OsteoporosisPhase 4NCT04167163
Abaloparatide Before Total Knee Arthroplasty
A Phase 4 study testing Abaloparatide in people with Osteoporosis and Arthroplasties, Knee Replacement, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The investigator hypothesizes that treating osteoporotic patients with abaloparatide prior to and after total knee arthroplasty will significantly reduce the amount of bone loss. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Osteoporosis, Arthroplasties, Knee Replacement
- What is being tested?
- Abaloparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to 3 Apr 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal women and men age ge ≥ 55 years and scheduled to undergo primary TKA at the University of Wisconsin Total Joint Program.
- Osteoporosis, i.e., BMD T-score (using female reference data) ≤ -2.5 at the lumbar spine, femoral neck OR total hip or ≤ -1.1 with Vertebral Fracture Assessment confirmed vertebral fracture or history of low-trauma nonvertebral fracture in the past 5 years OR osteopenia, BMD T-score (using female reference data) -1.1 to -2.4 at the lumbar spine, femoral neck or total hip and no prior low-trauma fracture.
- Serum calcium (albumin-corrected), serum creatinine and Parathyroid(PTH) values all within the normal range and 25(OH)D > 10 ng/mL.
- Willing to supplement with daily calcium and/or vitamin D3 at protocol specified doses.
- Able to provide written informed consent.
Who cannot join
- Unevaluable distal femur BMD due to hardware or other artifacts.
- History of bone disorders (e.g., Paget's disease) other than osteoporosis.
- History of prior external beam or implant radiation therapy involving the skeleton other than radioiodine.
- History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances that, in opinion of the principal investigator, would compromise study data validity.
- History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism, hypo- or hyperparathyroidism or malabsorptive syndromes within the past year.
- History of significantly impaired renal function (serum creatinine >2.0 mg/dL. If the serum creatinine is > 1.5 and ≤ 2.0 mg/dL, the calculated creatinine clearance (Cockcroft-Gault) must be ≥ 37 mL/min.
Show all 21Show fewer
- History of nephrolithiasis or urolithiasis within the past five years.
- History of cancer in prior 5 years (basal cell or squamous skin cancer is permissible).
- History of osteosarcoma at any time.
- Patients known to be positive for Hepatitis B, Hepatitis C, HIV-1 or HIV-2.
- Known hypersensitivity to any of the test materials or related compounds.
- Prior treatment with PTH- or PTHrP-derived drugs, (ABL, teriparatide or PTH (1-84)).
- Prior treatment with intravenous bisphosphonates at any time or oral bisphosphonates within the past three years. Patients who had received a short course of oral bisphosphonate therapy (3 months or less) may be enrolled as long as the treatment occurred 6 or more months prior to enrollment.
- Treatment with fluoride or strontium in the past five years or prior treatment with bone-acting investigational agents at any time.
- Treatment with calcitonin the past 6 months or denosumab in the past 18 months.
- Treatment with anticonvulsants affecting vitamin D metabolism (phenobarbital, phenytoin, carbamazepine or primidone) or chronic heparin within the prior 6 months.
- Treatment with anabolic steroids or calcineurin inhibitors (cyclosporin, tacrolimus)
- Daily treatment with oral, intranasal or inhaled glucocorticoids in the prior 12 months.
- Exposure to any investigational drug within 12 months.
- Consumption of > 2 alcoholic drinks per day or use of illegal drugs within 12 months of screening.
- Not suitable for study participation due to other reasons at the investigators discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Phase 2 Study of Abaloparatide to Mitigate Distal Femoral Bone Loss Following Total Knee Arthroplasty
The investigator hypothesizes that treating osteoporotic patients with abaloparatide prior to and after total knee arthroplasty will significantly reduce the amount of bone loss.
Read the detailed description
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).
- Conditions
- Osteoporosis, Arthroplasties, Knee Replacement
- Being tested
- Abaloparatide
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbaloparatideDrug
Also called Tymlos
18 month ABL treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Abaloparatide |
| Comparator group | No intervention | Those with clinical osteopenia who receive no treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and approximately 18 months on study (15 months post-TKA)
Secondary outcomes (11)
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
Measured: Baseline and approximately 18 months on study (15 months post-TKA)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 18 months on study (15 months post-TKA)
TKA Complications: Number of Participants Had Fracture
TKA complications: Number of participants had fracture
Measured: 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).
Measured: 18 months on study (15 months post-TKA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start10 Jan 2020
- Primary completion3 Apr 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Radius Health, Inc.
- Responsible party
- Sponsor
- Investigators
- Neil Binkley, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167163
- Sponsor's protocol ID
- 2019-0685
- Other IDs
- A534255, SMPH/MEDICINE/MEDICINE*G, Protocol Version 3/22/2021
- Status last verified
- May 2026
- First submitted
- 29 Oct 2019
- Last updated
- 5 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26333733Kurtz 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.
