Completed

Probono1Prospective Study to Determine the Optimum Age for Routine DEXA Screening for Osteopenia/Osteoporosis in People With HIV Infection

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
No DNA Sample
Who is being recruted

Blood-Borne Infections+19

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: February 2009
See protocol details

Summary

Principal SponsorKing's College London
Last updated: August 21, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2009

Actual date on which the first participant was enrolled.

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.

NCT01669954
Principal SponsorKing's College London
Last updated: August 21, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

440 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBone DiseasesBone Diseases, MetabolicCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMetabolic DiseasesMusculoskeletal DiseasesNutritional and Metabolic DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesWounds and InjuriesSexually Transmitted Diseases, ViralLentivirus InfectionsOsteoporosisHIV InfectionsFractures, Bone

Criteria

1 inclusion criteria required to participate
18 years or above Not pregnant Able to comply with study observations and procedures Able to give fully informed consent
1 exclusion criteria prevent from participating
Pregnant Less than 18 years of age Unable to comply with study procedures

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

St Thomas, Hospital

London, United KingdomOpen St Thomas, Hospital in Google Maps
CompletedOne Study Center