Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Prostate Cancer

What Was Tested

In this not phased trial, researchers set out to test Goserelin for osteoporosis and bone density.

The aim of this study is to determine the long term effects of two types of hormonal treatment for advanced prostate cancer (LHRH agonists and the antiandrogen bicalutamide)on the bone mineral density of patients.

It had three arms (groups): Osteporosis Group (active comparator), Osteopenia Group (active comparator) and Normal Group (active comparator).

Patients with a presenting T score \< -2.5 (osteoporosis), treated with bicalutamide and Ca/VitD.

Patients with a presenting T score between -1.0 and -2,4 (osteopenia), treated with LHRH agonists and Ca/VitD.

Patients with a presenting T score \> -1.0(normal BMD), treated with LHRH agonists.

The registry classes the interventions as drug.

More on the Plan

Androgen ablation is the mainstay of treatment for advanced prostate cancer.

An alternative is the non steroidal antiandrogen, bicalutamide, which acts at the androgen receptor and maintains serum testosterone levels.

Their aim was to assess the effects of these two treatments on bone mineral density (BMD) of selected groups of patients, based on their BMD at presentation.

All patients will undergo peripheral bone densitometry of the forearm, using dual energy X-ray absorptiometry.

Who Took Part

Enrollment: 618 actual participants took part.

It was open to men only.

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

Examples of who could join: Patients will locally advanced prostate cancer for whom immediate androgen deprivation was indicated.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: previous systemic therapy for prostate cancer; patients with any illness or medication that would affect bone and mineral metabolism; severe hepatic or renal insufficiency.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

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

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

It started in 1999-10 with completion listed for 2007-01.

It ran at 1 site in United Kingdom.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Peripheral Forearm bone mineral density (time frame: Over 7 years).

It also tracked 1 secondary outcome, for example Fractures of the thoracolumbar spine.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Goserelin in 618 people with osteoporosis and bone density.

With 618 participants it is a large trial for this field.

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

More context: the Goserelin compound page, Osteoporosis and bone density research.