New Osteoporosis Patch Study: Recruiting Postmenopausal Women

Posted on November 04, 2019

Source: Cleveland Clinic

New Tymlos Patch Study

The trial compares Abaloparatide/Tymlos(R) injection vs Tymlos(R) patch. The patch is applied for 10 minutes daily and avoids the need for daily subcutaneous injection.

Every woman with osteoporosis who gets enrolled in this study will receive active treatment free of charge in that there is no placebo group. Patients are randomized to either daily injection or patch.

The study is 12 months and requires about 14 visits to Cleveland Clinic's main campus. Parking, mileage, lunch and a stipend are covered. The main cost is the participant's time.

Inclusion Criteria:

1. Postmenopausal women ages 50-85
2. T-score -2.5 to -5.0 (If over age 65: T-score -2.0 to -5.0)
3. 2 mild or 1 moderate vertebral fracture, or a non-vertebral fracture (ribs, wrist, MT, humerus etc) in last 5 years
4. If over age 65, can enter with no fracture if the T-score is -3.0 to -5.0

Exclusion Criteria:

1. Tymlos(R) or Forteo(R) at any time
2. IV Reclast/Zoledrinic Acid at any time
3. Prolia(R)/Denosunaub if in last 18 months
4. Oral bisphosphonate <3m in last 3 years (more than 6 months ago) like Fosamax(R), Actinrl(R), Bo Iva (R)
5. Evista/Raloxifene in last 6 months (estrogen therapy is fine)
6. Prednisone >5mg per day (5mg daily or less is fine)
7. Creatinine >2.0
8. Severe vertebral fracture (height loss >40%)
9. Cancer within the last 5 years (skin cancer is not exclusionary)
10. Any XRay therapy/radiation therapy

If you are interested in participating in this study, please contact Dr. Chad Deal’s office at 216-444-6575.