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| ID | Type | Description | Link |
|---|---|---|---|
| A534255 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/MEDICINE*G | Other Identifier | UW Madison | |
| Protocol Version 3/22/2021 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Radius Health, Inc. | INDUSTRY |
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The investigator hypothesizes that treating osteoporotic patients with abaloparatide prior to and after total knee arthroplasty will significantly reduce the amount of bone loss.
In primary unilateral total knee arthroplasty patients, The investigator will examine the effect of daily abaloparatide therapy in clinical osteoporotic patients beginning 3 months pre-op and continued for a total of 15 months. This will be compared to osteopenic patients receiving no therapy as well as previously published values in untreated osteoporotic patients 12 months following Total Knee Arthroplasty (TKA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Active Comparator | Those with clinical osteoporosis who elect ABL treatment. ABL therapy will begin 3 months pre-TKA and continue for a total of 18 months. ABL will be administered by injection pen with dose of 80 mcg SC qDay. |
|
| Comparator group | No Intervention | Those with clinical osteopenia who receive no treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abaloparatide | Drug | 18 month ABL treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Distal Femoral Bone Mineral Density (BMD) at the 25% Regions of Interest (ROIs) | Bone mineral density change at the 25% ROI of the surgical leg. Dual-energy X-ray absorptiometry (DXA) measured BMD was obtained at a point (ROI) 25% the length of the total surgical femur. Percent change at 25% ROI was calculated from baseline to 18 months. | Baseline and approximately 18 months on study (15 months post-TKA) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Distal Femoral BMD at the 15% and 60% ROI | Bone mineral density percent change at the 15% and 60% ROI of the surgical leg | Baseline and approximately 18 months on study (15 months post-TKA) |
| TBS Assessment by TRIP at the 15%, 25%, and 60% Femur ROIs |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Femur Cortical Thickness at the 15%, 25% and 60% Femur ROIs | Cortical thickness change at the 15% and 60% ROI of the surgical leg | Baseline and approximately 18 months on study (15 months post-TKA) |
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Neil Binkley, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26333733 | Background | Maradit Kremers H, Larson DR, Crowson CS, Kremers WK, Washington RE, Steiner CA, Jiranek WA, Berry DJ. Prevalence of Total Hip and Knee Replacement in the United States. J Bone Joint Surg Am. 2015 Sep 2;97(17):1386-97. doi: 10.2106/JBJS.N.01141. | |
| 17403800 | Background | Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222. |
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Participants were recruited from the UW Total Joint Program at the American Center and enrolled from January 2020 to August 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | Those with clinical osteoporosis who elect ABL treatment. ABL therapy will begin 3 months pre-TKA and continue for a total of 18 months. ABL will be administered by injection pen with dose of 80 mcg SC qDay. Abaloparatide: 18 month ABL treatment |
| FG001 | Comparator Group | Those with clinical osteopenia who receive no treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Those with clinical osteoporosis who elect ABL treatment. ABL therapy will begin 3 months pre-TKA and continue for a total of 18 months. ABL will be administered by injection pen with dose of 80 mcg SC qDay. Abaloparatide: 18 month ABL treatment |
