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Efficacy And Security Of Annual And Biennial Zoledronic Acid For Osteoporosis Treatment In An HIV-Infected Patients' Cohort

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Zoledronic acid
Lifestyle modifications
Zoledronic acid
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, HIV infection, Bisphosphonates, Zoledronic acid

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years old or older.
  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. Creatinine over 2.3 mg/mL.
  4. Glomerular filter less than 50 mL/min (estimated through MDRD).
  5. Treatment for Osteoporosis in the last 4 months.

Sites / Locations

  • Germans Trias i Pujol Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Experimental

Arm Label

1-ANNUAL

2-CONTROL

3-BIENNIAL

Arm Description

1. Zoledronic acid + Lifestyle modifications (experimental)

2. Lifestyle modifications (control)

3. Zoledronic acid + Lifestyle modifications (experimental)

Outcomes

Primary Outcome Measures

Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density
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.
Osteoblastic/Osteoclastic activity, bone formation/reabsorption.

Full Information

First Posted
November 20, 2008
Last Updated
January 30, 2020
Sponsor
Germans Trias i Pujol Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00795483
Brief Title
Efficacy And Security Of Annual And Biennial Zoledronic Acid For Osteoporosis Treatment In An HIV-Infected Patients' Cohort
Official Title
Efficacy and Security of Annual and Biennial Zoledronic Acid for Osteoporosis Treatment in an HIV-infected Patients' Cohort
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

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
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.
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-morbidity in the future, taking in care that in general population osteoporosis increases 4 times the pathologic fracture risk. That is 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 zoledronic acid. If the annual use of endovenous zoledronic acid 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 annual administration can improve compliance in patients who are receiving 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 makes of zoledronic acid a very promising alternative. Finally, there is no risk of digestive intolerance because of its parenteral administration and it has a better posology than oral bisphosphonates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Osteoporosis, HIV infection, Bisphosphonates, Zoledronic acid

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1-ANNUAL
Arm Type
Experimental
Arm Description
1. Zoledronic acid + Lifestyle modifications (experimental)
Arm Title
2-CONTROL
Arm Type
Other
Arm Description
2. Lifestyle modifications (control)
Arm Title
3-BIENNIAL
Arm Type
Experimental
Arm Description
3. Zoledronic acid + Lifestyle modifications (experimental)
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Intervention Description
Zoledronic Acid 5mg/year
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modifications
Intervention Description
Lifestyle modifications
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Intervention Description
Zoledronic acid (5mg/2years)
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
Evolution from baseline to week 48
Title
Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density
Time Frame
Evolution from baseline to week 96
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
From baseline to week 96
Title
Lab tests
Time Frame
Evolution from baseline to week 96
Title
Related clinical events (bone fractures)
Time Frame
From baseline to week 96
Title
Osteoblastic/Osteoclastic activity, bone formation/reabsorption.
Time Frame
Evolution from baseline to week 48
Title
Osteoblastic/Osteoclastic activity, bone formation/reabsorption.
Time Frame
Evolution from baseline to week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Negredo Eugenia, MD,PhD
Organizational Affiliation
LLuita contra la SIDA Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Germans Trias i Pujol Hospital
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain

12. IPD Sharing Statement

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Efficacy And Security Of Annual And Biennial Zoledronic Acid For Osteoporosis Treatment In An HIV-Infected Patients' Cohort

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