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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II Study of Short-Term Use of Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia

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 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.


Detailed Summary:

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 for low calcium in the blood.

After scheduled surgery, the level of calcium in the blood will be monitored according to the standard of care. Between 18 and 24 hours after the surgery, if calcium level drops below an acceptable level, or participants develop symptoms of low calcium, they will be randomly assigned (as in the toss of a coin) to 1 of 4 groups. One group (the "standard-of-care" group) will receive calcium plus calcitriol alone, for 7 days. The other groups (the "teriparatide" groups) will receive 1 of 3 different dose levels of teriparatide for 7 days, plus calcium and calcitriol for 7 days. There is an equal chance of getting assigned to any of these 4 groups, for the first 40 participants enrolled on this study. If enrolled after that point, participants will have a greater chance of being assigned to the group showing the best results.

Standard-of-Care Group:

If assigned to the standard-of-care group, participant will receive calcium and calcitriol according to the standard schedule and dose. The calcium will either be given through a vein or by mouth, and calcitriol will be given by mouth.

Teriparatide Group:

If assigned to a teriparatide group, participant will receive teriparatide by an injection under the skin, twice a day for 7 days. They will be taught how to perform the injections themselves, with a pen-sized device. While in the hospital, the hospital staff will watch them perform the injections and offer help, if needed. If discharged fr
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Number of Patients With Success [ Time Frame: 2 - 7 days post-treatment ]

A patient "success" is defined as a normal calcium level (Ca>=8 and Ca<= 10.5) within 48 hours post-treatment initiation and a normal Ca level maintained through day 7 post-treatment initiation.


Original Primary Outcome: 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. [ Time Frame: 3 Years ]

Current Secondary Outcome:

Original Secondary Outcome: The safety of teriparatide in treating low blood calcium levels will also be studied. [ Time Frame: 3 Years ]

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: February 14, 2008
Date Started: May 2008
Date Completion:
Last Updated: December 4, 2012
Last Verified: December 2012