Clinical trial NCT02578095: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hip Fractures
Lead sponsor: Viking Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-16
Enrollment: 108
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Efficacy in hip fracture patients confirmed by DXA scan.
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Yorba Linda
country: United States
facility: Duurga Clinical Service
state: California
city: Boynton Beach
country: United States
facility: Orthopedic Research Institute
state: Florida
city: Doral
country: United States
facility: Infinite Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Shrock Orthopedic Research, LLC
state: Florida
city: Gainesville
country: United States
facility: Center for Advanced Research & Education
state: Georgia
city: Grand Rapids
country: United States
facility: Orthopaedic Association of Michigan
state: Michigan
city: Madison
country: United States
facility: University of Wisconsin Osteoporosis Clinical Research Program
state: Wisconsin
city: Budapest
country: Hungary
facility: Szent János Kórház és Észak budai Egyesített Kórházak Traumatológiai és Kézsebészeti Osztály
city: Budapest
country: Hungary
facility: MH Egészségügyi Központ Baleseti Sebészeti Osztály
city: Budapest
country: Hungary
facility: Szent Margit Kórház, Mozgásszervi Rehabilitációs Osztály
city: Gyor
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház Mozgásszervi Rehabilitációs Osztály
city: Nyíregyháza
country: Hungary
facility: Jósa András Oktató Kórház Traumatológiai és Kézsebészeti Osztály
city: Szeged
country: Hungary
facility: SZTE ÁOK Traumatológiai Klinika
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Urgenta Bucuresti ("Floreasca")
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenţă
city: Iaşi
country: Romania
facility: Spitalul Clinic Judeţean de Urgenţe, Sfȃntul Spiridon
city: Belgrade
country: Serbia
facility: Institut za Ortopedsko-hirurške bolesti Banjica
city: Belgrade
country: Serbia
facility: Klinički Centar Srbije
city: Belgrade
country: Serbia
facility: Hospital Center "Bezanijska kosa" Department for Orthopedic Surgery and Traumatology
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac Department for Orthopedics and Traumatology
city: Novi Sad
country: Serbia
facility: Clinical Centre of Vojvodina Department for Orthopedic Surgery and Traumatology
Study officials:
affiliation: Viking Therapeutics, Inc.
name: Marianne Mancini
role: STUDY_DIRECTOR
References: