Teriparatide for Postsurgical Hypoparathyroidism
Stopped early · Phase 2
Conditions studied: Hypoparathyroidism Post-surgical
In brief
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.
Key facts
- Study ID
- NCT01171690
- Run by
- Mayo Clinic
- People needed
- 5
- Starts
- 2010-11-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2014-12-22
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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