Can a Bone-Building drug save your new knee?
NCT ID NCT04167163
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether the drug abaloparatide (Tymlos) can reduce bone loss after total knee replacement in people with osteoporosis or osteopenia. 58 participants took the drug for 18 months. The main goal was to see if bone density around the new knee improved compared to before surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- abaloparatide (Tymlos)
- What this could lead to
- If it works, this could point toward a way to prevent bone loss around a new knee joint, improving implant longevity and reducing fracture risk.
- What could go wrong
- This is a small, early-phase study (58 people) with no placebo group, so results may not be conclusive. The drug is already approved for osteoporosis but not for this specific use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
58 people
The number who actually took part.
- Started
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Jan 2020
- Finished
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Apr 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
55 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Wisconsin
Madison, Wisconsin, 53705, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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