NCT00795483

Brief Summary

The purpose of this project is to determine the incidence of osteoporosis in the investigators' population of HIV-infected patients and to assess the efficacy and security of zoledronic acid, whose efficacy in post-menopausal women with high fracture risk treatment and in Paget's disease treatment has already been demonstrated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2008

Completed
12 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

January 31, 2020

Status Verified

August 1, 2012

Enrollment Period

2 years

First QC Date

November 20, 2008

Last Update Submit

January 30, 2020

Conditions

HIV Infections

Keywords

OsteoporosisHIV infectionBisphosphonatesZoledronic acid

Outcome Measures

Primary Outcomes (2)

  • Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density

    Evolution from baseline to week 48

  • Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density

    Evolution from baseline to week 96

Secondary Outcomes (5)

  • Adverse events

    From baseline to week 96

  • Lab tests

    Evolution from baseline to week 96

  • Related clinical events (bone fractures)

    From baseline to week 96

  • Osteoblastic/Osteoclastic activity, bone formation/reabsorption.

    Evolution from baseline to week 48

  • Osteoblastic/Osteoclastic activity, bone formation/reabsorption.

    Evolution from baseline to week 96

Study Arms (3)

1-ANNUAL

EXPERIMENTAL

1\. Zoledronic acid + Lifestyle modifications (experimental)

Drug: Zoledronic acidBehavioral: Lifestyle modifications

2-CONTROL

OTHER

2\. Lifestyle modifications (control)

Behavioral: Lifestyle modifications

3-BIENNIAL

EXPERIMENTAL

3\. Zoledronic acid + Lifestyle modifications (experimental)

Behavioral: Lifestyle modificationsDrug: Zoledronic acid

Interventions

Zoledronic acidDRUG

Zoledronic Acid 5mg/year

1-ANNUAL
Lifestyle modificationsBEHAVIORAL

Lifestyle modifications

1-ANNUAL2-CONTROL3-BIENNIAL

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or older.
  • Documented HIV-1 infection, with or without antiretroviral treatment.
  • Presence of WHO osteoporosis criteria, defined as t-score under -2.5 in lumbar, hip and/or trochanter (DEXA in the last 6 months is needed).
  • Willing to follow the study protocol.
  • Informed Consent signature.

You may not qualify if:

  • In women, pregnancy or breastfeeding.
  • Other possible causes of secondary osteoporosis.
  • Creatinine over 2.3 mg/mL.
  • Glomerular filter less than 50 mL/min (estimated through MDRD).
  • Treatment for Osteoporosis in the last 4 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

HIV InfectionsOsteoporosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Negredo Eugenia, MD,PhD

    LLuita contra la SIDA Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Eugenia Negredo

Study Record Dates

First Submitted

November 20, 2008

First Posted

November 21, 2008

Study Start

November 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

January 31, 2020

Record last verified: 2012-08

Locations

ES(1)