MDACC Study Summary 2006-0562 (Archived)

Study Summary
No. 2006-0562:.......Endocrine; Head And Neck; Other Supportive; Thyroid......Mimi Hu......Endocrine Neoplasia & Hormonal Disorders

Study Summary Title



Study Summary Number:	2006-0562

Study Title:	A phase II study of short-term use of teriparatide (Forteo) in the treatment of patients with postoperative hypocalcemia.

Physician

New Patient Referral



Name:	Mimi Hu	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Endocrine Neoplasia & Hormonal Disorders	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2841 Contact us about clinical trials

General Information



Disease Group:	Endocrine Head And Neck Other Supportive Thyroid	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	As determined appropriate by the research team, primary or consulting services.

Treatment Agents:	Teriparatide	Home Care:	Patients may be administering teriparatide at home for a total treatment duration of 7 days.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Depends on the patient's postoperative recovery. Time of discharge will be a decision made by the multidisciplinary team of primary and consulting services and if sCa is stable, rising, and >7.5mg/dL and patient is free of hypocalcemic symptoms.


Description/ Intervention:	The goal of this clinical research study is to see if Forteo (teriparatide) can help return the calcium level in the blood to normal if it becomes low after certain types of surgery. These surgery types include thyroid removal or neck surgery for head and neck cancers. The safety of teriparatide in treating low blood calcium levels will also be studied.

Study Objectives / Outcomes

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.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	11/21/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) 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).

2) 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 Criteria:

1) Patients who have jejunal tubes

2) Patients <18 years old.

3) Treatment with teriparatide or calcitriol (Rocaltrol) within 1 month prior to surgery

4) Treatment with a bisphosphonate within 3 months prior to surgery

5) Hypercalcemia (corrected serum calcium >10.5mg/dL) or hypocalcemia (corrected serum calcium <8.4mg/dL) on preoperative labs (drawn within 21 days of surgery)

6) Paget's disease of bone

7) Elevated alkaline phosphatase > institutional upper limit of normal (ULN)

8) History of external beam irradiation to the skeleton

9) History of skeletal metastases

10) History of untreated gout

11) History of unstable angina pectoris

12) History of symptomatic orthostatic hypotension

13) 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.

14) 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

15) Psychiatric illness or social situation that would limit compliance with study requirements

16) Concomitant use of digoxin

17) 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.

Links

Registration Number: NCT00623974
Study Information on Clinical Trials Registry (clinicaltrials.gov)