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Acute Hip Fracture Study in Patients 65 Years or Greater

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ClinicalTrials.gov Identifier: NCT02578095
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Viking Therapeutics, Inc.

Study Description
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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 for VK5211 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : October 30, 2015
Actual Primary Completion Date : November 15, 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo (for VK5211)
Placebo QD
 Drug: Placebo for VK5211
Capsule
Experimental: Active VK5211- 0.5mg
0.5mgQD
 Drug: VK5211
Capsule
Other Name: Active
Experimental: Active VK5211- 1.0mg
1.0mg QD
 Drug: VK5211
Capsule
Other Name: Active
Experimental: Active VK5211- 2.0mg
2.0mg QD
 Drug: VK5211
Capsule
Other Name: Active


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy in hip fracture patients confirmed by DXA scan. [ Time Frame: 12 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578095


Locations
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United States, California
Duurga Clinical Service
Yorba Linda, California, United States, 92886
United States, Florida
Orthopedic Research Institute
Boynton Beach, Florida, United States, 33472
Infinite Clinical Research
Doral, Florida, United States, 33126
Shrock Orthopedic Research, LLC
Fort Lauderdale, Florida, United States, 33136
United States, Georgia
Center for Advanced Research & Education
Gainesville, Georgia, United States, 30501
United States, Michigan
Orthopaedic Association of Michigan
Grand Rapids, Michigan, United States, 49525
United States, Wisconsin
University of Wisconsin Osteoporosis Clinical Research Program
Madison, Wisconsin, United States, 53705
Hungary
Szent János Kórház és Észak budai Egyesített Kórházak Traumatológiai és Kézsebészeti Osztály
Budapest, Hungary, 1125
MH Egészségügyi Központ Baleseti Sebészeti Osztály
Budapest, Hungary
Szent Margit Kórház, Mozgásszervi Rehabilitációs Osztály
Budapest, Hungary
Petz Aladár Megyei Oktató Kórház Mozgásszervi Rehabilitációs Osztály
Gyor, Hungary, 9024
Jósa András Oktató Kórház Traumatológiai és Kézsebészeti Osztály
Nyíregyháza, Hungary, 4400
SZTE ÁOK Traumatológiai Klinika
Szeged, Hungary, 6725
Romania
Spitalul Clinic de Urgenta Bucuresti ("Floreasca")
Bucuresti, Romania, 014461
Spitalul Universitar de Urgenţă
Bucuresti, Romania, 050098
Spitalul Clinic Judeţean de Urgenţe, Sfȃntul Spiridon
Iaşi, Romania, 700111
Serbia
Institut za Ortopedsko-hirurške bolesti Banjica
Belgrade, Serbia, 11000
Klinički Centar Srbije
Belgrade, Serbia, 11000
Hospital Center "Bezanijska kosa" Department for Orthopedic Surgery and Traumatology
Belgrade, Serbia, 11080
Clinical Center Kragujevac Department for Orthopedics and Traumatology
Kragujevac, Serbia, 34000
Clinical Centre of Vojvodina Department for Orthopedic Surgery and Traumatology
Novi Sad, Serbia, 21000
Sponsors and Collaborators
Viking Therapeutics, Inc.
Investigators
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Study Director: Marianne Mancini Viking Therapeutics, Inc.
More Information
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Responsible Party: Viking Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02578095     History of Changes
Other Study ID Numbers: VK5211-201
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
 Femoral Fractures
Hip Injuries
Leg Injuries