Abaloparatide Before Total Knee Arthroplasty

Korábbi kezelés

• History of prior external beam or implant radiation therapy involving the skeleton other than radioiodine.
• 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.
• Treatment with anticonvulsants affecting vitamin D metabolism (phenobarbital, phenytoin, carbamazepine or primidone) or chronic heparin within the prior 6 months.
• Treatment with anabolic steroids or calcineurin inhibitors (cyclosporin, tacrolimus)
• Daily treatment with oral, intranasal or inhaled glucocorticoids in the prior 12 months.
• Exposure to any investigational drug within 12 months.
• Consumption of > 2 alcoholic drinks per day or use of illegal drugs within 12 months of screening.

Más betegség

• History of bone disorders (e.g., Paget's disease) other than osteoporosis.
• 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 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.

Laborértékek

• 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.

Egyéb

• Unevaluable distal femur BMD due to hardware or other artifacts.
• Not suitable for study participation due to other reasons at the investigators discretion.

• 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.