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.
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.
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.
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Success
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.
2 - 7 days post-treatment
Mimi Hu, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
|UT MD Anderson Cancer Center||Houston, Texas 77030|