Status:
TERMINATED
Teriparatide for Postsurgical Hypoparathyroidism
Lead Sponsor:
Mayo Clinic
Conditions:
Hypoparathyroidism Post-surgical
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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...
Detailed Description
Transient hypoparathyroidism with hypocalcemia occurs in up to 20 % of patients after surgery for thyroid cancer, multinodular goiter or Graves' disease and is severe in around 3 to 18% of cases. Seve...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01171690
Start Date
November 1 2010
End Date
December 1 2013
Last Update
December 22 2014
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905