Teriparatide as a Chondroregenerative Therapy in OA (NCT03072147) | Clinical Trial Compass
CompletedPhase 2
Teriparatide as a Chondroregenerative Therapy in OA
United States76 participantsStarted 2017-05-01
Plain-language summary
The purpose of this study is to evaluate teriparatide (TP) as a chondroregenerative therapy for human knee osteoarthritis (OA). The central hypothesis to be tested is that TP supports structural modification of the joint and improves biomarker, functional and patient-reported measures of knee OA.
Who can participate
Age range40 Years – 60 Years
SexALL
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Inclusion criteria
✓. male or female 40 to 60 years old.
✓. radiographic evidence of Kellgren-Lawrence score (K-L score) grade I-II OA in the affected knee
✓. unilateral symptomatic knee OA
✓. willingness to forgo potential standard of care treatments (hyaluronic acid and cortisol injections) for knee pain for the duration of the study
✓. body Mass Index of ≤40
✓. normal screening vitamin D levels (≥20 and ≤100 mg/ml)
✓. normal screening serum calcium level (8.5- 10.2 mg/dL)
✓. a negative screening serum pregnancy test for premenopausal women
Exclusion criteria
✕. history of primary hyperparathyroidism disease, hypercalcemia, or persistently abnormal intake PTH levels (≥10 or ≤65 pg/ml)
✕. history of musculoskeletal malignancy or solid organ carcinoma
✕. active renal disease defined by a creatinine clearance of \<35 or history of kidney stones within the past year
✕. severe claustrophobia, retained eye or skull metal fragments, metal hardware in or around the affected knee or other standard contraindications to MRI (cochlear implants, pacemakers)