The antiosteoporotic efficacy of intravenous pamidronate in men with prostate carcinoma receiving combined androgen blockade: a double blind, randomized, placebo-controlled crossover study.

What Was Tested

This randomized controlled trial looks at Flutamide.

Who Took Part

The abstract describes 10 men taking part.

PubMed indexes the participants as older adults, men only.

Twenty-one consecutive men with metastatic prostate carcinoma who were receiving combined androgen blockade with a long-acting gonadotropin-releasing hormone agonist (gosarelin acetate) and an androgen antagonist (flutamide or bicalutamide) were evaluated at baseline and at 6 and 12 months after therapy.

Data on 10 men with localized prostate carcinoma who were treated with radiotherapy alone, over the same period, was collected for comparison studies.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and crossover study.

Random assignment meant chance, not the researchers, decided who got Flutamide and who got the comparison, which limits bias.

Neither the men nor the staff measuring them knew who was on Flutamide, so expectations could not easily colour the readings.

A placebo (an inactive look-alike) gave the Flutamide group a baseline to be compared against.

Each person switched between Flutamide and the comparison at some point, usually with a gap in between.

Lumbar-spine bone-mineral densities (BMDs) were measured by spinal quantitative computed tomography (QCT), femoral neck BMDs were measured by dual-energy X-ray absorptiometry (DXA), and markers of bone turnover were measured by noninvasive methods.

What Was Measured

Topics PubMed links to this paper include Androgen Antagonists, Antineoplastic Agents, Antineoplastic Agents, Hormonal, Bone Density, Diphosphonates, Flutamide and Goserelin.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Flutamide in 10 men.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Its findings take up roughly 7 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2001 (Cancer), a journal based in United States.

More context: all human trials.