Trial | NCT02578095  Report issue

Title

Acute Hip Fracture Study in Patients 65 Years or Greater
A Phase II, Randomized, Double-Blind, Parallel Group, Placebo- Controlled, Multi-Center Study to Explore the Efficacy, Safety and Tolerability of VK5211 in Subjects With Acute Hip Fracture

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    lgd-4033 ...

  • Study Participants

    108
This is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to investigate the safety, tolerability, and efficacy of VK5211 after 12 weeks of treatment.

Males and females ≥65 years old who are ambulatory and recovering from a hip fracture will be eligible for participation 3-7 weeks post-injury.
Study Started
Oct 30
2015
Primary Completion
Nov 15
2017
Study Completion
Mar 31
2018
Last Update
Apr 26
2021

Drug VK5211

Capsule

Drug Placebo

Capsule

Placebo Placebo Comparator

Placebo QD

VK5211- 0.5mg Experimental

0.5mgQD

VK5211- 1.0mg Experimental

1.0mg QD

VK5211- 2.0mg Experimental

2.0mg QD

Criteria 

Inclusion Criteria:

Males or females ≥65 years old who are recovering from a hip fracture (occurring 3-7 weeks prior) with no residual surgical issues will be eligible for participation.

Exclusion Criteria:

Pathological fracture (e.g. fracture due to Paget's disease of bone, malignancy, etc.). Fracture due to postmenopausal osteoporosis is not considered pathological for this trial.
No Results Posted