Treatment With PTH After Sternotomy in Cardiac Surgery Patients

What Was Tested

This registered phase 3 trial tested Parathyroid Hormone (PTH 1-84).

The aims of this study is to compare healing time and quality of newly formed bone in cardiac surgery patients treated with PTH post-surgically and a control group treated with saline.

It had two arms (groups): Control (placebo comparator) and Intervention (active comparator).

Control patients treated with placebo.

Daily injection with Parathyroid hormone.

The registry classes the interventions as drug.

More on the Plan

Heart surgery is most commonly performed through a central division of the sternum, a sternotomy.

This procedure provides full overview of the thoracic cavity and access to the organs within.

When closing the sternum, the normal procedure is to use steel wires to hold the two sternal halves together.

Parathyroid hormone (PTH) is a well known anabolic drug and has been used to treat osteoporosis in post-menopausal women with great effect.

Who Took Part

20 actual participants took part.

It was open to men only aged from 50 years with no upper age limit.

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

Examples of who could join: Not in chronic, systemic corticosteroid treatment. No Plavix treatment 5 days prior to surgery. No known bone metabolic diseases. Normal serum levels of Calcium, Phosphate, inorganic, alkaline phosphatase (within reference interval). No known risk of osteosarcoma.

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: use of bone wax during surgery; prior radiation therapy involving the skeleton; severely impaired renal function.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Parathyroid Hormone (PTH 1-84) group and the comparison group should start out alike.

The Parathyroid Hormone (PTH 1-84) group and the comparison group ran side by side rather than switching.

As a double-blind Parathyroid Hormone (PTH 1-84) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2012-10 with completion listed for 2014-03.

It ran at 1 site in Denmark.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Computer Tomography (time frame: 6 weeks (± 1 week), 3 months (± 2 weeks) and 6 months (± 2 weeks)).

It also tracked 2 secondary outcomes, for example Questionnaires and Journal parameters.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Parathyroid Hormone (PTH 1-84) in 20 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Parathyroid Hormone (PTH 1-84) compound page, all human trials.