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Acute Hip Fracture Study in Patients 65 Years or Greater

Primary Purpose

Hip Fractures

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VK5211
Placebo
Sponsored by
Viking Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Duurga Clinical Service
  • Orthopedic Research Institute
  • Infinite Clinical Research
  • Shrock Orthopedic Research, LLC
  • Center for Advanced Research & Education
  • Orthopaedic Association of Michigan
  • University of Wisconsin Osteoporosis Clinical Research Program
  • Szent János Kórház és Észak budai Egyesített Kórházak Traumatológiai és Kézsebészeti Osztály
  • MH Egészségügyi Központ Baleseti Sebészeti Osztály
  • Szent Margit Kórház, Mozgásszervi Rehabilitációs Osztály
  • Petz Aladár Megyei Oktató Kórház Mozgásszervi Rehabilitációs Osztály
  • Jósa András Oktató Kórház Traumatológiai és Kézsebészeti Osztály
  • SZTE ÁOK Traumatológiai Klinika
  • Spitalul Clinic de Urgenta Bucuresti ("Floreasca")
  • Spitalul Universitar de Urgenţă
  • Spitalul Clinic Judeţean de Urgenţe, Sfȃntul Spiridon
  • Institut za Ortopedsko-hirurške bolesti Banjica
  • Klinički Centar Srbije
  • Hospital Center "Bezanijska kosa" Department for Orthopedic Surgery and Traumatology
  • Clinical Center Kragujevac Department for Orthopedics and Traumatology
  • Clinical Centre of Vojvodina Department for Orthopedic Surgery and Traumatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

VK5211- 0.5mg

VK5211- 1.0mg

VK5211- 2.0mg

Arm Description

Placebo QD

0.5mgQD

1.0mg QD

2.0mg QD

Outcomes

Primary Outcome Measures

Efficacy in hip fracture patients confirmed by DXA scan.

Secondary Outcome Measures

Full Information

First Posted
October 13, 2015
Last Updated
April 22, 2021
Sponsor
Viking Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02578095
Brief Title
Acute Hip Fracture Study in Patients 65 Years or Greater
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 30, 2015 (Actual)
Primary Completion Date
November 15, 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viking Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo QD
Arm Title
VK5211- 0.5mg
Arm Type
Experimental
Arm Description
0.5mgQD
Arm Title
VK5211- 1.0mg
Arm Type
Experimental
Arm Description
1.0mg QD
Arm Title
VK5211- 2.0mg
Arm Type
Experimental
Arm Description
2.0mg QD
Intervention Type
Drug
Intervention Name(s)
VK5211
Intervention Description
Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule
Primary Outcome Measure Information:
Title
Efficacy in hip fracture patients confirmed by DXA scan.
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Mancini
Organizational Affiliation
Viking Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Duurga Clinical Service
City
Yorba Linda
State/Province
California
ZIP/Postal Code
92886
Country
United States
Facility Name
Orthopedic Research Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Infinite Clinical Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Shrock Orthopedic Research, LLC
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Center for Advanced Research & Education
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Orthopaedic Association of Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
University of Wisconsin Osteoporosis Clinical Research Program
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Szent János Kórház és Észak budai Egyesített Kórházak Traumatológiai és Kézsebészeti Osztály
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
MH Egészségügyi Központ Baleseti Sebészeti Osztály
City
Budapest
Country
Hungary
Facility Name
Szent Margit Kórház, Mozgásszervi Rehabilitációs Osztály
City
Budapest
Country
Hungary
Facility Name
Petz Aladár Megyei Oktató Kórház Mozgásszervi Rehabilitációs Osztály
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Jósa András Oktató Kórház Traumatológiai és Kézsebészeti Osztály
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
SZTE ÁOK Traumatológiai Klinika
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Spitalul Clinic de Urgenta Bucuresti ("Floreasca")
City
Bucuresti
ZIP/Postal Code
014461
Country
Romania
Facility Name
Spitalul Universitar de Urgenţă
City
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Facility Name
Spitalul Clinic Judeţean de Urgenţe, Sfȃntul Spiridon
City
Iaşi
ZIP/Postal Code
700111
Country
Romania
Facility Name
Institut za Ortopedsko-hirurške bolesti Banjica
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Klinički Centar Srbije
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Hospital Center "Bezanijska kosa" Department for Orthopedic Surgery and Traumatology
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Kragujevac Department for Orthopedics and Traumatology
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Centre of Vojvodina Department for Orthopedic Surgery and Traumatology
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia

12. IPD Sharing Statement

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Acute Hip Fracture Study in Patients 65 Years or Greater

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