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NCT02578095 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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