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Acute Hip Fracture Study in Patients 65 Years or Greater

NCT ID: NCT02578095

Last Updated: 2025-12-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-30

Study Completion Date

2017-12-17

Brief Summary

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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

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Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo QD

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsule

VK5211- 0.5mg

0.5mgQD

Group Type EXPERIMENTAL

VK5211

Intervention Type DRUG

Capsule

VK5211- 1.0mg

1.0mg QD

Group Type EXPERIMENTAL

VK5211

Intervention Type DRUG

Capsule

VK5211- 2.0mg

2.0mg QD

Group Type EXPERIMENTAL

VK5211

Intervention Type DRUG

Capsule

Interventions

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VK5211

Capsule

Intervention Type DRUG

Placebo

Capsule

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Viking Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marianne Mancini

Role: STUDY_DIRECTOR

Viking Therapeutics, Inc.

Locations

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Duurga Clinical Service

Yorba Linda, California, United States

Site Status

Orthopedic Research Institute

Boynton Beach, Florida, United States

Site Status

Infinite Clinical Research

Doral, Florida, United States

Site Status

Shrock Orthopedic Research, LLC

Fort Lauderdale, Florida, United States

Site Status

Center for Advanced Research & Education

Gainesville, Georgia, United States

Site Status

Orthopaedic Association of Michigan

Grand Rapids, Michigan, United States

Site Status

University of Wisconsin Osteoporosis Clinical Research Program

Madison, Wisconsin, United States

Site Status

Szent János Kórház és Észak budai Egyesített Kórházak Traumatológiai és Kézsebészeti Osztály

Budapest, , Hungary

Site Status

MH Egészségügyi Központ Baleseti Sebészeti Osztály

Budapest, , Hungary

Site Status

Szent Margit Kórház, Mozgásszervi Rehabilitációs Osztály

Budapest, , Hungary

Site Status

Petz Aladár Megyei Oktató Kórház Mozgásszervi Rehabilitációs Osztály

Győr, , Hungary

Site Status

Jósa András Oktató Kórház Traumatológiai és Kézsebészeti Osztály

Nyíregyháza, , Hungary

Site Status

SZTE ÁOK Traumatológiai Klinika

Szeged, , Hungary

Site Status

Spitalul Clinic de Urgenta Bucuresti ("Floreasca")

Bucharest, , Romania

Site Status

Spitalul Universitar de Urgenţă

Bucharest, , Romania

Site Status

Spitalul Clinic Judeţean de Urgenţe, Sfȃntul Spiridon

Iași, , Romania

Site Status

Institut za Ortopedsko-hirurške bolesti Banjica

Belgrade, , Serbia

Site Status

Klinički Centar Srbije

Belgrade, , Serbia

Site Status

Hospital Center "Bezanijska kosa" Department for Orthopedic Surgery and Traumatology

Belgrade, , Serbia

Site Status

Clinical Center Kragujevac Department for Orthopedics and Traumatology

Kragujevac, , Serbia

Site Status

Clinical Centre of Vojvodina Department for Orthopedic Surgery and Traumatology

Novi Sad, , Serbia

Site Status

Countries

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United States Hungary Romania Serbia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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VK5211-201

Identifier Type: -

Identifier Source: org_study_id