Acute Hip Fracture Study in Patients 65 Years or Greater

Phase 2

Completed

• Conditions: Hip Fractures
• Interventions: Drug: Placebo; Drug: VK5211

• Registration Number: NCT02578095
• Lead Sponsor: Viking Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-16
• Study Start: 2015-10-30
• Primary Completion: 2017-11-15
• Study Completion: 2018-03
• Disposition First Submitted: 2019-10-03
• Disposition First Submitted QC: 2019-10-03
• Disposition First Posted: 2019-10-16
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo QD
VK5211- 0.5mg	VK5211	0.5mgQD
VK5211- 1.0mg	VK5211	1.0mg QD
VK5211- 2.0mg	VK5211	2.0mg QD

Primary Outcome Measures

Name	Time	Method
Efficacy in hip fracture patients confirmed by DXA scan.	12 Weeks

Trial Locations

Locations (21)

Infinite Clinical Research; 🇺🇸 Doral, Florida, United States

Jósa András Oktató Kórház Traumatológiai és Kézsebészeti Osztály; 🇭🇺 Nyíregyháza, Hungary

SZTE ÁOK Traumatológiai Klinika; 🇭🇺 Szeged, Hungary

Spitalul Universitar de Urgenţă; 🇷🇴 Bucuresti, Romania

Institut za Ortopedsko-hirurške bolesti Banjica; 🇷🇸 Belgrade, Serbia

Duurga Clinical Service; 🇺🇸 Yorba Linda, California, United States

Petz Aladár Megyei Oktató Kórház Mozgásszervi Rehabilitációs Osztály; 🇭🇺 Gyor, Hungary

Orthopaedic Association of Michigan; 🇺🇸 Grand Rapids, Michigan, United States

University of Wisconsin Osteoporosis Clinical Research Program; 🇺🇸 Madison, Wisconsin, United States

Shrock Orthopedic Research, LLC; 🇺🇸 Fort Lauderdale, Florida, United States

Orthopedic Research Institute; 🇺🇸 Boynton Beach, Florida, United States

Szent János Kórház és Észak budai Egyesített Kórházak Traumatológiai és Kézsebészeti Osztály; 🇭🇺 Budapest, Hungary

MH Egészségügyi Központ Baleseti Sebészeti Osztály; 🇭🇺 Budapest, Hungary

Center for Advanced Research & Education; 🇺🇸 Gainesville, Georgia, United States

Clinical Center Kragujevac Department for Orthopedics and Traumatology; 🇷🇸 Kragujevac, Serbia

Hospital Center "Bezanijska kosa" Department for Orthopedic Surgery and Traumatology; 🇷🇸 Belgrade, Serbia

Szent Margit Kórház, Mozgásszervi Rehabilitációs Osztály; 🇭🇺 Budapest, Hungary

Spitalul Clinic de Urgenta Bucuresti ("Floreasca"); 🇷🇴 Bucuresti, Romania

Spitalul Clinic Judeţean de Urgenţe, Sfȃntul Spiridon; 🇷🇴 Iaşi, Romania

Klinički Centar Srbije; 🇷🇸 Belgrade, Serbia

Clinical Centre of Vojvodina Department for Orthopedic Surgery and Traumatology; 🇷🇸 Novi Sad, Serbia