Watts NB, Bell NH. Clinical use of biochemical markers of bone remodeling: current status and future directions. Osteoporos Int. 2000;11(6):467-80. doi: 10.1007/s001980070088.
- Background Bauer DC, Sklarin PM, Stone KL, Black DM, Nevitt MC, Ensrud KE, Arnaud CD, Genant HK, Garnero P, Delmas PD, Lawaetz H, Cummings SR. Biochemical markers of bone turnover and prediction of hip bone loss in older women: the study of osteoporotic fractures. J Bone Miner Res. 1999 Aug;14(8):1404-10. doi: 10.1359/jbmr.1999.14.8.1404.
- Background Garnero P, Hausherr E, Chapuy MC, Marcelli C, Grandjean H, Muller C, Cormier C, Breart G, Meunier PJ, Delmas PD. Markers of bone resorption predict hip fracture in elderly women: the EPIDOS Prospective Study. J Bone Miner Res. 1996 Oct;11(10):1531-8. doi: 10.1002/jbmr.5650111021.
- Background van Daele PL, Seibel MJ, Burger H, Hofman A, Grobbee DE, van Leeuwen JP, Birkenhager JC, Pols HA. Case-control analysis of bone resorption markers, disability, and hip fracture risk: the Rotterdam study. BMJ. 1996 Feb 24;312(7029):482-3. doi: 10.1136/bmj.312.7029.482. No abstract available.
- Background Ravn P, Clemmesen B, Christiansen C. Biochemical markers can predict the response in bone mass during alendronate treatment in early postmenopausal women. Alendronate Osteoporosis Prevention Study Group. Bone. 1999 Mar;24(3):237-44. doi: 10.1016/s8756-3282(98)00183-5.
- Background Greenspan SL, Parker RA, Ferguson L, Rosen HN, Maitland-Ramsey L, Karpf DB. Early changes in biochemical markers of bone turnover predict the long-term response to alendronate therapy in representative elderly women: a randomized clinical trial. J Bone Miner Res. 1998 Sep;13(9):1431-8. doi: 10.1359/jbmr.1998.13.9.1431.
- Background Chesnut CH 3rd, Bell NH, Clark GS, Drinkwater BL, English SC, Johnson CC Jr, Notelovitz M, Rosen C, Cain DF, Flessland KA, Mallinak NJ. Hormone replacement therapy in postmenopausal women: urinary N-telopeptide of type I collagen monitors therapeutic effect and predicts response of bone mineral density. Am J Med. 1997 Jan;102(1):29-37. doi: 10.1016/s0002-9343(96)00387-7.
- Background Bjarnason NH, Bjarnason K, Hassager C, Christiansen C. The response in spinal bone mass to tibolone treatment is related to bone turnover in elderly women. Bone. 1997 Feb;20(2):151-5. doi: 10.1016/s8756-3282(96)00335-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alendronic Acid | Small molecule | 70 mg | — |