Teriparatide for Postsurgical Hypoparathyroidism
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypoparathyroidism Post-surgical
Intervention: Teriparatide (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s): Marius Stan, MD, Principal Investigator, Affiliation: Mayo Clinic
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.
Clinical Details
Official title: Pilot Study of Teriparatide for Postsurgical Hypoparathyroidism
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Hospital Length of Stay
Secondary outcome: Safety Analysis
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. Severe hypocalcemia significantly lengthens their hospital stay. 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.
This was a feasibility open-label, single-arm trial with historical matched controls with a
planned enrollment of 15 patients with severe, symptomatic hypocalcemia that would be
treated with teriparatide for a maximum duration of 3 weeks and compared the active subjects
with 30 gender and age matched controls.
Therapy for hypocalcemia continued in accordance with current practice. The decision for
discharge, as far as calcium is concerned, was to be reached when calcium level was > 7. 5
mg/dL and increased x 2 over 12 hours in an asymptomatic patient with stable therapy and no
need for IV calcium in the last 24 hours. Subjects were followed by phone and with blood
tests 2 days after discharge and 9, 17 and 25 days after initiation of teriparatide. They
were off teriparatide for 24 hours prior to testing on days 9, 17 and 25.
If hypocalcemia recurred after 2nd week, teriparatide was continued for a 3rd week and then
discontinued. If hypocalcemia recurred again current standard therapy for hypoparathyroidism
was continued off teriparatide.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information
Starting date: November 2010
Last updated: December 19, 2014
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