| BG001 | Comparator Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Distal Femoral Bone Mineral Density (BMD) at the 25% Regions of Interest (ROIs) | Bone mineral density change at the 25% ROI of the surgical leg. Dual-energy X-ray absorptiometry (DXA) measured BMD was obtained at a point (ROI) 25% the length of the total surgical femur. Percent change at 25% ROI was calculated from baseline to 18 months. | Posted | Mean | Standard Error | percent change | Baseline and approximately 18 months on study (15 months post-TKA) |
|
up to 18 months on study
Participants questioned regarding adverse events, falls and fractures at treatment follow up, pre-TKA study visit, 6 month follow up for TKA, and 15 month follow up (up to 18 months on study)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | Those with clinical osteoporosis who elect ABL treatment. ABL therapy will begin 3 months pre-TKA and continue for a total of 18 months. ABL will be administered by injection pen with dose of 80 mcg SC qDay. Abaloparatide: 18 month ABL treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lightheadedness | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Neil Binkley | University of Wisconsin - Madison | 608-265-6410 | uwocrp@aging.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2021 | Jan 21, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C000596789 | abaloparatide |
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Trabecular bone score (TBS) assessment by Texture Research Investigation (Platform (TRIP) software change at the 15% and 25% femur ROIs (TBS >1.350 is normal; TBS between 1.200 and 1.350 is indicative of partially degraded microarchitecture; and TBS <1.200 equals degraded microarchitecture). |
| 18 months on study (15 months post-TKA) |
| Knee Injury & Osteoarthritis Outcome Score (KOOS) JR | Patient reported knee function score. The KOOS, JR was developed from the original long version of the Knee injury and Osteoarthritis Outcome Score (KOOS) survey using Rasch analysis. The KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score (0-100). The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health. | 18 months on study (15 months post-TKA) |
| Change in Veterans RAND 12 (VR-12) Question Health Survey Score: Physical Health Component | 12 Item Health Survey using patient's self assessment of their perspective of their health and ability to do daily functions. Scores are derived using an algorithm that is referenced to a metric centered at 50.0 where a zero score indicates the lowest level of health and 100 indicates the highest level of health. | Baseline and approximately 18 months on study (15 months post-TKA) |
| Change in Veterans RAND 12 (VR-12) Question Health Survey Score: Mental Health Component | 12 Item Health Survey using patient's self assessment of their perspective of their health and ability to do daily functions. Scores are derived using an algorithm that is referenced to a metric centered at 50.0 where a zero score indicates the lowest level of health and 100 indicates the highest level of health. | Baseline and approximately 18 months on study (15 months post-TKA) |
| Forgotten Joint Survey(FJS) Score | FJS-12 consists of 12 questions and is scored using a 5-point response format with the raw scores transformed onto a 0- to 100-point scale. High scores indicate good outcome, that is, a high degree of forgetting the joint in everyday life (forgotten joint phenomenon). | 18 months on study (15 months post-TKA) |
| Change in Body Composition Using Bioelectrical Impedance Analysis of Lean Mass | Change in total body composition using bioelectrical impedance analysis of lean mass. | Baseline and approximately 18 months on study (15 months post-TKA) |
| Change in Body Composition Using Bioelectrical Impedance Analysis of Fat Mass. | Change in total body composition using bioelectrical impedance analysis of fat mass. | Baseline and approximately 18 months on study (15 months post-TKA) |
