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

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 Overview

• Status: Completed
• Conditions: Hip Fractures
• Intervention / Treatment: Drug: Placebo; Drug: VK5211

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1125
    • Szent János Kórház és Észak budai Egyesített Kórházak Traumatológiai és Kézsebészeti Osztály
  • Budapest, Hungary
    • MH Egészségügyi Központ Baleseti Sebészeti Osztály
  • Budapest, Hungary
    • Szent Margit Kórház, Mozgásszervi Rehabilitációs Osztály
  • Gyor, Hungary, 9024
    • Petz Aladár Megyei Oktató Kórház Mozgásszervi Rehabilitációs Osztály
  • Nyíregyháza, Hungary, 4400
    • Jósa András Oktató Kórház Traumatológiai és Kézsebészeti Osztály
  • Szeged, Hungary, 6725
    • SZTE ÁOK Traumatológiai Klinika
• Romania
  • Bucuresti, Romania, 014461
    • Spitalul Clinic de Urgenta Bucuresti ("Floreasca")
  • Bucuresti, Romania, 050098
    • Spitalul Universitar de Urgenta
  • Iaşi, Romania, 700111
    • Spitalul Clinic Judeţean de Urgenţe, Sfȃntul Spiridon
• Serbia
  • Belgrade, Serbia, 11000
    • Klinicki Centar Srbije
  • Belgrade, Serbia, 11000
    • Institut za Ortopedsko-hirurške bolesti Banjica
  • Belgrade, Serbia, 11080
    • Hospital Center "Bezanijska kosa" Department for Orthopedic Surgery and Traumatology
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac Department for Orthopedics and Traumatology
  • Novi Sad, Serbia, 21000
    • Clinical Centre of Vojvodina Department for Orthopedic Surgery and Traumatology
• United States
  • California
    • Yorba Linda, California, United States, 92886
      • Duurga Clinical Service
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Orthopedic Research Institute
    • Doral, Florida, United States, 33126
      • Infinite Clinical Research
    • Fort Lauderdale, Florida, United States, 33136
      • Shrock Orthopedic Research, LLC
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Center for Advanced Research & Education
  • Michigan
    • Grand Rapids, Michigan, United States, 49525
      • Orthopaedic Association of Michigan
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin Osteoporosis Clinical Research Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo QD	Drug: Placebo; Capsule
Experimental: VK5211- 0.5mg; 0.5mgQD	Drug: VK5211; Capsule
Experimental: VK5211- 1.0mg; 1.0mg QD	Drug: VK5211; Capsule
Experimental: VK5211- 2.0mg; 2.0mg QD	Drug: VK5211; Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy in hip fracture patients confirmed by DXA scan.	12 Weeks

Collaborators and Investigators

• Sponsor: Viking Therapeutics, Inc.
• Investigators: Study Director: Marianne Mancini, Viking Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2015
• Primary Completion (Actual): November 15, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 15, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: VK5211-201