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A Phase II Study of Short-Term Use of Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia

Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase II Study of Short-Term Use of Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia

Teriparatide is designed to act like a natural human hormone called parathyroid hormone,
which can increase the blood levels of calcium. Calcium plus calcitriol is considered the
standard treatment for low calcium in the blood.

After scheduled surgery, the level of calcium in the blood will be monitored according to
the standard of care. Between 18 and 24 hours after the surgery, if calcium level drops
below an acceptable level, or participants develop symptoms of low calcium, they will be
randomly assigned (as in the toss of a coin) to 1 of 4 groups. One group (the
"standard-of-care" group) will receive calcium plus calcitriol alone, for 7 days. The other
groups (the "teriparatide" groups) will receive 1 of 3 different dose levels of teriparatide
for 7 days, plus calcium and calcitriol for 7 days. There is an equal chance of getting
assigned to any of these 4 groups, for the first 40 participants enrolled on this study. If
enrolled after that point, participants will have a greater chance of being assigned to the
group showing the best results.

Standard-of-Care Group:

If assigned to the standard-of-care group, participant will receive calcium and calcitriol
according to the standard schedule and dose. The calcium will either be given through a
vein or by mouth, and calcitriol will be given by mouth.

Teriparatide Group:

If assigned to a teriparatide group, participant will receive teriparatide by an injection
under the skin, twice a day for 7 days. They will be taught how to perform the injections
themselves, with a pen-sized device. While in the hospital, the hospital staff will watch
them perform the injections and offer help, if needed. If discharged from the hospital and
sent home before the 7 days of therapy are complete, they will continue giving themselves
the injections (through Day 7) at home. The pen should not be removed from refrigeration
for more than 2 -4 hours. Depending on what dose level of teriparatide assigned to receive,
they may have to give themselves up to 3 injections each time. In addition to teriparatide,
they will receive calcium and calcitriol, according to the standard schedule and dose. The
calcium will either be given through a vein or by mouth, and calcitriol by mouth.

Both Groups:

If blood calcium level has not returned to normal after the 7 days of treatment,
participants may need to continue receiving calcium and/or calcitriol for as long as the
doctor decides it is necessary.

They will be asked to keep a medication log (diary) of when they take the teriparatide
and/or calcium/calcitriol. The log should be returned to the research nurse on Day 8.

On Days 1-7, blood will be drawn to check the level of calcium twice a day (while in the
hospital) or once a day (while treated as an outpatient). These blood draws (about 1
teaspoon each time) will be performed 2 hours before receiving teriparatide and/or

Blood will also be drawn to check calcium and parathyroid hormone levels after the study
treatment is over. The first of these blood draws (about 1 tablespoon each time) will be
performed at 3 days after receiving last dose of teriparatide and/or last dose of
calcium/calcitriol. The second blood draw will be performed at 4 weeks after the surgery.

Starting on Day 7, and again at 4 weeks after surgery, they will be asked to collect urine
over the course of a 24-hour period so calcium levels can be measured.

From Day 1 to Day 7, if discharged from the hospital and sent home, the study personnel will
call on the phone once a day to see how participants are doing. At 3 days after receiving
the last dose of teriparatide and/or the last dose of calcium/calcitriol, and at 4 weeks
after the surgery, they will be called again.

After the urine collection, blood draw, and phone call at 4 weeks after the surgery,
participation in the study is over.

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients With Success

Outcome 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.

Outcome Time Frame:

2 - 7 days post-treatment

Safety Issue:


Principal Investigator

Mimi Hu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2008

Completion Date:

June 2010

Related Keywords:

  • Hypocalcemia
  • Hypocalcemia
  • Teriparatide
  • Forteo
  • Calcium
  • Calcitriol
  • Rocaltrol
  • Hypocalcemia



UT MD Anderson Cancer Center Houston, Texas  77030