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Completed

NCT Number: NCT01669954

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

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.

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Key information

Conditions

Osteoporosis Blood-Borne Infections Bone Diseases Bone Diseases, Metabolic Communicable Diseases Fractures Fractures, Bone Genital Diseases HIV Infection HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Thomas, Hospital

London, SE30AA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Bone mineral density at Hip

    Time frame: The outcome is measured within 6 months (0-6 months) after entry to the study.

    Bone mineral density as determined by DXA scanning

Secondary outcomes

  1. Bone mineral density at spine (L4)

    Time frame: The outcome is measured within 6 months (0-6 months) after entry to the study.

    As determined by DXA scan

  2. Any lifetime fractures reported by subjects

    Time frame: 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

  3. Vitamin D levels

    Time frame: The outcome is measured within 6 months (0-6 months) after entry to the study.

    Plasma vitamin D

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • St Thomas' Hospital, London

Registry information

Official study title

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

Acronym: Probono1

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 21, 2012
Registry last updated
Aug 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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