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

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ClinicalTrials.gov Identifier: NCT00623974
Recruitment Status : Terminated (Terminated due to slow accrual.)
First Posted : February 26, 2008
Results First Posted : September 13, 2010
Last Update Posted : December 6, 2012
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.


Condition or disease Intervention/treatment Phase
Hypocalcemia Drug: Teriparatide (Forteo) Drug: Calcium Drug: Calcitriol Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00623974     History of Changes
Other Study ID Numbers: 2006-0562
First Posted: February 26, 2008    Key Record Dates
Results First Posted: September 13, 2010
Last Update Posted: December 6, 2012
Last Verified: December 2012

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
Calcium, Dietary
Teriparatide
Calcitriol
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances