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

Osteoporosis Clinical Trial

— Probono1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669954
• Other study ID #: RJ1 09/0329
• Secondary ID: 08/H0805/56
• Status: Completed
• Phase: N/A
• First received: August 13, 2012
• Last updated: August 17, 2012
• Start date: February 2009
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Fractures
• HIV Infection
• HIV Infections
• Osteoporosis

Locations

Country	Name	City	State
United Kingdom	St Thomas, Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	St Thomas' Hospital, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density at Hip	Bone mineral density as determined by DXA scanning	The outcome is measured within 6 months (0-6 months) after entry to the study.	No
Secondary	Bone mineral density at spine (L4)	As determined by DXA scan	The outcome is measured within 6 months (0-6 months) after entry to the study.	No
Secondary	Any lifetime fractures reported by subjects	Self-reported fractures of any type	At any stage during persons life up to and including the last visit for the volunteer to the study.	No
Secondary	Vitamin D levels	Plasma vitamin D	The outcome is measured within 6 months (0-6 months) after entry to the study.	No