| TKA Complications: Number of Participants Needed Revision Surgery | TKA complications: Number of participants needed revision surgery | 18 months on study (15 months post-TKA) |
| TKA Complications: Number of Participants Had Fracture | TKA complications: Number of participants had fracture | 18 months on study (15 months post-TKA) |
| Precision Error on Knee Bone Density Measurement | Precision assessment in the field of bone densitometry is the process whereby the ability of the instrument and the technologist to reproduce similar results, given no real biologic change, is tested. To achieve statistical power, the investigators will take duplicate knee bone density measurements on 30 participants at either their 6 month or 15 month visit. The standard deviation for each participant is calculated, then the root mean square standard deviation for the group is calculated. The mathematical result of precision assessment is displayed as percent coefficient of variation (CV). | 18 months on study (15 months post-TKA) |
| 25368498 | Background | Chang CB, Kim TK, Kang YG, Seong SC, Kang SB. Prevalence of osteoporosis in female patients with advanced knee osteoarthritis undergoing total knee arthroplasty. J Korean Med Sci. 2014 Oct;29(10):1425-31. doi: 10.3346/jkms.2014.29.10.1425. Epub 2014 Oct 8. |
| 20032523 | Background | Lingard EA, Mitchell SY, Francis RM, Rawlings D, Peaston R, Birrell FN, McCaskie AW. The prevalence of osteoporosis in patients with severe hip and knee osteoarthritis awaiting joint arthroplasty. Age Ageing. 2010 Mar;39(2):234-9. doi: 10.1093/ageing/afp222. Epub 2009 Dec 23. |
| 26330085 | Background | Frenzel S, Vecsei V, Negrin L. Periprosthetic femoral fractures--incidence, classification problems and the proposal of a modified classification scheme. Int Orthop. 2015 Oct;39(10):1909-20. doi: 10.1007/s00264-015-2967-4. Epub 2015 Sep 2. |
| 22943223 | Background | Sarmah SS, Patel S, Reading G, El-Husseiny M, Douglas S, Haddad FS. Periprosthetic fractures around total knee arthroplasty. Ann R Coll Surg Engl. 2012 Jul;94(5):302-7. doi: 10.1308/003588412X13171221592537. |
| 21566478 | Background | Della Rocca GJ, Leung KS, Pape HC. Periprosthetic fractures: epidemiology and future projections. J Orthop Trauma. 2011 Jun;25 Suppl 2:S66-70. doi: 10.1097/BOT.0b013e31821b8c28. |
| Background | Head J 2017 Periprosthetic distal femur fractures: Review of current treatment options. Reconstructive Review 7:NO4 |
| 21196551 | Background | Meek RM, Norwood T, Smith R, Brenkel IJ, Howie CR. The risk of peri-prosthetic fracture after primary and revision total hip and knee replacement. J Bone Joint Surg Br. 2011 Jan;93(1):96-101. doi: 10.1302/0301-620X.93B1.25087. |
| 22348954 | Background | Hoffmann MF, Jones CB, Sietsema DL, Koenig SJ, Tornetta P 3rd. Outcome of periprosthetic distal femoral fractures following knee arthroplasty. Injury. 2012 Jul;43(7):1084-9. doi: 10.1016/j.injury.2012.01.025. Epub 2012 Feb 18. |
| 29066112 | Background | Reeves RA, Schairer WW, Jevsevar DS. Costs and Risk Factors for Hospital Readmission After Periprosthetic Knee Fractures in the United States. J Arthroplasty. 2018 Feb;33(2):324-330.e1. doi: 10.1016/j.arth.2017.09.024. Epub 2017 Sep 23. |
| 23602235 | Background | Lizaur-Utrilla A, Miralles-Munoz FA, Sanz-Reig J. Functional outcome of total knee arthroplasty after periprosthetic distal femoral fracture. J Arthroplasty. 2013 Oct;28(9):1585-8. doi: 10.1016/j.arth.2013.03.007. Epub 2013 Apr 17. |
| 28131543 | Background | Ruder JA, Hart GP, Kneisl JS, Springer BD, Karunakar MA. Predictors of Functional Recovery Following Periprosthetic Distal Femur Fractures. J Arthroplasty. 2017 May;32(5):1571-1575. doi: 10.1016/j.arth.2016.12.013. Epub 2016 Dec 23. |