PubMed 17403800Chang 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.
PubMed 25368498Lingard 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.
PubMed 20032523Frenzel 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.
PubMed 26330085Sarmah 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.
PubMed 22943223Della 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.
PubMed 21566478Head 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.
PubMed 21196551Hoffmann 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.
PubMed 22348954Reeves 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.
PubMed 29066112Lizaur-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.
PubMed 23602235Ruder 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.
PubMed 28131543Gazdzik 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.
PubMed 18619880Windisch 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.
PubMed 22886240
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 2 Study of Abaloparatide to Mitigate Distal Femoral Bone Loss Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04167163
- Acronym / sponsor ID
- 2019-0685
- Conditions
- Osteoporosis, Arthroplasties, Knee Replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Radius Health, Inc.
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Posted 5 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator hypothesizes that treating osteoporotic patients with abaloparatide prior to and after total knee arthroplasty will significantly reduce the amount of bone loss.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Drug: AbaloparatideThose 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Post-menopausal women and men age ge ≥ 55 years and scheduled to undergo primary TKA at the University of Wisconsin Total Joint Program.
- Osteoporosis, i.e., BMD T-score (using female reference data) ≤ -2.5 at the lumbar spine, femoral neck OR total hip or ≤ -1.1 with Vertebral Fracture Assessment confirmed vertebral fracture or history of low-trauma nonvertebral fracture in the past 5 years OR osteopenia, BMD T-score (using female reference data) -1.1 to -2.4 at the lumbar spine, femoral neck or total hip and no prior low-trauma fracture.
- Serum calcium (albumin-corrected), serum creatinine and Parathyroid(PTH) values all within the normal range and 25(OH)D > 10 ng/mL.
- Willing to supplement with daily calcium and/or vitamin D3 at protocol specified doses.
- Able to provide written informed consent.
Key exclusion criteria (21 listed)
- Unevaluable distal femur BMD due to hardware or other artifacts.
- History of bone disorders (e.g., Paget's disease) other than osteoporosis.
- History of prior external beam or implant radiation therapy involving the skeleton other than radioiodine.
- History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances that, in opinion of the principal investigator, would compromise study data validity.
- History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism, hypo- or hyperparathyroidism or malabsorptive syndromes within the past year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbaloparatideAlso: Tymlos18 month ABL treatment | Drug | Treatment group |
Primary outcome
Change in Distal Femoral Bone Mineral Density (BMD) at the 25% Regions of Interest (ROIs)
Time frame: Baseline and approximately 18 months on study (15 months post-TKA)
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.
11 secondary outcomes
Change in Distal Femoral BMD at the 15% and 60% ROI
Time frame: Baseline and approximately 18 months on study (15 months post-TKA)
TBS Assessment by TRIP at the 15%, 25%, and 60% Femur ROIs
Time frame: 18 months on study (15 months post-TKA)
Knee Injury & Osteoarthritis Outcome Score (KOOS) JR
Time frame: 18 months on study (15 months post-TKA)
Change in Veterans RAND 12 (VR-12) Question Health Survey Score: Physical Health Component
Time frame: 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
Time frame: Baseline and approximately 18 months on study (15 months post-TKA)
Forgotten Joint Survey(FJS) Score
Time frame: 18 months on study (15 months post-TKA)
Change in Body Composition Using Bioelectrical Impedance Analysis of Lean Mass
Time frame: Baseline and approximately 18 months on study (15 months post-TKA)
Change in Body Composition Using Bioelectrical Impedance Analysis of Fat Mass.
Time frame: Baseline and approximately 18 months on study (15 months post-TKA)
TKA Complications: Number of Participants Needed Revision Surgery
Time frame: 18 months on study (15 months post-TKA)
TKA Complications: Number of Participants Had Fracture
Time frame: 18 months on study (15 months post-TKA)
Precision Error on Knee Bone Density Measurement
Time frame: 18 months on study (15 months post-TKA)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26333733Maradit 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.
- Background: PubMed 17403800Kurtz 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.
- Background: PubMed 25368498Chang 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.
- Background: PubMed 20032523Lingard 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.
- Background: PubMed 26330085Frenzel 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.
- Background: PubMed 22943223Sarmah 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.
- Background: PubMed 21566478Della 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.
- BackgroundHead J 2017 Periprosthetic distal femur fractures: Review of current treatment options. Reconstructive Review 7:NO4
- Background: PubMed 21196551Meek 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.
- Background: PubMed 22348954Hoffmann 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.
- Background: PubMed 29066112Reeves 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.
- Background: PubMed 23602235Lizaur-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Binkley, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abaloparatide in people with Osteoporosis and Arthroplasties, Knee Replacement, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Distal Femoral Bone Mineral Density (BMD) at the 25% Regions of Interest (ROIs) (time frame: Baseline and approximately 18 months on study (15 months post-TKA)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04167163, which also lists 44 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.