Trial Outcomes & Findings for Abaloparatide Before Total Knee Arthroplasty (NCT NCT04167163)
NCT ID: NCT04167163
Last Updated: 2026-06-05
Results Overview
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.
COMPLETED
PHASE4
58 participants
Baseline and approximately 18 months on study (15 months post-TKA)
2026-06-05
Participant Flow
Participants were recruited from the UW Total Joint Program at the American Center and enrolled from January 2020 to August 2023.
Participant milestones
| Measure |
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
|
Comparator Group
Those with clinical osteopenia who receive no treatment.
|
|---|---|---|
|
Overall Study
COMPLETED
|
25
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
|
Overall Study
STARTED
|
29
|
29
|
Reasons for withdrawal
| Measure |
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
|
Comparator Group
Those with clinical osteopenia who receive no treatment.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Abaloparatide Before Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Treatment Group
n=29 Participants
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
|
Comparator Group
n=29 Participants
Those with clinical osteopenia who receive no treatment.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.6 years
STANDARD_DEVIATION 7.1 • n=20 Participants
|
65.8 years
STANDARD_DEVIATION 7.0 • n=20 Participants
|
69.4 years
STANDARD_DEVIATION 7.2 • n=40 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=20 Participants
|
26 Participants
n=20 Participants
|
49 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=20 Participants
|
29 Participants
n=20 Participants
|
58 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=20 Participants
|
29 Participants
n=20 Participants
|
57 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=20 Participants
|
29 participants
n=20 Participants
|
58 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Comparator Group
n=28 Participants
Those with clinical osteopenia who receive no treatment.
|
Treatment Group
n=25 Participants
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
|
|---|---|---|
|
Change in Distal Femoral Bone Mineral Density (BMD) at the 25% Regions of Interest (ROIs)
|
-2.42 percent change
Standard Error 1.08
|
3.25 percent change
Standard Error 1.11
|
SECONDARY outcome
Timeframe: Baseline and approximately 18 months on study (15 months post-TKA)Population: 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.
Bone mineral density percent change at the 15% and 60% ROI of the surgical leg
Outcome measures
| Measure |
Comparator Group
n=29 Participants
Those with clinical osteopenia who receive no treatment.
|
Treatment Group
n=25 Participants
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
|
|---|---|---|
|
Change in Distal Femoral BMD at the 15% and 60% ROI
15 percent ROI
|
-0.97 percent change
Standard Error 1.46
|
6.60 percent change
Standard Error 1.50
|
SECONDARY outcome
Timeframe: 18 months on study (15 months post-TKA)Population: 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.
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).
Outcome measures
| Measure |
Comparator Group
n=28 Participants
Those with clinical osteopenia who receive no treatment.
|
Treatment Group
n=29 Participants
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
|
|---|---|---|
|
TBS Assessment by TRIP at the 15%, 25%, and 60% Femur ROIs
baseline (15% femur ROI)
|
0.912 score
Standard Deviation 0.126
|
0.917 score
Standard Deviation 0.113
|
|
TBS Assessment by TRIP at the 15%, 25%, and 60% Femur ROIs
18 months (15% femur ROI)
|
0.927 score
Standard Deviation 0.125
|
0.934 score
Standard Deviation 0.092
|
|
TBS Assessment by TRIP at the 15%, 25%, and 60% Femur ROIs
baseline (25% femur ROI)
|
1.161 score
Standard Deviation 0.178
|
1.127 score
Standard Deviation 0.140
|
|
TBS Assessment by TRIP at the 15%, 25%, and 60% Femur ROIs
18 months (25% femur ROI)
|
1.171 score
Standard Deviation 0.155
|
1.116 score
Standard Deviation 0.141
|
SECONDARY outcome
Timeframe: 18 months on study (15 months post-TKA)Population: Not all participants completed or returned the surveys.
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.
Outcome measures
| Measure |
Comparator Group
n=25 Participants
Those with clinical osteopenia who receive no treatment.
|
Treatment Group
n=25 Participants
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
|
|---|---|---|
|
Knee Injury & Osteoarthritis Outcome Score (KOOS) JR
baseline
|
56.5 score on a scale
Standard Deviation 12.7
|
48.8 score on a scale
Standard Deviation 13.1
|
|
Knee Injury & Osteoarthritis Outcome Score (KOOS) JR
18 months
|
77.1 score on a scale
Standard Deviation 14.4
|
79.8 score on a scale
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Baseline and approximately 18 months on study (15 months post-TKA)Population: Not all participants completed or returned the surveys.
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.
Outcome measures
| Measure |
Comparator Group
n=25 Participants
Those with clinical osteopenia who receive no treatment.
|
Treatment Group
n=25 Participants
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
|
|---|---|---|
|
Change in Veterans RAND 12 (VR-12) Question Health Survey Score: Physical Health Component
Baseline
|
39.2 score on a scale
Standard Deviation 10.3
|
35.3 score on a scale
Standard Deviation 10.8
|
|
Change in Veterans RAND 12 (VR-12) Question Health Survey Score: Physical Health Component
18 months on study
|
47.2 score on a scale
Standard Deviation 9.8
|
47.9 score on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Baseline and approximately 18 months on study (15 months post-TKA)Population: Not all participants completed or returned the surveys.
