Status:
TERMINATED
Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Hypocalcemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary Objective: -To identify the optimal dose of a seven-day course of twice-daily teriparatide as compared to standard therapy for hypocalcemia in patients after total thyroidectomy and/or extens...
Detailed Description
Teriparatide is designed to act like a natural human hormone called parathyroid hormone, which can increase the blood levels of calcium. Calcium plus calcitriol is considered the standard treatment fo...
Eligibility Criteria
Inclusion
- Patients who are scheduled for total thyroidectomy, and/or extensive neck dissections (pharyngectomy, laryngectomy, unilateral/bilateral/central neck, and/or mediastinal lymph node neck dissections).
- Patients who develop, between 18-24 hours after surgery, hypocalcemia as defined by a corrected serum calcium \<8.0mg/dL. \[Corrected serum calcium (mg/dL) = Measured calcium + (4-albumin) x 0.8\]
Exclusion
- Patients who have jejunal tubes
- Patients \<18 years old.
- Treatment with teriparatide or calcitriol (Rocaltrol) within 1 month prior to surgery
- Treatment with a bisphosphonate within 3 months prior to surgery
- Hypercalcemia (corrected serum calcium \>10.5mg/dL) or hypocalcemia (corrected serum calcium \<8.4mg/dL) on preoperative labs (drawn within 21 days of surgery)
- Paget's disease of bone
- Elevated alkaline phosphatase \> institutional upper limit of normal (ULN)
- History of external beam irradiation to the skeleton
- History of skeletal metastases
- History of untreated gout
- History of unstable angina pectoris
- History of symptomatic orthostatic hypotension
- Pregnancy (as screened by a serum/urine pregnancy test) or breast-feeding. Female subjects of childbearing potential must have a negative pregnancy test within 7 days of surgery. Postmenopausal women (absence of menses for 12 months) or women with history of hysterectomy or bilateral oophorectomy will not be required to have a pregnancy test. Male and female patients of reproductive potential must agree to utilize an effective form of contraception throughout the study period. The definition of effective contraception will be based on the judgment of the Investigator or designated associate.
- Hepatic and renal dysfunction defined by the following parameters: (a) Serum AST (SGOT) and ALT (SGPT) \> 3 times the institutional ULN, (b) Total serum bilirubin \> 2 times the institutional ULN, (c) Serum creatinine \> 1.5mg/dL or estimated creatinine clearance \< 40mL/min
- Psychiatric illness or social situation that would limit compliance with study requirements
- Concomitant use of digoxin
- Patients may not be receiving any other investigational agents or have participated in any investigational drug study within 28 days preceding the start of study treatment.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00623974
Start Date
May 1 2008
End Date
June 1 2010
Last Update
December 6 2012
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030