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Acute Hip Fracture Study in Patients 65 Years or Greater

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02578095
Recruitment Status : Active, not recruiting
First Posted : October 16, 2015
Last Update Posted : January 24, 2018
Information provided by (Responsible Party):
Viking Therapeutics, Inc.

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 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
Primary Completion Date : November 15, 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT02578095

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
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
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
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.
Study Director: Marianne Mancini Viking Therapeutics, Inc.

Responsible Party: Viking Therapeutics, Inc. Identifier: NCT02578095     History of Changes
Other Study ID Numbers: VK5211-201
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

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