Acute Hip Fracture Study in Patients 65 Years or Greater

Viking Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hip Fractures

Treatments: Drug: VK5211; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02578095

VK5211-201

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo QD

Treatment:

Drug: Placebo

VK5211- 0.5mg

Experimental group

Description:

0.5mgQD

Treatment:

Drug: VK5211

VK5211- 1.0mg

Experimental group

Description:

1.0mg QD

Treatment:

Drug: VK5211

VK5211- 2.0mg

Experimental group

Description:

2.0mg QD

Treatment:

Drug: VK5211