Change in Distal Femoral Bone Mineral Density (BMD) at the 25% Regions of Interest (ROIs)
| Group | Value (percent change) | Spread |
|---|---|---|
| Treatment Group | 3.25 | 1.11 |
| Comparator Group | -2.42 | 1.08 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
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.
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.
Outcomes the sponsor listed as primary.
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.
Change in Distal Femoral BMD at the 15% and 60% ROI
Time frame · Baseline and approximately 18 months on study (15 months post-TKA)
Bone mineral density percent change at the 15% and 60% ROI of the surgical leg
TBS Assessment by TRIP at the 15%, 25%, and 60% Femur ROIs
Time frame · 18 months on study (15 months post-TKA)
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).
Knee Injury & Osteoarthritis Outcome Score (KOOS) JR
Time frame · 18 months on study (15 months post-TKA)
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.
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)
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.
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)
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.
Forgotten Joint Survey(FJS) Score
Time frame · 18 months on study (15 months post-TKA)
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).
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 total body composition using bioelectrical impedance analysis of lean mass.
Change in Body Composition Using Bioelectrical Impedance Analysis of Fat Mass.
Time frame · Baseline and approximately 18 months on study (15 months post-TKA)
Change in total body composition using bioelectrical impedance analysis of fat mass.
TKA Complications: Number of Participants Needed Revision Surgery
Time frame · 18 months on study (15 months post-TKA)
TKA complications: Number of participants needed revision surgery
TKA Complications: Number of Participants Had Fracture
Time frame · 18 months on study (15 months post-TKA)
TKA complications: Number of participants had fracture
Precision Error on Knee Bone Density Measurement
Time frame · 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).
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percent change) | Spread |
|---|---|---|
| Treatment Group | 3.25 | 1.11 |
| Comparator Group | -2.42 | 1.08 |
| Group | Value (percent change) | Spread |
|---|---|---|
| Treatment Group | 6.60 | 1.50 |
| Comparator Group | -0.97 | 1.46 |
| Group | Value (score) | Spread |
|---|---|---|
| Treatment Group | 0.917 | 0.113 |
| Comparator Group | 0.912 | 0.126 |
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Treatment Group | 48.8 | 13.1 |
| Comparator Group | 56.5 | 12.7 |
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Treatment Group | 35.3 | 10.8 |
| Comparator Group | 39.2 | 10.3 |
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Treatment Group | 42.3 | 3.8 |
| Comparator Group | 43.2 | 5.3 |
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Treatment Group | 62.8 | 27.3 |
| Comparator Group | 49.5 | 26.4 |
| Group | Value (grams) | Spread |
|---|---|---|
| Treatment Group | 8180 | 2023 |
| Comparator Group | 7616 | 1363 |
| Group | Deaths | Serious events | Other 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 treatment | 0 / 29 | 3 / 29 | 8 / 29 |
| Comparator GroupThose with clinical osteopenia who receive no treatment. | 0 / 29 | 1 / 29 | 1 / 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
Studies that cite this trial.
3 studies on this page
PubMed tag: none · 2026
Nickel et al. 2026JB & JS open access
PMID 42781663PMC13600578DOI 10.2106/jbjs.oa.26.00176PUB-42781663
PubMed tag: none · 2018
Suzuki et al. 2018The Journal of arthroplastycited by 39
PMID 28869116DOI 10.1016/j.arth.2017.07.026PUB-28869116
Indexing hint: Randomized controlled trial · 2016
Kobayashi et al. 2016The Journal of arthroplastycited by 42
PMID 26260784DOI 10.1016/j.arth.2015.07.017PUB-26260784
3 studies on this page
Indexing hint: Review · 2018
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
PubMed tag: none · 2016
Kaneko et al. 2016Journal of orthopaedic surgery (Hong Kong)cited by 14
PMID 27122506DOI 10.1177/230949901602400106PUB-27122506
Indexing hint: Randomized controlled trial · 2016
Miller et al. 2016JAMAcited by 632
PMID 27533157DOI 10.1001/jama.2016.11136PUB-27533157
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