NCT02131571

Brief Summary

Prospective cohort study to determine the prevalence of vertebral fractures in HIV infected patients older than 50 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 30, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

3.8 years

First QC Date

May 2, 2014

Last Update Submit

June 29, 2018

Conditions

Vertebral Fractures

Keywords

HIVbonefracturesvitamin Dbiomarkers

Outcome Measures

Primary Outcomes (1)

  • Prevalence of vertebral fractures in HIV patients older than 50 years

    To determine by lumbar and thoracic x ray the presence of vertebral fractures and the changes in vertebral form or size, according to Genant methods

    2 years

Secondary Outcomes (2)

  • Risk of vertebral alteration according to bone mineral density and serum biomarkers

    2 years

  • Vertebral alterations during follow up

    2 years

Study Arms (1)

HIV patients older than 50 years

HIV infected patients older than 50 years in current follow up

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV infected patients older than 50 years

You may qualify if:

  • Age above 50 years
  • HIV infection

You may not qualify if:

  • Pregnancy
  • Receiving corticosteroids or antiresorptive therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramon y Cajal Hospital

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Spinal FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and Injuries

Study Officials

  • Jose L Casado, MD

    Ramon y Cajal Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2014

First Posted

May 6, 2014

Study Start

June 30, 2014

Primary Completion

March 30, 2018

Study Completion

June 15, 2018

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations

ES(1)