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

NCT01669954 | Completed

• 2 other identifiers: RJ1 09/032908/H0805/56
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Fractures; HIV Infection

Keywords

HIV; Bone mineral density; Osteoporosis; Vitamin D; Fractures

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• Bone mineral density at spine (L4)

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

• 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.

• Vitamin D levels

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

Study Arms (4)

Controls, females

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

Controls, males

Controls presumed HIV uninfected, males, aged 18 or above

HIV infected patients, males

HIV patients, males, aged 18 or above

HIV patients,

HIV patients, females, aged 18 or above

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A randomly recruited numbers of HIV uninfected controls and HIV patients aged 18 years or above, equally matched for age, and gender.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King's College London: lead
• St Thomas' Hospital, London: collaborator

Study Sites (1)

St Thomas, Hospital

London, SE30AA, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and urine

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone; HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Barry S Peters, MD PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader and Consultant HIV Medicine, Head of Research Unit, Principle Investigator, Clinical Researcher

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 21, 2012
• Study Start: February 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 21, 2012

Record last verified: 2012-08

Locations

GB (1)