A randomized, double blind, placebo-controlled trial of alendronate treatment for fibrous dysplasia of bone.

ABSTRACT:

Context

Fibrous dysplasia (FD) is a rare skeletal disorder, resulting in deformity, fracture, functional impairment, and pain. Bisphosphonates have been advocated as a potential treatment.

Objective

To determine the efficacy of alendronate for treatment of FD.

Design

Two-year randomized, double-blind, placebo-controlled trial.

Setting

Clinical research center.

Patients

Forty subjects with polyostotic FD (24 adults, 16 children). Subjects were randomized and stratified by age.

Interventions

Study drug was administered over a 24 month period in 6 month cycles (6 months on, 6 months off). Alendronate dosing was stratified: 40 mg daily for subjects >50 kg, 20 mg for 30-50 kg, 10 mg for 20-30 kg.

Main outcome measures

Primary endpoints were bone

SUBMITTER: Boyce AM 

PROVIDER: S-EPMC4223439 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature