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Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort

Primary Purpose

HIV Infections

Status
Withdrawn
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Ibandronate
Lifestyle modifications
Sponsored by
Germans Trias i Pujol Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring osteoporosis, bifosfonates, ibandronate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years old or elder.
  2. Documented HIV-1 infection, with or without antiretroviral treatment.
  3. 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)
  4. Willing to follow the study protocol.
  5. Informed Consent signature.

Exclusion Criteria:

  1. In women, pregnancy or breastfeeding.
  2. Other possible causes of secondary osteoporosis.
  3. Creatinin over 2.3mg/mL
  4. Glomerular filter less than 50 mL/min (estimated through MDRD)
  5. Alendronate treatment in the last 6 months.

Sites / Locations

  • Germans Trias i Pujol Hospital - Lluita Sida Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

Ibandronate + Lifestyle modifications

Lifestyle modifications

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse events
Lab tests
Related clinical events (bone fractures)
Osteoblastic/Osteoclastic activity, bone formation/reabsorption.

Full Information

First Posted
April 17, 2008
Last Updated
March 12, 2019
Sponsor
Germans Trias i Pujol Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00662077
Brief Title
Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort
Official Title
Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Financial difficulties
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Germans Trias i Pujol Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The lower bone mineral density that has been described in patients with HIV-infection has not meant an increase of long term complications. Nevertheless, it could involve an increase if the associated co-mordibity in the future, taking in care that in general population osteoporosis increases 4 times the pathologic fracture risk. That's why it is necessary to know the real prevalence of osteoporosis in this population of patients so the real dimensions of the problems can be defined. 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 been already proved. If the quarterly use of endovenous ibandronate obtains equivalent results to those obtained with oral and weekly alendronate in other studies with the same population, its use would be justified because of its posology benefits. The monthly or quarterly administration can improve compliance in patients who are recieving a big quantity of drugs, as HIV infected patients do and who probably have to be treated for life. Moreover, its elimination is renal so there is absence of interactions with antiretroviral drugs what mades of ibandronate a very promising alternative. Finally, there's no risk of digestive intolerance because of its parenteral administration and it has a better posology than oral bifosfonates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
osteoporosis, bifosfonates, ibandronate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Ibandronate + Lifestyle modifications
Arm Title
2
Arm Type
Other
Arm Description
Lifestyle modifications
Intervention Type
Drug
Intervention Name(s)
Ibandronate
Intervention Description
Ibandronate endovenous 3 mg every 3 months
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modifications
Intervention Description
Lifestyle modifications: counseling every 3 months
Primary Outcome Measure Information:
Title
Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density
Time Frame
BL, W24, W48, W72, W96
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
BL, W12, W24, W36, W48, W60, W72, W80, W96
Title
Lab tests
Time Frame
BL, W12, W24, W36, W48, W60, W72, W80, W96
Title
Related clinical events (bone fractures)
Time Frame
BL, W12, W24, W36, W48, W60, W72, W80, W96
Title
Osteoblastic/Osteoclastic activity, bone formation/reabsorption.
Time Frame
BL, W12, W24, W36, W48, W60, W72, W80, W96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugenia Negredo, MD,PhD
Organizational Affiliation
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Germans Trias i Pujol Hospital - Lluita Sida Foundation
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain

12. IPD Sharing Statement

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Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort

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