Teriparatide for Postsurgical Hypoparathyroidism

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluated the effects of teriparatide (Forteo) on low calcium levels in the setting of thyroid surgery associated with low parathyroid hormone. The hypothesis was that teriparatide ( Forteo) would shorten the length of hospitalization post thyroidectomy in patients with symptomatic hypoparathyroidism.

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

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Teriparatide

Criteria

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 (all subjects):

• Renal failure

• Any prior parathyroid pathology

• Pre-existing hypercalcemia

• Metabolic bone diseases other than osteoporosis

• Pagets disease

Exclusion criteria (active treatment subjects only):

• 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