| 18619880 | Background | Gazdzik TS, Gajda T, Kaleta M. Bone mineral density changes after total knee arthroplasty: one-year follow-up. J Clin Densitom. 2008 Jul-Sep;11(3):345-50. doi: 10.1016/j.jocd.2008.04.007. Epub 2008 Jul 10. |
| 22886240 | Background | Windisch C, Windisch B, Kolb W, Kolb K, Grutzner P, Roth A. Osteodensitometry measurements of periprosthetic bone using dual energy X-ray absorptiometry following total knee arthroplasty. Arch Orthop Trauma Surg. 2012 Nov;132(11):1595-601. doi: 10.1007/s00402-012-1601-9. Epub 2012 Aug 12. |
| 15261216 | Background | Soininvaara TA, Miettinen HJ, Jurvelin JS, Suomalainen OT, Alhava EM, Kroger HP. Periprosthetic femoral bone loss after total knee arthroplasty: 1-year follow-up study of 69 patients. Knee. 2004 Aug;11(4):297-302. doi: 10.1016/j.knee.2003.09.006. |
| 20513875 | Background | Minoda Y, Ikebuchi M, Kobayashi A, Iwaki H, Inori F, Nakamura H. A cemented mobile-bearing total knee replacement prevents periprosthetic loss of bone mineral density around the femoral component: a matched cohort study. J Bone Joint Surg Br. 2010 Jun;92(6):794-8. doi: 10.1302/0301-620X.92B6.23159. |
| 27120266 | Background | Jaroma A, Soininvaara T, Kroger H. Periprosthetic tibial bone mineral density changes after total knee arthroplasty. Acta Orthop. 2016 Jun;87(3):268-73. doi: 10.3109/17453674.2016.1173982. Epub 2016 Apr 27. |
| 16846605 | Background | Au AG, James Raso V, Liggins AB, Amirfazli A. Contribution of loading conditions and material properties to stress shielding near the tibial component of total knee replacements. J Biomech. 2007;40(6):1410-6. doi: 10.1016/j.jbiomech.2006.05.020. Epub 2006 Jul 17. |
| 26849808 | Background | Moon YW, Kim HJ, Ahn HS, Lee DH. Serial Changes of Quadriceps and Hamstring Muscle Strength Following Total Knee Arthroplasty: A Meta-Analysis. PLoS One. 2016 Feb 5;11(2):e0148193. doi: 10.1371/journal.pone.0148193. eCollection 2016. |
| 12919862 | Background | Stevens JE, Mizner RL, Snyder-Mackler L. Quadriceps strength and volitional activation before and after total knee arthroplasty for osteoarthritis. J Orthop Res. 2003 Sep;21(5):775-9. doi: 10.1016/S0736-0266(03)00052-4. |
| 30228047 | Background | Thomas B, Binkley N, Anderson PA, Krueger D. DXA Measured Distal Femur Bone Mineral Density in Patients After Total Knee Arthroplasty: Method Development and Reproducibility. J Clin Densitom. 2019 Jan-Mar;22(1):67-73. doi: 10.1016/j.jocd.2018.08.003. Epub 2018 Aug 13. |
| 30171301 | Background | Blaty T, Krueger D, Illgen R, Squire M, Heiderscheit B, Binkley N, Anderson P. DXA evaluation of femoral bone mineral density and cortical width in patients with prior total knee arthroplasty. Osteoporos Int. 2019 Feb;30(2):383-390. doi: 10.1007/s00198-018-4682-7. Epub 2018 Aug 31. |
| 10954783 | Background | Soininvaara T, Kroger H, Jurvelin JS, Miettinen H, Suomalainen O, Alhava E. Measurement of bone density around total knee arthroplasty using fan-beam dual energy X-ray absorptiometry. Calcif Tissue Int. 2000 Sep;67(3):267-72. doi: 10.1007/s002230001111. |
| 25737517 | Background | Jaroma AV, Soininvaara TA, Kroger H. Effect of one-year post-operative alendronate treatment on periprosthetic bone after total knee arthroplasty. A seven-year randomised controlled trial of 26 patients. Bone Joint J. 2015 Mar;97-B(3):337-45. doi: 10.1302/0301-620X.97B3.33643. |
| 28869116 | Background | Suzuki T, Sukezaki F, Shibuki T, Toyoshima Y, Nagai T, Inagaki K. Teriparatide Administration Increases Periprosthetic Bone Mineral Density After Total Knee Arthroplasty: A Prospective Study. J Arthroplasty. 2018 Jan;33(1):79-85. doi: 10.1016/j.arth.2017.07.026. Epub 2017 Jul 25. |
| 27122506 | Background | Kaneko T, Otani T, Kono N, Mochizuki Y, Mori T, Nango N, Ikegami H, Musha Y. Weekly injection of teriparatide for bone ingrowth after cementless total knee arthroplasty. J Orthop Surg (Hong Kong). 2016 Apr;24(1):16-21. doi: 10.1177/230949901602400106. |
