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Clinical Trial NCT02578095 for Hip Fractures is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Viking Therapeutics, Inc.Acute Hip Fracture Study in Patients 65 Years or Greater Phase 2 108 Randomized Double-Blind Placebo-Controlled
Clinical Trial NCT02578095 was designed to study Treatment for Hip Fractures. This was a Phase 2 interventional study that is now completed. The study started on October 30, 2015, with plans to enroll 108 participants. Led by Viking Therapeutics, Inc., the expected completion date was December 17, 2017. The latest data from ClinicalTrials.gov was last updated on December 29, 2025.
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.
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
Conditions
Hip FracturesOther Study IDs
- VK5211-201
NCT ID Number
Start Date (Actual)
2015-10-30
Last Update Posted
2025-12-29
Completion Date (Estimated)
2017-12-17
Enrollment (Estimated)
108
Study Type
Interventional
PHASE
Phase 2
Status
Completed
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Placebo ComparatorPlacebo Placebo QD | Placebo Capsule |
ExperimentalVK5211- 0.5mg 0.5mgQD | VK5211 Capsule |
ExperimentalVK5211- 1.0mg 1.0mg QD | VK5211 Capsule |
ExperimentalVK5211- 2.0mg 2.0mg QD | VK5211 Capsule |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Efficacy in Hip Fracture Patients Confirmed by DXA Scan. | Efficacy of VK5211 after 12 weeks of treatment by mean placebo-corrected percentage change in total body less head (TBLH) lean body mass assessed by whole body dual-energy x-ray absorptiometry scan (DXA) scan. | Baseline and Week12 |
Eligibility Criteria
Eligible Ages
Older Adult
Minimum Age
65 Years
Eligible Sexes
All
- 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.
- 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.
Viking Therapeutics, Inc.No contact data.
21 Study Locations in 4 Countries
Spitalul Clinic de Urgenta Bucuresti ("Floreasca"), Bucharest, 014461, Romania
Spitalul Universitar de Urgenţă, Bucharest, 050098, Romania
Spitalul Clinic Judeţean de Urgenţe, Sfȃntul Spiridon, Iași, 700111, Romania
Szent János Kórház és Észak budai Egyesített Kórházak Traumatológiai és Kézsebészeti Osztály, Budapest, 1125, Hungary
MH Egészségügyi Központ Baleseti Sebészeti Osztály, Budapest, Hungary
Szent Margit Kórház, Mozgásszervi Rehabilitációs Osztály, Budapest, Hungary
Petz Aladár Megyei Oktató Kórház Mozgásszervi Rehabilitációs Osztály, Győr, 9024, Hungary
Jósa András Oktató Kórház Traumatológiai és Kézsebészeti Osztály, Nyíregyháza, 4400, Hungary
SZTE ÁOK Traumatológiai Klinika, Szeged, 6725, Hungary
Institut za Ortopedsko-hirurške bolesti Banjica, Belgrade, 11000, Serbia
Klinički Centar Srbije, Belgrade, 11000, Serbia
Hospital Center "Bezanijska kosa" Department for Orthopedic Surgery and Traumatology, Belgrade, 11080, Serbia
Clinical Center Kragujevac Department for Orthopedics and Traumatology, Kragujevac, 34000, Serbia
Clinical Centre of Vojvodina Department for Orthopedic Surgery and Traumatology, Novi Sad, 21000, Serbia
California
Duurga Clinical Service, Yorba Linda, California, 92886, United States
Florida
Orthopedic Research Institute, Boynton Beach, Florida, 33472, United States
Infinite Clinical Research, Doral, Florida, 33126, United States
Shrock Orthopedic Research, LLC, Fort Lauderdale, Florida, 33136, United States
Georgia
Center for Advanced Research & Education, Gainesville, Georgia, 30501, United States
Michigan
Orthopaedic Association of Michigan, Grand Rapids, Michigan, 49525, United States
Wisconsin
University of Wisconsin Osteoporosis Clinical Research Program, Madison, Wisconsin, 53705, United States