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

Completed

• Conditions: HIV Infection; Fractures; Osteoporosis

• Registration Number: NCT01669954
• Lead Sponsor: King's College London

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2012-05
• Study Completion: 2012-06
• Status Verified: 2012-08
• Study First Submitted: 2012-08-13
• Study First Submitted QC: 2012-08-17
• Last Update Submitted: 2012-08-17
• Study First Posted: 2012-08-21
• Last Update Posted: 2012-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

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

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Exclusion Criteria

• Pregnant Less than 18 years of age Unable to comply with study procedures

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone mineral density at Hip	The outcome is measured within 6 months (0-6 months) after entry to the study.	Bone mineral density as determined by DXA scanning

Secondary Outcome Measures

Name	Time	Method
Bone mineral density at spine (L4)	The outcome is measured within 6 months (0-6 months) after entry to the study.	As determined by DXA scan
Any lifetime fractures reported by subjects	At any stage during persons life up to and including the last visit for the volunteer to the study.	Self-reported fractures of any type
Vitamin D levels	The outcome is measured within 6 months (0-6 months) after entry to the study.	Plasma vitamin D

Trial Locations

Locations (1)

St Thomas, Hospital; 🇬🇧 London, United Kingdom