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Trial record 1 of 1 for:    VK5211
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Acute Hip Fracture Study in Patients 65 Years or Greater

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02578095
First Posted: October 16, 2015
Last Update Posted: August 11, 2017
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.
Information provided by (Responsible Party):
Viking Therapeutics, Inc.
  Purpose

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 Intervention Phase
Hip Fractures Drug: VK5211 Drug: Placebo for VK5211 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Viking Therapeutics, Inc.:

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

Enrollment: 108
Study Start Date: October 2015
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
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
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
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
Klinički Centar Srbije
Belgrade, Serbia, 11000
Institut za Ortopedsko-hirurške bolesti Banjica
Beograd, Serbia, 11000
Hospital Center "Bezanijska kosa" Department for Orthopedic Surgery and Traumatology
Beograd, 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
Study Director: Marianne Mancini Viking Therapeutics, Inc.
  More Information

Responsible Party: Viking Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02578095     History of Changes
Other Study ID Numbers: VK5211-201
First Submitted: October 13, 2015
First Posted: October 16, 2015
Last Update Posted: August 11, 2017
Last Verified: August 2017

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