Teriparatide as a Chondroregenerative Therapy in OA

• Status: Active, not recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Zuscik; Mike Zuscik
• Collaborators: Duke University; Eli Lilly and Company; Milton S. Hershey Medical Center; University of Rochester
• Treatments: Teriparatide

Criteria

Inclusion Criteria:

1. male or female 40 to 60 years old.

2. radiographic evidence of Kellgren-Lawrence score (K-L score) grade I-II OA in the affected knee

3. unilateral symptomatic knee OA

4. willingness to forgo potential standard of care treatments (hyaluronic acid and cortisol injections) for knee pain for the duration of the study

5. body Mass Index of ≤40

6. normal screening vitamin D levels (≥20 and ≤100 mg/ml)

7. normal screening serum calcium level (8.5- 10.2 mg/dL)

8. a negative screening serum pregnancy test for premenopausal women

Exclusion Criteria:

1. history of primary hyperparathyroidism disease, hypercalcemia, or persistently abnormal intake PTH levels (≥10 or ≤65 pg/ml)

2. history of musculoskeletal malignancy or solid organ carcinoma

3. active renal disease defined by a creatinine clearance of <35 or history of kidney stones within the past year

4. use of anticonvulsant or digoxin therapy

5. inflammatory disease (bowel disease, spondylitis, lupus, fibromyalgia, psoriasis, rheumatoid arthritis, etc)

6. current or past treatment with teriparatide

7. use of immunosuppressants

8. 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)

9. dementia, cognitive impairment or other factors that referring provider feels would prevent ability to obtain informed consent and/or follow study protocol

10. pregnancy or intent to become pregnant in the two and a half years following enrollment

11. women who are currently breastfeeding

12. Paget's disease

13. osteoporosis diagnosis by DXA in medical history (T-score less than or equal to -2.5)

14. reliance on assistive walking devices (canes, walkers, braces, etc.)

15. participation in concurrent clinical studies involving investigational medications