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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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

Overview

Status
Terminated
Phase
Phase 2
Enrollment
7 participants (actual)
Sponsor
M.D. Anderson Cancer Center · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
May 2008
Primary completion
Jun 2010
Completion
Jun 2010
First posted
26 Feb 2008 (estimated)
Last update posted
6 Dec 2012 (estimated)
Conditions
Hypocalcemia

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2008200920102011
  1. Ph 2

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

    NCT00623974

    May 2008 to Jun 2010

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Teriparatide (Forteo)Drug
  • CalciumDrug
  • CalcitriolDrug

Arms4

  • Experimental

    Calcium + Calcitriol

    1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours

  • Experimental

    Teriparatide 20 mcg

    Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours

  • Experimental

    Teriparatide 40 mcg

    Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours

  • Experimental

    Teriparatide 60 mcg

    Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Patients With Success

    Time frame · 2 - 7 days post-treatment

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 2 - 7 days post-treatment

Number of Patients With Success

GroupValue
Calcium + Calcitriolnot posted
Teriparatide 20 Mcgnot posted
Teriparatide 40 Mcgnot posted
Teriparatide 60 Mcgnot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Calcium + Calcitriol1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours–0 / 00 / 0
Teriparatide 20 McgTeriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours–0 / 00 / 0
Teriparatide 40 McgTeriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours–0 / 00 / 0
Teriparatide 60 McgTeriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours–0 / 00 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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