Acute Hip Fracture Study in Patients 65 Years or Greater

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578095
• Other study ID #: VK5211-201
• Status: Completed
• Phase: Phase 2
• Start date: October 30, 2015
• Est. completion date: March 2018

Study information

• Verified date: April 2021
• Source: Viking Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2018
• Est. primary completion date: November 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Drug:
• VK5211
Capsule
• Placebo
Capsule

Locations

Country	Name	City	State
Hungary	MH Egészségügyi Központ Baleseti Sebészeti Osztály	Budapest
Hungary	Szent János Kórház és Észak budai Egyesített Kórházak Traumatológiai és Kézsebészeti Osztály	Budapest
Hungary	Szent Margit Kórház, Mozgásszervi Rehabilitációs Osztály	Budapest
Hungary	Petz Aladár Megyei Oktató Kórház Mozgásszervi Rehabilitációs Osztály	Gyor
Hungary	Jósa András Oktató Kórház Traumatológiai és Kézsebészeti Osztály	Nyíregyháza
Hungary	SZTE ÁOK Traumatológiai Klinika	Szeged
Romania	Spitalul Clinic de Urgenta Bucuresti ("Floreasca")	Bucuresti
Romania	Spitalul Universitar de Urgenta	Bucuresti
Romania	Spitalul Clinic Judetean de Urgente, Sf?ntul Spiridon	Iasi
Serbia	Hospital Center "Bezanijska kosa" Department for Orthopedic Surgery and Traumatology	Belgrade
Serbia	Institut za Ortopedsko-hirurške bolesti Banjica	Belgrade
Serbia	Klinicki Centar Srbije	Belgrade
Serbia	Clinical Center Kragujevac Department for Orthopedics and Traumatology	Kragujevac
Serbia	Clinical Centre of Vojvodina Department for Orthopedic Surgery and Traumatology	Novi Sad
United States	Orthopedic Research Institute	Boynton Beach	Florida
United States	Infinite Clinical Research	Doral	Florida
United States	Shrock Orthopedic Research, LLC	Fort Lauderdale	Florida
United States	Center for Advanced Research & Education	Gainesville	Georgia
United States	Orthopaedic Association of Michigan	Grand Rapids	Michigan
United States	University of Wisconsin Osteoporosis Clinical Research Program	Madison	Wisconsin
United States	Duurga Clinical Service	Yorba Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Viking Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Hungary,  Romania,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy in hip fracture patients confirmed by DXA scan.		12 Weeks