Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia - Full Text View

Purpose

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, bilateral paratracheal, 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.

Condition	Intervention	Phase
Hypocalcemia	Drug: Teriparatide Drug: Calcium Drug: Calcitriol	Phase II

Drug Information available for:

Calcium gluconate Calcitriol Teriparatide Teriparatide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The safety of teriparatide in treating low blood calcium levels will also be studied. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	May 2008
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Calcium + Calcitriol	Drug: Calcium 1000 milligrams PO Every 12 Hours Drug: Calcitriol 0.25 micrograms PO Every 12 Hours
2: Experimental Teriparatide at 20 mcg + Calcium + Calcitriol	Drug: Teriparatide Subcutaneous Injection Every 12 Hours for 7 Days Drug: Calcium 1000 milligrams PO Every 12 Hours Drug: Calcitriol 0.25 micrograms PO Every 12 Hours
3: Experimental Teriparatide at 40 mcg + Calcium + Calcitriol	Drug: Teriparatide Subcutaneous Injection Every 12 Hours for 7 Days Drug: Calcium 1000 milligrams PO Every 12 Hours Drug: Calcitriol 0.25 micrograms PO Every 12 Hours
4: Experimental Teriparatide at 60 mcg + Calcium + Calcitriol	Drug: Teriparatide Subcutaneous Injection Every 12 Hours for 7 Days Drug: Calcium 1000 milligrams PO Every 12 Hours Drug: Calcitriol 0.25 micrograms PO Every 12 Hours

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who are scheduled for total thyroidectomy, pharyngectomy, laryngectomy, bilateral paratracheal 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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623974

Contacts


Contact: Mimi Hu, MD	713-792-2841

Locations


United States, Texas
	U.T.M.D. Anderson Cancer Center	Recruiting
	Houston, Texas, United States, 77030
	Principal Investigator: Mimi Hu, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Eli Lilly and Company

Investigators


Principal Investigator:	Mimi Hu, MD	U.T.M.D. Anderson Cancer Center

More Information

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Mimi Hu, MD/Assistant Professor )
Study ID Numbers:	2006-0562
First Received:	February 14, 2008
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00623974
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Hypocalcemia

Teriparatide

Forteo

Calcium

Calcitriol

Rocaltrol

Study placed in the following topic categories:

Hypocalcemia

Metabolic Diseases

Teriparatide

Water-Electrolyte Imbalance

Metabolic disorder

Calcitriol

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Growth Substances

Physiological Effects of Drugs

Calcium Channel Agonists

Bone Density Conservation Agents

Cardiovascular Agents

Pharmacologic Actions

Calcium Metabolism Disorders

Membrane Transport Modulators

Vitamins

Therapeutic Uses

Vasoconstrictor Agents

Micronutrients

ClinicalTrials.gov processed this record on December 03, 2008

Sponsors and Collaborators:	M.D. Anderson Cancer Center Eli Lilly and Company
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00623974