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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.
 
ClinicalTrials.gov Identifier: NCT02578095
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : November 7, 2019
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 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
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
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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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Information from the National Library of Medicine

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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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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    
Other Study ID Numbers: VK5211-201
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
 Femoral Fractures
Hip Injuries
Leg Injuries