Acute Hip Fracture Study in Patients 65 Years or Greater

Viking Therapeutics, Inc.108 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

108

Conditions

Hip Fractures

Interventions

VK5211DRUG

Capsule

PlaceboDRUG

Capsule

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (21)

Duurga Clinical Service

Yorba Linda, California, United States

Outcomes

Primary Outcomes

Efficacy in Hip Fracture Patients Confirmed by DXA Scan.

Efficacy of VK5211 after 12 weeks of treatment by mean placebo-corrected percentage change in total body less head (TBLH) lean body mass assessed by whole body dual-energy x-ray absorptiometry scan (DXA) scan.

Time frame: Baseline and Week12

Data from ClinicalTrials.gov

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