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.
Outcome measures
| Measure |
Comparator Group
n=25 Participants
Those with clinical osteopenia who receive no treatment.
|
Treatment Group
n=25 Participants
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
|
|---|---|---|
|
Change in Veterans RAND 12 (VR-12) Question Health Survey Score: Mental Health Component
Baseline
|
43.2 score on a scale
Standard Deviation 5.3
|
42.3 score on a scale
Standard Deviation 3.8
|
|
Change in Veterans RAND 12 (VR-12) Question Health Survey Score: Mental Health Component
18 months on study
|
42.6 score on a scale
Standard Deviation 6.3
|
42.4 score on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: 18 months on study (15 months post-TKA)Population: Some participants did not complete assessment at 18 month time point.
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).
Outcome measures
| Measure |
Comparator Group
n=27 Participants
Those with clinical osteopenia who receive no treatment.
|
Treatment Group
n=25 Participants
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
|
|---|---|---|
|
Forgotten Joint Survey(FJS) Score
|
49.5 score on a scale
Standard Deviation 26.4
|
62.8 score on a scale
Standard Deviation 27.3
|
SECONDARY outcome
Timeframe: Baseline and approximately 18 months on study (15 months post-TKA)Change in total body composition using bioelectrical impedance analysis of lean mass.
Outcome measures
| Measure |
Comparator Group
n=25 Participants
Those with clinical osteopenia who receive no treatment.
|
Treatment Group
n=22 Participants
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
|
|---|---|---|
|
Change in Body Composition Using Bioelectrical Impedance Analysis of Lean Mass
baseline
|
7616 grams
Standard Deviation 1363
|
8180 grams
Standard Deviation 2023
|
|
Change in Body Composition Using Bioelectrical Impedance Analysis of Lean Mass
18 months
|
7436 grams
Standard Deviation 1451
|
7567 grams
Standard Deviation 1987
|
SECONDARY outcome
Timeframe: Baseline and approximately 18 months on study (15 months post-TKA)Change in total body composition using bioelectrical impedance analysis of fat mass.
Outcome measures
| Measure |
Comparator Group
n=25 Participants
Those with clinical osteopenia who receive no treatment.
|
Treatment Group
n=22 Participants
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
|
|---|---|---|
|
Change in Body Composition Using Bioelectrical Impedance Analysis of Fat Mass.
baseline
|
5737 grams
Standard Deviation 2088
|
6412 grams
Standard Deviation 2388
|
|
Change in Body Composition Using Bioelectrical Impedance Analysis of Fat Mass.
18 months
|
5498 grams
Standard Deviation 2145
|
6179 grams
Standard Deviation 2383
|
SECONDARY outcome
Timeframe: 18 months on study (15 months post-TKA)TKA complications: Number of participants needed revision surgery
Outcome measures
| Measure |
Comparator Group
n=29 Participants
Those with clinical osteopenia who receive no treatment.
|
Treatment Group
n=29 Participants
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
|
|---|---|---|
|
TKA Complications: Number of Participants Needed Revision Surgery
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 18 months on study (15 months post-TKA)TKA complications: Number of participants had fracture
Outcome measures
| Measure |
Comparator Group
n=29 Participants
Those with clinical osteopenia who receive no treatment.
|
Treatment Group
n=29 Participants
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
|
|---|---|---|
|
TKA Complications: Number of Participants Had Fracture
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 18 months on study (15 months post-TKA)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).
Outcome measures
| Measure |
Comparator Group
n=29 Participants
Those with clinical osteopenia who receive no treatment.
|
Treatment Group
n=29 Participants
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
|
|---|---|---|
|
Precision Error on Knee Bone Density Measurement
|
1.50 percent coefficient of variation (CV)
|
1.90 percent coefficient of variation (CV)
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and approximately 18 months on study (15 months post-TKA)Cortical thickness change at the 15% and 60% ROI of the surgical leg
Outcome measures
Outcome data not reported
Adverse Events
Treatment Group
Comparator Group
Serious adverse events
| Measure |
Treatment Group
n=29 participants at risk
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
|
Comparator Group
n=29 participants at risk
Those with clinical osteopenia who receive no treatment.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/29 • 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)
|
3.4%
1/29 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.4%
1/29 • 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)
|
0.00%
0/29 • 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)
|
|
General disorders
Chest Pain
|
3.4%
1/29 • 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)
|
0.00%
0/29 • 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)
|
|
Injury, poisoning and procedural complications
Motor Vehicle Accident
|
3.4%
1/29 • 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)
|
0.00%
0/29 • 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)
|
Other adverse events
| Measure |
Treatment Group
n=29 participants at risk
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
|
Comparator Group
n=29 participants at risk
Those with clinical osteopenia who receive no treatment.
|
|---|---|---|
|
Nervous system disorders
Lightheadedness
|
10.3%
3/29 • 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)
|
3.4%
1/29 • 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)
|
|
Cardiac disorders
Tachycardia
|
10.3%
3/29 • 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)
|
0.00%
0/29 • 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)
|
|
Gastrointestinal disorders
Nausea
|
6.9%
2/29 • 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)
|
0.00%
0/29 • 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)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place