NCT00662077

Brief Summary

This project wills to determine the incidence of osteoporosis in our population of HIV-infected patients and to assess the efficacy and security of ibandronate, whose efficacy in post-menopausal women has already been proved.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

April 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

First QC Date

April 17, 2008

Last Update Submit

March 12, 2019

Conditions

HIV Infections

Keywords

osteoporosisbifosfonatesibandronate

Outcome Measures

Primary Outcomes (1)

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

    BL, W24, W48, W72, W96

Secondary Outcomes (4)

  • Adverse events

    BL, W12, W24, W36, W48, W60, W72, W80, W96

  • Lab tests

    BL, W12, W24, W36, W48, W60, W72, W80, W96

  • Related clinical events (bone fractures)

    BL, W12, W24, W36, W48, W60, W72, W80, W96

  • Osteoblastic/Osteoclastic activity, bone formation/reabsorption.

    BL, W12, W24, W36, W48, W60, W72, W80, W96

Study Arms (2)

1

EXPERIMENTAL

Ibandronate + Lifestyle modifications

Drug: IbandronateBehavioral: Lifestyle modifications

2

OTHER

Lifestyle modifications

Behavioral: Lifestyle modifications

Interventions

IbandronateDRUG

Ibandronate endovenous 3 mg every 3 months

1
Lifestyle modificationsBEHAVIORAL

Lifestyle modifications: counseling every 3 months

12

Eligibility Criteria

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

You may qualify if:

  • years old or elder.
  • 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.
  • Creatinin over 2.3mg/mL
  • Glomerular filter less than 50 mL/min (estimated through MDRD)
  • Alendronate treatment in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Germans Trias i Pujol Hospital - Lluita Sida Foundation

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

HIV InfectionsOsteoporosis

Interventions

Ibandronic 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 Chemicals

Study Officials

  • Eugenia Negredo, MD,PhD

    Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

    PRINCIPAL INVESTIGATOR
0

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
Principal Investigator

Study Record Dates

First Submitted

April 17, 2008

First Posted

April 21, 2008

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations

ES(1)