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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Abaloparatide Before Total Knee Arthroplasty

NCTNCT04167163 (opens ClinicalTrials.gov in a new tab)Other id2019-0685Other idA534255Other idSMPH/MEDICINE/MEDICINE*GOther idProtocol Version 3/22/2021

Overview

Status
Completed
Phase
Phase 4
Enrollment
58 participants (actual)
Sponsor
University of Wisconsin, Madison · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
10 Jan 2020
Primary completion
3 Apr 2025
Completion
3 Apr 2025
First posted
18 Nov 2019
Last update posted
5 Jun 2026
Conditions
Osteoporosis · Arthroplasties, Knee Replacement

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202120222023202420252026
  1. Ph 4

    Abaloparatide Before Total Knee Arthroplasty

    NCT04167163

    10 Jan 2020 to 3 Apr 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The investigator hypothesizes that treating osteoporotic patients with abaloparatide prior to and after total knee arthroplasty will significantly reduce the amount of bone loss.

Interventions

  • AbaloparatideDrug

Arms2

  • Active comparator

    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.

  • No intervention

    Comparator group

    Those with clinical osteopenia who receive no treatment.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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)

    Registry description

    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.

Secondary outcomes(11)
  1. Change in Distal Femoral BMD at the 15% and 60% ROI

    Time frame · Baseline and approximately 18 months on study (15 months post-TKA)

    Registry description

    Bone mineral density percent change at the 15% and 60% ROI of the surgical leg

  2. TBS Assessment by TRIP at the 15%, 25%, and 60% Femur ROIs

    Time frame · 18 months on study (15 months post-TKA)

    Registry description

    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).

  3. Knee Injury & Osteoarthritis Outcome Score (KOOS) JR

    Time frame · 18 months on study (15 months post-TKA)

    Registry description

    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.

  4. 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)

    Registry description

    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.

  5. 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)

    Registry description

    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.

  6. Forgotten Joint Survey(FJS) Score

    Time frame · 18 months on study (15 months post-TKA)

    Registry description

    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).

  7. Change in Body Composition Using Bioelectrical Impedance Analysis of Lean Mass

    Time frame · Baseline and approximately 18 months on study (15 months post-TKA)

    Registry description

    Change in total body composition using bioelectrical impedance analysis of lean mass.

  8. Change in Body Composition Using Bioelectrical Impedance Analysis of Fat Mass.

    Time frame · Baseline and approximately 18 months on study (15 months post-TKA)

    Registry description

    Change in total body composition using bioelectrical impedance analysis of fat mass.

  9. TKA Complications: Number of Participants Needed Revision Surgery

    Time frame · 18 months on study (15 months post-TKA)

    Registry description

    TKA complications: Number of participants needed revision surgery

  10. TKA Complications: Number of Participants Had Fracture

    Time frame · 18 months on study (15 months post-TKA)

    Registry description

    TKA complications: Number of participants had fracture

  11. Precision Error on Knee Bone Density Measurement

    Time frame · 18 months on study (15 months post-TKA)

    Registry description

    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 results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and approximately 18 months on study (15 months post-TKA)

Change in Distal Femoral Bone Mineral Density (BMD) at the 25% Regions of Interest (ROIs)

GroupValue (percent change)Spread
Treatment Group3.251.11
Comparator Group-2.421.08
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline and approximately 18 months on study (15 months post-TKA)

Change in Distal Femoral BMD at the 15% and 60% ROI

GroupValue (percent change)Spread
Treatment Group6.601.50
Comparator Group-0.971.46
Secondary outcomeMean· 18 months on study (15 months post-TKA)

TBS Assessment by TRIP at the 15%, 25%, and 60% Femur ROIs

GroupValue (score)Spread
Treatment Group0.9170.113
Comparator Group0.9120.126
Secondary outcomeMean· 18 months on study (15 months post-TKA)

Knee Injury & Osteoarthritis Outcome Score (KOOS) JR

GroupValue (score on a scale)Spread
Treatment Group48.813.1
Comparator Group56.512.7
Secondary outcomeMean· Baseline and approximately 18 months on study (15 months post-TKA)

Change in Veterans RAND 12 (VR-12) Question Health Survey Score: Physical Health Component

GroupValue (score on a scale)Spread
Treatment Group35.310.8
Comparator Group39.210.3
Secondary outcomeMean· 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

GroupValue (score on a scale)Spread
Treatment Group42.33.8
Comparator Group43.25.3
Secondary outcomeMean· 18 months on study (15 months post-TKA)

Forgotten Joint Survey(FJS) Score

GroupValue (score on a scale)Spread
Treatment Group62.827.3
Comparator Group49.526.4
Secondary outcomeMean· Baseline and approximately 18 months on study (15 months post-TKA)

Change in Body Composition Using Bioelectrical Impedance Analysis of Lean Mass

GroupValue (grams)Spread
Treatment Group81802023
Comparator Group76161363

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Treatment GroupThose 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 treatment0 / 293 / 298 / 29
Comparator GroupThose with clinical osteopenia who receive no treatment.0 / 291 / 291 / 29

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies6

Studies that cite this trial.

