Abaloparatide Before Total Knee Arthroplasty

NCT04167163 | Completed Phase 4 FDA Drug

• 4 other identifiers: 2019-0685A534255SMPH/MEDICINE/MEDICINE*GProtocol Version 3/22/2021
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis; Arthroplasties, Knee Replacement

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and 18 months

Secondary Outcomes (12)

• Change in Distal femoral BMD at the 15% and 60 %ROI

  Baseline and 18 months

• Change in Femur cortical thickness at the 15%, 25% and 60% femur ROIs

  Baseline and 18 months

• TBS assessment by TRIP at the 15%, 25% and 60% femur ROIs

  18 months

• Knee injury & Osteoarthritis Outcome Score (KOOS) JR

  18 months

• Change in Veterans RAND 12 (VR-12) Question Health Survey score

  Baseline and 18 months

Study Arms (2)

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.

Drug: Abaloparatide

Comparator group

NO INTERVENTION

Those with clinical osteopenia who receive no treatment.

Interventions

Abaloparatide DRUG

18 month ABL treatment

Also known as: Tymlos

Treatment group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Radius Health, Inc.: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (43)

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MeSH Terms

Conditions

Osteoporosis

Interventions

abaloparatide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Neil Binkley, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 18, 2019
• Study Start: January 10, 2020
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)