Study Stopped
Terminated due to slow accrual.
Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia
A Phase II Study of Short-Term Use of Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2008
CompletedFirst Posted
Study publicly available on registry
February 26, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
September 13, 2010
CompletedDecember 6, 2012
December 1, 2012
2.1 years
February 14, 2008
August 13, 2010
December 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients With Success
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.
2 - 7 days post-treatment
Study Arms (4)
Calcium + Calcitriol
EXPERIMENTAL1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
Teriparatide 20 mcg
EXPERIMENTALTeriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
Teriparatide 40 mcg
EXPERIMENTALTeriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
Teriparatide 60 mcg
EXPERIMENTALTeriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
Interventions
Subcutaneous Injection Every 12 Hours for 7 Days
1000 milligrams by mouth (PO) Every 12 Hours
0.25 micrograms PO Every 12 Hours
Eligibility Criteria
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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Eli Lilly and Companycollaborator
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mimi Hu, MD / Professor
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Mimi Hu, MD
UT MD Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2008
First Posted
February 26, 2008
Study Start
May 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
December 6, 2012
Results First Posted
September 13, 2010
Record last verified: 2012-12