| 26260784 | Background | Kobayashi N, Inaba Y, Uchiyama M, Ike H, Kubota S, Saito T. Teriparatide Versus Alendronate for the Preservation of Bone Mineral Density After Total Hip Arthroplasty - A randomized Controlled Trial. J Arthroplasty. 2016 Jan;31(1):333-8. doi: 10.1016/j.arth.2015.07.017. Epub 2015 Jul 17. |
| 26444555 | Background | Teng S, Yi C, Krettek C, Jagodzinski M. Bisphosphonate Use and Risk of Implant Revision after Total Hip/Knee Arthroplasty: A Meta-Analysis of Observational Studies. PLoS One. 2015 Oct 7;10(10):e0139927. doi: 10.1371/journal.pone.0139927. eCollection 2015. |
| 23304137 | Background | Smee DJ, Anson JM, Waddington GS, Berry HL. Association between Physical Functionality and Falls Risk in Community-Living Older Adults. Curr Gerontol Geriatr Res. 2012;2012:864516. doi: 10.1155/2012/864516. Epub 2012 Dec 4. |
| 23903951 | Background | Binkley N, Krueger D, Buehring B. What's in a name revisited: should osteoporosis and sarcopenia be considered components of "dysmobility syndrome?". Osteoporos Int. 2013 Dec;24(12):2955-9. doi: 10.1007/s00198-013-2427-1. Epub 2013 Aug 1. |
| 29701911 | Background | Buehring B, Hansen KE, Lewis BL, Cummings SR, Lane NE, Binkley N, Ensrud KE, Cawthon PM; Osteoporotic Fractures in Men (MrOS) Study Research Group. Dysmobility Syndrome Independently Increases Fracture Risk in the Osteoporotic Fractures in Men (MrOS) Prospective Cohort Study. J Bone Miner Res. 2018 Sep;33(9):1622-1629. doi: 10.1002/jbmr.3455. Epub 2018 Jun 21. |
| 18448878 | Background | Meier W, Mizner RL, Marcus RL, Dibble LE, Peters C, Lastayo PC. Total knee arthroplasty: muscle impairments, functional limitations, and recommended rehabilitation approaches. J Orthop Sports Phys Ther. 2008 May;38(5):246-56. doi: 10.2519/jospt.2008.2715. Epub 2007 Dec 14. |
| 19713269 | Background | Valtonen A, Poyhonen T, Heinonen A, Sipila S. Muscle deficits persist after unilateral knee replacement and have implications for rehabilitation. Phys Ther. 2009 Oct;89(10):1072-9. doi: 10.2522/ptj.20070295. Epub 2009 Aug 27. |
| 15866968 | Background | Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992. |
| 20133393 | Background | Yamada Y, Schoeller DA, Nakamura E, Morimoto T, Kimura M, Oda S. Extracellular water may mask actual muscle atrophy during aging. J Gerontol A Biol Sci Med Sci. 2010 May;65(5):510-6. doi: 10.1093/gerona/glq001. Epub 2010 Feb 4. |
| 29198074 | Background | Buehring B, Siglinsky E, Krueger D, Evans W, Hellerstein M, Yamada Y, Binkley N. Comparison of muscle/lean mass measurement methods: correlation with functional and biochemical testing. Osteoporos Int. 2018 Mar;29(3):675-683. doi: 10.1007/s00198-017-4315-6. Epub 2017 Dec 2. |
| 29627891 | Background | Liu Y, Levack AE, Marty E, Or O, Samuels BP, Redko M, Lane JM. Anabolic agents: what is beyond osteoporosis? Osteoporos Int. 2018 May;29(5):1009-1022. doi: 10.1007/s00198-018-4507-8. Epub 2018 Apr 7. |
| 30798359 | Background | Prince JM, Bernatz JT, Binkley N, Abdel MP, Anderson PA. Changes in femoral bone mineral density after total knee arthroplasty: a systematic review and meta-analysis. Arch Osteoporos. 2019 Feb 23;14(1):23. doi: 10.1007/s11657-019-0572-7. |
| 30992237 | Background | Bernatz JT, Brooks AE, Squire MW, Illgen RI 2nd, Binkley NC, Anderson PA. Osteoporosis Is Common and Undertreated Prior to Total Joint Arthroplasty. J Arthroplasty. 2019 Jul;34(7):1347-1353. doi: 10.1016/j.arth.2019.03.044. Epub 2019 Mar 28. |
| 31227302 | Background | Bernatz JT, Krueger DC, Squire MW, Illgen RL 2nd, Binkley NC, Anderson PA. Unrecognized Osteoporosis Is Common in Patients With a Well-Functioning Total Knee Arthroplasty. J Arthroplasty. 2019 Oct;34(10):2347-2350. doi: 10.1016/j.arth.2019.05.041. Epub 2019 May 30. |
| 19533166 | Background | Yamada Y, Masuo Y, Yokoyama K, Hashii Y, Ando S, Okayama Y, Morimoto T, Kimura M, Oda S. Proximal electrode placement improves the estimation of body composition in obese and lean elderly during segmental bioelectrical impedance analysis. Eur J Appl Physiol. 2009 Sep;107(2):135-44. doi: 10.1007/s00421-009-1106-6. Epub 2009 Jun 17. |
| 27533157 | Background | Miller PD, Hattersley G, Riis BJ, Williams GC, Lau E, Russo LA, Alexandersen P, Zerbini CA, Hu MY, Harris AG, Fitzpatrick LA, Cosman F, Christiansen C; ACTIVE Study Investigators. Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial. JAMA. 2016 Aug 16;316(7):722-33. doi: 10.1001/jama.2016.11136. |
Those with clinical osteopenia who receive no treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Those with clinical osteopenia who receive no treatment. |
|
|
| Secondary | Change in Distal Femoral BMD at the 15% and 60% ROI | Bone mineral density percent change at the 15% and 60% ROI of the surgical leg | In concurrent projects, 60% femur ROI did not show clinical association. Given the time to manually collect these data, the investigator decided not to test this objective in the current study, therefore this data was not collected from any participants. | Posted | Mean | Standard Error | percent change | Baseline and approximately 18 months on study (15 months post-TKA) |
|
|
|
| Secondary | TBS Assessment by TRIP at the 15%, 25%, and 60% Femur ROIs | Trabecular bone score (TBS) assessment by Texture Research Investigation (Platform (TRIP) software change at the 15% and 25% femur ROIs (TBS >1.350 is normal; TBS between 1.200 and 1.350 is indicative of partially degraded microarchitecture; and TBS <1.200 equals degraded microarchitecture). | In concurrent projects, 60% femur ROI did not show clinical association. Given the time to manually collect these data, the investigator decided not to test this objective in the current study, therefore this data was not collected from any participants. | Posted | Mean | Standard Deviation | score | 18 months on study (15 months post-TKA) |
|
|
|
| Secondary | Knee Injury & Osteoarthritis Outcome Score (KOOS) JR | Patient reported knee function score. The KOOS, JR was developed from the original long version of the Knee injury and Osteoarthritis Outcome Score (KOOS) survey using Rasch analysis. The KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score (0-100). The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health. | Not all participants completed or returned the surveys. | Posted | Mean | Standard Deviation | score on a scale | 18 months on study (15 months post-TKA) |
|
|
|
| Secondary | Change in Veterans RAND 12 (VR-12) Question Health Survey Score: Physical Health Component | 12 Item Health Survey using patient's self assessment of their perspective of their health and ability to do daily functions. Scores are derived using an algorithm that is referenced to a metric centered at 50.0 where a zero score indicates the lowest level of health and 100 indicates the highest level of health. | Not all participants completed or returned the surveys. | Posted | Mean | Standard Deviation | score on a scale | Baseline and approximately 18 months on study (15 months post-TKA) |
|
|
|
| Secondary | Change in Veterans RAND 12 (VR-12) Question Health Survey Score: Mental Health Component | 12 Item Health Survey using patient's self assessment of their perspective of their health and ability to do daily functions. Scores are derived using an algorithm that is referenced to a metric centered at 50.0 where a zero score indicates the lowest level of health and 100 indicates the highest level of health. | Not all participants completed or returned the surveys. | Posted | Mean | Standard Deviation | score on a scale | Baseline and approximately 18 months on study (15 months post-TKA) |
