Determination of Optimum Age for DXA Screening for Osteoporosis in HIV - The Probono 1 Study

NCT ID: NCT01669954

Last Updated: 2012-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

440 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study is to determine the bone mineral density in male and female patients with HIV infection according to age groups.

This will enable a practical approach to screening for osteoporosis and the management and prevention of fragility fractures in people with HIV.

In addition, all risk factors commonly associated with fragility fractures and osteoporosis are collected, as is HIV drug history.

Hence, as secondary outcomes, the associations with reduced bone mineral density can be ascertained.

Detailed Description

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Conditions

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Osteoporosis Fractures HIV Infection

Keywords

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HIV Bone mineral density Osteoporosis Vitamin D Fractures

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Controls, females

Controls who are presumed HIV uninfected, females, aged 18 or above

No interventions assigned to this group

Controls, males

Controls presumed HIV uninfected, males, aged 18 or above

No interventions assigned to this group

HIV infected patients, males

HIV patients, males, aged 18 or above

No interventions assigned to this group

HIV patients,

HIV patients, females, aged 18 or above

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18 years or above Not pregnant Able to comply with study observations and procedures Able to give fully informed consent

Exclusion Criteria

* Pregnant Less than 18 years of age Unable to comply with study procedures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St Thomas' Hospital, London

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Barry Stephen Peters

Reader and Consultant HIV Medicine, Head of Research Unit, Principle Investigator, Clinical Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barry S Peters, MD PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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St Thomas, Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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08/H0805/56

Identifier Type: OTHER

Identifier Source: secondary_id

RJ1 09/0329

Identifier Type: -

Identifier Source: org_study_id