Pilot Study of Teriparatide for Postsurgical Hypoparathyroidism

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

This study will evaluate the effects of teriparatide (synthetic parathyroid hormone, brand name Forteo) on low calcium levels in the setting of thyroid surgery associated with low parathyroid hormone.

Who is eligible to participate?

Inclusion criteria: - Patients post bilateral thyroid bed surgery (cancer, Graves' disease, multinodular goiter) - Symptomatic hypocalcemia - Total calcium < 8 mg/dL persisting after 24 hours of therapy with calcitriol (minimum 0.25 mcg twice a day) and calcium supplementation (minimum 1.5 grams of elemental calcium per day) - Parathyroid hormone (PTH) level below low end of normal range Exclusion criteria: - Renal failure - Any prior parathyroid pathology - Pre-existing hypercalcemia - Metabolic bone diseases other than osteoporosis - Paget's disease - Ongoing therapy with Forteo for osteoporosis - Active non-thyroidal malignancy or suspicion of residual thyroid malignancy - History of skeletal malignancies, primary or metastatic - Pregnancy - Active or recent urolithiasis - Digitalis therapy - Patients at increased baseline risk for osteosarcoma, i.e. family history of osteosarcoma or prior radiation therapy involving the skeleton - Pediatric populations - Unexplained elevations of alkaline phosphatase

Last updated:

8/11/2014

NCT ID:

NCT01171690

IRB Number:

10-000901