Acute Hip Fracture Study in Patients 65 Years or Greater

Sponsor

Viking Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02578095

Collaborator

(none)

108

Enrollment

Locations

Arms

Actual Duration (Months)

5.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Fractures	Drug: VK5211 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 30, 2015

Actual Primary Completion Date :

Nov 15, 2017

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Efficacy in hip fracture patients confirmed by DXA scan. [12 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Viking Therapeutics, Inc.

Investigators

Study Director: Marianne Mancini, Viking Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Viking Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT02578095

Other Study ID Numbers:

VK5211-201

First Posted:

Oct 16, 2015

Last Update Posted:

Apr 26, 2021

Last Verified:

Apr 1, 2021

Additional relevant MeSH terms:

Fractures, Bone

Hip Fractures

Study Results

No Results Posted as of Apr 26, 2021