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

This study has been terminated.
(Terminated due to slow accrual.)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00623974
First received: February 14, 2008
Last updated: December 4, 2012
Last verified: December 2012
  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,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.


Condition Intervention Phase
Hypocalcemia
Drug: Teriparatide (Forteo)
Drug: Calcium
Drug: Calcitriol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Short-Term Use of Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Patients With Success [ Time Frame: 2 - 7 days post-treatment ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 7
Study Start Date: May 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcium + Calcitriol
1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
Drug: Calcium
1000 milligrams by mouth (PO) Every 12 Hours
Drug: Calcitriol
0.25 micrograms PO Every 12 Hours
Other Name: Rocaltrol
Experimental: Teriparatide 20 mcg
Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
Drug: Teriparatide (Forteo)
Subcutaneous Injection Every 12 Hours for 7 Days
Other Names:
  • Forteo
  • PTH
  • Parathyroid Hormone
Drug: Calcium
1000 milligrams by mouth (PO) Every 12 Hours
Drug: Calcitriol
0.25 micrograms PO Every 12 Hours
Other Name: Rocaltrol
Experimental: Teriparatide 40 mcg
Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
Drug: Teriparatide (Forteo)
Subcutaneous Injection Every 12 Hours for 7 Days
Other Names:
  • Forteo
  • PTH
  • Parathyroid Hormone
Drug: Calcium
1000 milligrams by mouth (PO) Every 12 Hours
Drug: Calcitriol
0.25 micrograms PO Every 12 Hours
Other Name: Rocaltrol
Experimental: Teriparatide 60 mcg
Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
Drug: Teriparatide (Forteo)
Subcutaneous Injection Every 12 Hours for 7 Days
Other Names:
  • Forteo
  • PTH
  • Parathyroid Hormone
Drug: Calcium
1000 milligrams by mouth (PO) Every 12 Hours
Drug: Calcitriol
0.25 micrograms PO Every 12 Hours
Other Name: Rocaltrol

  Show Detailed Description

  Eligibility

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

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

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eli Lilly and Company
Investigators
Principal Investigator: Mimi Hu, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00623974     History of Changes
Other Study ID Numbers: 2006-0562
Study First Received: February 14, 2008
Results First Received: August 13, 2010
Last Updated: December 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Hypocalcemia
Teriparatide
Forteo
Calcium
Calcitriol
Rocaltrol

Additional relevant MeSH terms:
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Calcitriol
Calcium, Dietary
Teriparatide
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014