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

What Was Tested

The trial (phase 2) is built around Teriparatide.

It had four arms (groups): Calcium + Calcitriol (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

7 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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).

The full record lists 2 inclusion and 17 exclusion criteria; among the exclusions: patients who have jejunal tubes; patients \<18 years old; treatment with teriparatide or calcitriol (rocaltrol) within 1 month prior to surgery.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.

The Teriparatide group and the comparison group ran side by side rather than switching.

Being open-label, the Teriparatide study did not mask who received what.

It started in 2008-05 with completion listed for 2010-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Patients With Success (time frame: 2 - 7 days post-treatment).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 7 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Teriparatide compound page, all human trials.