Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia
This study has been terminated.
(Terminated due to slow accrual.)
Sponsor:
M.D. Anderson Cancer Center
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
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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:
MedlinePlus related topics:
Calcium
Drug Information available for:
Calcium Gluconate
Parathyroid Hormone
Calcitriol
Teriparatide
Teriparatide acetate
U.S. FDA Resources
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:
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:
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:
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:
- 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]
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
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 May 16, 2013