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Efficacy and Security of Zoledronic Acid for Osteoporosis Treatment in an HIV-Infected Patients' Cohort
This study is currently recruiting participants.
Verified by Germans Trias i Pujol Hospital, November 2008
Sponsored by: Germans Trias i Pujol Hospital
Information provided by: Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier: NCT00795483
  Purpose

The purpose of this project is to determine the incidence of osteoporosis in our 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.


Condition Intervention Phase
HIV
Drug: Zoledronic acid
Behavioral: Lifestyle modifications
Phase IV

MedlinePlus related topics: AIDS Osteoporosis
Drug Information available for: Zoledronic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy and Security of Zoledronic Acid for Osteoporosis Treatment in an HIV-Infected Patients' Cohort

Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:
  • Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density [ Time Frame: BL, W48, W96 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: BL, W12, W24, W36, W48, W60, W72, W80, W96 ] [ Designated as safety issue: Yes ]
  • Lab tests [ Time Frame: BL, W12, W24, W36, W48, W60, W72, W80, W96 ] [ Designated as safety issue: Yes ]
  • Related clinical events (bone fractures) [ Time Frame: BL, W12, W24, W36, W48, W60, W72, W80, W96 ] [ Designated as safety issue: Yes ]
  • Osteoblastic/Osteoclastic activity, bone formation/reabsorption. [ Time Frame: BL, W48, W96 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2008
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
1. Zoledronic acid + Lifestyle modifications (experimental)
Drug: Zoledronic acid
Zoledronic Acid 5mg/year
Behavioral: Lifestyle modifications
Lifestyle modifications
2: No Intervention
2. Lifestyle modifications (control)
Behavioral: Lifestyle modifications
Lifestyle modifications

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 bifosfonates.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 4 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795483

Contacts
Contact: Negredo Eugenia, MD,PhD 93 465 78 97 enegredo@flsida.org

Locations
Spain, Barcelona
Germans Trias i Pujol Hospital Recruiting
Badalona, Barcelona, Spain, 08916
Principal Investigator: Negredo Eugenia, MD,PhD            
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Investigators
Principal Investigator: Negredo Eugenia, MD,PhD LLuita contra la SIDA Foundation
  More Information

Responsible Party: Lluita Sida Foundation ( Lluita Sida Foundation )
Study ID Numbers: VIH-ZOL
Study First Received: November 20, 2008
Last Updated: November 20, 2008
ClinicalTrials.gov Identifier: NCT00795483  
Health Authority: Spain: Ministry of Health

Keywords provided by Germans Trias i Pujol Hospital:
osteoporosis
HIV infection
bifosfonates
zoledronic acid

Study placed in the following topic categories:
Diphosphonates
Zoledronic acid
Musculoskeletal Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009