A Phase IIa Study Of Men And Post-Menopausal Women With A Fractured Distal Radius

Summary

This is a study designed to test the safety and effectiveness of SB-751689 in the treatment of a distal radius fracture in post-menopausal women and men in comparison to placebo to determine if healing time of the fracture can be decreased.

Timeline

Start

2007-09-20

Primary completion

2008-11-26

Completion

2008-11-26

Outcome

Missed primary endpoint

Stopped: “Lack of efficacy”

paper Ronacaleret, a calcium-sensing receptor antagonist, has no significant effect on radial fracture healing time PMID 21742071 ↗

paper There were no significant differences between treatment groups in time to radiographic fracture healing PMID 21742071 ↗

Publications

• Fitzpatrick LA, Smith PL, McBride TA, Fries MA, Hossain M, Dabrowski CE, Gordon DN. Ronacaleret, a calcium-sensing receptor antagonist, has no significant effect on radial fracture healing time: results of a randomized, double-blinded, placebo-controlled Phase II clinical trial. Bone. 2011 Oct;49(4):845-52. doi: 10.1016/j.bone.2011.06.017. Epub 2011 Jun 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SB-751689	Unknown	200 mg	Oral
Subject	SB-751689	Unknown	400 mg	Oral

Indications

No indication recorded.