Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia

Stopped early · Phase 2

Conditions studied: Hypocalcemia

In brief

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 extensive neck dissections (pharyngectomy, laryngectomy,unilateral, bilateral / central neck, mediastinal lymph node neck dissections), with which serum calcium will be raised to corrected serum calcium levels of 8-10.5mg/dL and maintained within this range until the end of the treatment course.

Key facts

Study ID

NCT00623974

Run by

M.D. Anderson Cancer Center

People needed

7

Starts

2008-05-01

Expected to finish

2010-06-01

Last updated by the study team

2012-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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]

You may not qualify if…

• 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.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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