Trial intelligence / Profile preview

Toremifene for Fracture Prevention in Prostate Cancer on ADT

NCT00129142Phase 3

Key facts

Status: Completed
Start: Oct 2003
Primary completion: Nov 2007
Countries: 2
Sponsor: GTx
Modality: Small Molecules

Drugs: toremifene
Conditions: osteoporosisbone fracture (Fx)

Overview

Phase 3, randomised, double-blind trial in osteoporosis and bone fracture (Fx) comparing Toremifene Citrate with Placebo (2 arms). Primary endpoint: Percentage of subjects with at least one new vertebral fracture at 24 months. Started Oct 2003; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Toremifene Citrate
Toremifene Citrate
Placebo
Placebo

Endpoints

Primary

Percentage of subjects with at least one new vertebral fracture24 months

Secondary

Percentage of subjects with at least one new or worsening vertebral fracture24 months
Percentage of subjects with a clinical fragility fracture24 months
Percent change from baseline in lumbar bone mineral density (BMD)24 months

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