HIV UPBEAT: Understanding the Pathology of Bone Disease i... | NCT01778361

Studies
HIV UPBEAT: Understanding the Pathology of Bone Disease in HIV-infected Patients.

NCT01778361

Sponsor

University College Dublin

Status

Unknown status

Last Update Posted

Sep 25, 2019Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Osteoporosis

Interventions

Not provided

Countries

Ireland

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

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Jan 25, 2013

First Submission Date that Met QC Criteria

Jan 25, 2013

First Posted Date

Jan 29, 2013Estimated

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

Sep 24, 2019

Last Update Posted Date

Sep 25, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patrick Mallon, Associate Dean of Post-graduate Research, School of Medicine and Medical Sciences, Head of HIV Molecular Research Group, Consultant Infectious Diseases., University College DublinPrincipal Investigator

Lead Sponsor

University College DublinOTHER

Collaborators

Name	Class
Health Research Board, Ireland	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

Despite the prevalence of osteopenia and osteoporosis in the HIV positive population, relatively little is known about the underlying pathology. This prospective cohort study aims to gain further understanding about a number of issues relating to low bone mineral density in HIV-infected subjects.

Detailed Description

This study will follow HIV positive and negative subjects annually for 5 years. The aims of this study include:

to describe the pathology underlying low bone mineral density
to assess the relationship between low bone mineral density and antiretroviral therapy exposure
to assess the relationship between low bone mineral density and vitamin D /PTH status and/or markers of bone metabolism
to assess the relationship between osteopenia and subsequent changes in bone mineral density and markers of bone metabolism
to assess the validity of the currently available fracture risk assessment tool in predicting fractures in HIV positive populations

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

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone pathology	To describe abnormalities in bone pathology in bone biopsies from HIV-infected subjects with low bone mineral density by comparing biopsy indices to reference ranges.	3 years

Secondary Outcomes

Measure	Description	Time Frame
Rates of change in bone mineral density	To determine rates of change in bone mineral density in HIV-positive patients compared to HIV-negative controls	3 years

Other Outcomes

Measure	Description	Time Frame
Fracture incidence	To assess the validity of currently available fracture risk assessment tools in predicting fracture risk in HIV-infected patients.	3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age >18 years
be able to provide written, informed consent
be able to attend the research centre in a fasting state and undergo DEXA scanning

Exclusion Criteria:

Subjects on bisphosphonate therapy at screening
Pregnant or breastfeeding female subjects
Subjects with a previous clinical history of primary hyperthyroidism or HIV negative subjects with elevated parathyroid hormone at screening
HIV-negative subjects with a prior history of osteoporosis

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

HIV positive patients and HIV negative subjects

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tara N mcGinty, MB BCh BAO	Contact			tara.mcginty@ucd.ie
Babu Sumesh	Contact			sumesh.babu@ucd.ie

Overall Officials

Name	Affiliation	Role
Patrick WG Mallon, MB BCh, BSc, PhD	HIV Molecular Research Group, University College Dublin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mater Misericordiae University Hospital	Recruiting	Dublin		D 7	Ireland

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis
D000163	Acquired Immunodeficiency Syndrome
D001851	Bone Diseases, Metabolic
D050723	Fractures, Bone

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

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