|
|
|
| Secondary | Forgotten Joint Survey(FJS) Score | FJS-12 consists of 12 questions and is scored using a 5-point response format with the raw scores transformed onto a 0- to 100-point scale. High scores indicate good outcome, that is, a high degree of forgetting the joint in everyday life (forgotten joint phenomenon). | Some participants did not complete assessment at 18 month time point. | Posted | Mean | Standard Deviation | score on a scale | 18 months on study (15 months post-TKA) |
|
|
|
| Secondary | Change in Body Composition Using Bioelectrical Impedance Analysis of Lean Mass | Change in total body composition using bioelectrical impedance analysis of lean mass. | Posted | Mean | Standard Deviation | grams | Baseline and approximately 18 months on study (15 months post-TKA) |
|
|
|
| Secondary | Change in Body Composition Using Bioelectrical Impedance Analysis of Fat Mass. | Change in total body composition using bioelectrical impedance analysis of fat mass. | Posted | Mean | Standard Deviation | grams | Baseline and approximately 18 months on study (15 months post-TKA) |
|
|
|
| Secondary | TKA Complications: Number of Participants Needed Revision Surgery | TKA complications: Number of participants needed revision surgery | Posted | Count of Participants | Participants | 18 months on study (15 months post-TKA) |
|
|
|
| Secondary | TKA Complications: Number of Participants Had Fracture | TKA complications: Number of participants had fracture | Posted | Count of Participants | Participants | 18 months on study (15 months post-TKA) |
|
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| Secondary | Precision Error on Knee Bone Density Measurement | Precision assessment in the field of bone densitometry is the process whereby the ability of the instrument and the technologist to reproduce similar results, given no real biologic change, is tested. To achieve statistical power, the investigators will take duplicate knee bone density measurements on 30 participants at either their 6 month or 15 month visit. The standard deviation for each participant is calculated, then the root mean square standard deviation for the group is calculated. The mathematical result of precision assessment is displayed as percent coefficient of variation (CV). | Posted | Number | percent coefficient of variation (CV) | 18 months on study (15 months post-TKA) |
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| Other Pre-specified | Change in Femur Cortical Thickness at the 15%, 25% and 60% Femur ROIs | Cortical thickness change at the 15% and 60% ROI of the surgical leg | Not Posted | Baseline and approximately 18 months on study (15 months post-TKA) | Participants |
| 0 |
| 29 |
| 3 |
| 29 |
| 8 |
| 29 |
| EG001 | Comparator Group | Those with clinical osteopenia who receive no treatment. | 0 | 29 | 1 | 29 | 1 | 29 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Chest Pain | General disorders | Systematic Assessment |
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| Motor Vehicle Accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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Not provided
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| 60 percent ROI |
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| 18 months (15% femur ROI) |
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| baseline (25% femur ROI) |
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| 18 months (25% femur ROI) |
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| baseline (60% femur ROI) |
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| 18 months (60% femur ROI) |
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| 18 months on study |
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