Determination of Optimum Age for DXA Screening for Osteop... | NCT01669954

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

NCT01669954

Sponsor

King's College London

Status

Completed

Last Update Posted

Aug 21, 2012Estimated

Enrollment

440Actual

Phase

Not provided

Conditions

Osteoporosis
Fractures
HIV Infection

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
08/H0805/56	Other Identifier	National Research Ethics Service

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

May 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Aug 13, 2012

First Submission Date that Met QC Criteria

Aug 17, 2012

First Posted Date

Aug 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2012

Last Update Posted Date

Aug 21, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Barry Stephen Peters, Reader and Consultant HIV Medicine, Head of Research Unit, Principle Investigator, Clinical Researcher, King's College LondonPrincipal Investigator

Lead Sponsor

King's College LondonOTHER

Collaborators

Name	Class
St Thomas' Hospital, London	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

440Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.
Any lifetime fractures reported by subjects	Self-reported fractures of any type

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barry S Peters, MD PhD	King's College London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Thomas, Hospital		London		SE30AA	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis
D050723	Fractures, Bone
D015658	HIV Infections

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided