Abaloparatid før total knæarthroplastik
11. maj 2026 opdateret af: University of Wisconsin, Madison
Et åbent fase 2-studie af Abaloparatid til at mindske distalt femoral knogletab efter total knæarthroplastik
Efterforskeren antager, at behandling af osteoporotiske patienter med abaloparatid før og efter total knæarthroplastik vil reducere mængden af knogletab betydeligt.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Hos primære unilaterale totalknæarthroplastikpatienter vil investigator undersøge effekten af daglig abaloparatidbehandling hos kliniske osteoporotiske patienter, der begynder 3 måneder før operation og fortsætter i i alt 15 måneder.
Dette vil blive sammenlignet med osteopeniske patienter, der ikke modtager nogen behandling, samt tidligere offentliggjorte værdier hos ubehandlede osteoporotiske patienter 12 måneder efter total knæarthroplasty (TKA).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
58
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53705
- University of Wisconsin
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
55 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier
- Postmenopausale kvinder og mænd er ≥ 55 år og er planlagt til at gennemgå primær TKA ved University of Wisconsin Total Joint Program.
- Osteoporose, dvs. BMD T-score (ved hjælp af kvindelige referencedata) ≤ -2,5 ved lændehvirvelsøjlen, lårbenshalsen ELLER total hofte eller ≤ -1,1 med Vertebral Fracture Assessment bekræftet vertebral fraktur eller anamnese med nonvertebral fraktur med lavt trauma i de sidste 5 år ELLER osteopeni, BMD T-score (ved hjælp af kvindelige referencedata) -1,1 til -2,4 ved lændehvirvelsøjlen, lårbenshalsen eller total hofte og ingen tidligere brud med lavt trauma.
- Serum calcium (albumin-korrigeret), serum kreatinin og parathyroid (PTH) værdier alle inden for normalområdet og 25(OH)D > 10 ng/ml.
- Villig til at supplere med dagligt calcium og/eller D3-vitamin ved protokol specificerede doser.
- Kan give skriftligt informeret samtykke.
Eksklusionskriterier
- Uevaluerbar distal femur BMD på grund af hardware eller andre artefakter.
- Anamnese med knoglelidelser (f.eks. Pagets sygdom) bortset fra osteoporose.
- Anamnese med tidligere strålebehandling med ekstern stråle eller implantat, der involverer skelettet andet end radioaktivt jod.
- Anamnese med kroniske eller tilbagevendende nyre-, lever-, lunge-, allergiske, kardiovaskulære, gastrointestinale, endokrine, centralnervesystem, hæmatologiske eller metaboliske sygdomme eller immunologiske, følelsesmæssige og/eller psykiatriske forstyrrelser, som efter hovedforskerens mening ville kompromittere undersøgelsesdata gyldighed.
- Anamnese med Cushings sygdom, væksthormonmangel eller overskud, hyperthyroidisme, hypo- eller hyperparathyroidisme eller malabsorptive syndromer inden for det seneste år.
- Anamnese med signifikant nedsat nyrefunktion (serumkreatinin >2,0 mg/dL. Hvis serumkreatinin er > 1,5 og ≤ 2,0 mg/dL, skal den beregnede kreatininclearance (Cockcroft-Gault) være ≥ 37 ml/min.
- Anamnese med nefrolithiasis eller urolithiasis inden for de seneste fem år.
- Anamnese med kræft i de foregående 5 år (basalcelle- eller pladehudkræft er tilladt).
- Historie af osteosarkom til enhver tid.
- Patienter, der vides at være positive for hepatitis B, hepatitis C, HIV-1 eller HIV-2.
- Kendt overfølsomhed over for et hvilket som helst af testmaterialerne eller beslægtede forbindelser.
- Forudgående behandling med PTH- eller PTHrP-afledte lægemidler, (ABL, teriparatid eller PTH (1-84)).
- Forudgående behandling med intravenøse bisfosfonater til enhver tid eller orale bisfosfonater inden for de seneste tre år. Patienter, der havde modtaget et kort forløb med oral bisfosfonatbehandling (3 måneder eller mindre), kan tilmeldes, så længe behandlingen fandt sted 6 eller flere måneder før indskrivningen.
- Behandling med fluor eller strontium inden for de seneste fem år eller forudgående behandling med knoglevirkende forsøgsmidler til enhver tid.
- Behandling med calcitonin de seneste 6 måneder eller denosumab inden for de seneste 18 måneder.
- Behandling med antikonvulsiva, der påvirker vitamin D-metabolismen (phenobarbital, phenytoin, carbamazepin eller primidon) eller kronisk heparin inden for de foregående 6 måneder.
