Acute Hip Fracture Study in Patients 65 Years or Greater
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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 : April 26, 2021
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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 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 |

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 |
- Efficacy in hip fracture patients confirmed by DXA scan. [ Time Frame: 12 Weeks ]

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 (Older Adult) |
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.

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

Study Director: | Marianne Mancini | Viking Therapeutics, Inc. |
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: | April 26, 2021 |
Last Verified: | April 2021 |
Fractures, Bone Hip Fractures Wounds and Injuries |
Femoral Fractures Hip Injuries Leg Injuries |