Studies with results

3 studies on this page

PubMed tag: none · 2026

2 results

Abaloparatide Increases Distal Femur Bone Mineral Density Post-Total Knee Arthroplasty.

Nickel et al. 2026JB & JS open access

PMID 42781663PMC13600578DOI 10.2106/jbjs.oa.26.00176PUB-42781663

Free to read · publisher termsCC BY-NC-ND2 results

PubMed tag: none · 2018

6 results

Teriparatide Administration Increases Periprosthetic Bone Mineral Density After Total Knee Arthroplasty: A Prospective Study.

Suzuki et al. 2018The Journal of arthroplastycited by 39

PMID 28869116DOI 10.1016/j.arth.2017.07.026PUB-28869116

Full text at the publisher6 results

Indexing hint: Randomized controlled trial · 2016

3 results

Teriparatide Versus Alendronate for the Preservation of Bone Mineral Density After Total Hip Arthroplasty - A randomized Controlled Trial.

Kobayashi et al. 2016The Journal of arthroplastycited by 42

PMID 26260784DOI 10.1016/j.arth.2015.07.017PUB-26260784

Full text at the publisher3 results

More studies

3 studies on this page

Indexing hint: Review · 2018

Anabolic agents: what is beyond osteoporosis?

Liu et al. 2018Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USAcited by 28

PMID 29627891PMC5949085DOI 10.1007/s00198-018-4507-8PUB-29627891

Rights unknown
Source link

PubMed tag: none · 2016

Weekly injection of teriparatide for bone ingrowth after cementless total knee arthroplasty.

Kaneko et al. 2016Journal of orthopaedic surgery (Hong Kong)cited by 14

PMID 27122506DOI 10.1177/230949901602400106PUB-27122506

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2016

Corrected

Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial.

Miller et al. 2016JAMAcited by 632

PMID 27533157DOI 10.1001/jama.2016.11136PUB-27533157

Full text at the publisher

Eligibility

Who could join, as posted.

Sex
All
Age
from 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria 1. Post-menopausal women and men age ge ≥ 55 years and scheduled to undergo primary TKA at the University of Wisconsin Total Joint Program. 2. 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. 3. Serum calcium (albumin-corrected), serum creatinine and Parathyroid(PTH) values all within the normal range and 25(OH)D \> 10 ng/mL. 4. Willing to supplement with daily calcium and/or vitamin D3 at protocol specified doses. 5. Able to provide written informed consent. Exclusion Criteria 1. Unevaluable distal femur BMD due to hardware or other artifacts. 2. History of bone disorders (e.g., Paget's disease) other than osteoporosis. 3. History of prior external beam or implant radiation therapy involving the skeleton other than radioiodine. 4. 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. 5. History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism, hypo- or hyperparathyroidism or malabsorptive syndromes within the past year. 6. 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. 7. History of nephrolithiasis or urolithiasis within the past five years. 8. History of cancer in prior 5 years (basal cell or squamous skin cancer is permissible). 9. History of osteosarcoma at any time. 10. Patients known to be positive for Hepatitis B, Hepatitis C, HIV-1 or HIV-2. 11. Known hypersensitivity to any of the test materials or related compounds. 12. Prior treatment with PTH- or PTHrP-derived drugs, (ABL, teriparatide or PTH (1-84)). 13. 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. 14. Treatment with fluoride or strontium in the past five years or prior treatment with bone-acting investigational agents at any time. 15. Treatment with calcitonin the past 6 months or denosumab in the past 18 months. 16. Treatment with anticonvulsants affecting vitamin D metabolism (phenobarbital, phenytoin, carbamazepine or primidone) or chronic heparin within the prior 6 months. 17. Treatment with anabolic steroids or calcineurin inhibitors (cyclosporin, tacrolimus) 18. Daily treatment with oral, intranasal or inhaled glucocorticoids in the prior 12 months. 19. Exposure to any investigational drug within 12 months. 20. Consumption of \> 2 alcoholic drinks per day or use of illegal drugs within 12 months of screening. 21. Not suitable for study participation due to other reasons at the investigators discretion.

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