- Behandling med anabolske steroider eller calcineurinhæmmere (cyclosporin, tacrolimus)
- Daglig behandling med orale, intranasale eller inhalerede glukokortikoider inden for de foregående 12 måneder.
- Eksponering for ethvert forsøgslægemiddel inden for 12 måneder.
- Indtagelse af > 2 alkoholholdige drikkevarer om dagen eller brug af ulovlige stoffer inden for 12 måneder efter screening.
- Ikke egnet til undersøgelsesdeltagelse på grund af andre årsager efter efterforskernes skøn.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Behandlingsgruppe
Dem med klinisk osteoporose, der vælger ABL-behandling. ABL-terapi vil begynde 3 måneder før TKA og fortsætte i i alt 18 måneder. ABL vil blive administreret med en injektionspen med en dosis på 80 mcg SC qDay. |
18 måneders ABL-behandling
Andre navne:
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Ingen indgriben: Sammenligningsgruppe
Dem med klinisk osteopeni, som ikke modtager nogen behandling.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in Distal Femoral Bone Mineral Density (BMD) at the 25% Regions of Interest (ROIs)
Tidsramme: Baseline and approximately 18 months on study (15 months post-TKA)
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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.
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Baseline and approximately 18 months on study (15 months post-TKA)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Distal Femoral BMD at the 15% and 60% ROI
Tidsramme: Baseline and approximately 18 months on study (15 months post-TKA)
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Bone mineral density percent change at the 15% and 60% ROI of the surgical leg
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Baseline and approximately 18 months on study (15 months post-TKA)
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TBS Assessment by TRIP at the 15%, 25%, and 60% Femur ROIs
Tidsramme: 18 months on study (15 months post-TKA)
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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).
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18 months on study (15 months post-TKA)
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Knee Injury & Osteoarthritis Outcome Score (KOOS) JR
Tidsramme: 18 months on study (15 months post-TKA)
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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.
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18 months on study (15 months post-TKA)
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Change in Veterans RAND 12 (VR-12) Question Health Survey Score: Physical Health Component
Tidsramme: Baseline and approximately 18 months on study (15 months post-TKA)
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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.
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Baseline and approximately 18 months on study (15 months post-TKA)
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Change in Veterans RAND 12 (VR-12) Question Health Survey Score: Mental Health Component
Tidsramme: Baseline and approximately 18 months on study (15 months post-TKA)
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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.
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Baseline and approximately 18 months on study (15 months post-TKA)
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Forgotten Joint Survey(FJS) Score
Tidsramme: 18 months on study (15 months post-TKA)
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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)
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Change in Body Composition Using Bioelectrical Impedance Analysis of Lean Mass
Tidsramme: Baseline and approximately 18 months on study (15 months post-TKA)
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Change in total body composition using bioelectrical impedance analysis of lean mass.
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Baseline and approximately 18 months on study (15 months post-TKA)
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Change in Body Composition Using Bioelectrical Impedance Analysis of Fat Mass.
Tidsramme: Baseline and approximately 18 months on study (15 months post-TKA)
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Change in total body composition using bioelectrical impedance analysis of fat mass.
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Baseline and approximately 18 months on study (15 months post-TKA)
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TKA Complications: Number of Participants Needed Revision Surgery
Tidsramme: 18 months on study (15 months post-TKA)
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TKA complications: Number of participants needed revision surgery
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18 months on study (15 months post-TKA)
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TKA Complications: Number of Participants Had Fracture
Tidsramme: 18 months on study (15 months post-TKA)
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TKA complications: Number of participants had fracture
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18 months on study (15 months post-TKA)
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Precision Error on Knee Bone Density Measurement
Tidsramme: 18 months on study (15 months post-TKA)
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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).
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18 months on study (15 months post-TKA)
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Femur Cortical Thickness at the 15%, 25% and 60% Femur ROIs
Tidsramme: Baseline and approximately 18 months on study (15 months post-TKA)
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Cortical thickness change at the 15% and 60% ROI of the surgical leg
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Baseline and approximately 18 months on study (15 months post-TKA)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Neil Binkley, MD, University of Wisconsin, Madison
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Head J 2017 Periprosthetic distal femur fractures: Review of current treatment options. Reconstructive Review 7:NO4
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. januar 2020
Primær færdiggørelse (Faktiske)
3. april 2025
Studieafslutning (Faktiske)
3. april 2025
Datoer for studieregistrering
Først indsendt
29. oktober 2019
Først indsendt, der opfyldte QC-kriterier
15. november 2019
Først opslået (Faktiske)
18. november 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2019-0685
- A534255 (Anden identifikator: UW- Madison)
- SMPH/MEDICINE/MEDICINE*G (Anden identifikator: UW Madison)
- Protocol Version 3/22/2021 (Anden identifikator: UW Madison)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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