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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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ClinicalTrials.gov Identifier: NCT00795483
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : August 9, 2012
Sponsor:
Information provided by (Responsible Party):
Dra. EUGENIA NEGREDO PUIGMAL, Germans Trias i Pujol Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Zoledronic acid Behavioral: Lifestyle modifications Phase 4

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Security of Annual and Biennial Zoledronic Acid for Osteoporosis Treatment in an HIV-infected Patients' Cohort
Study Start Date : November 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1-ANNUAL
1. Zoledronic acid + Lifestyle modifications (experimental)
 Drug: Zoledronic acid
Zoledronic Acid 5mg/year
Behavioral: Lifestyle modifications
Lifestyle modifications
2-CONTROL
2. Lifestyle modifications (control)
 Behavioral: Lifestyle modifications
Lifestyle modifications
Experimental: 3-BIENNIAL
3. Zoledronic acid + Lifestyle modifications (experimental)
 Behavioral: Lifestyle modifications
Lifestyle modifications
Drug: Zoledronic acid
Zoledronic acid (5mg/2years)


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. Adverse events [ Time Frame: From baseline to week 96 ]
  2. Lab tests [ Time Frame: Evolution from baseline to week 96 ]
  3. Related clinical events (bone fractures) [ Time Frame: From baseline to week 96 ]
  4. Osteoblastic/Osteoclastic activity, bone formation/reabsorption. [ Time Frame: Evolution from baseline to week 48 ]
  5. Osteoblastic/Osteoclastic activity, bone formation/reabsorption. [ Time Frame: Evolution from baseline to week 96 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795483


Locations
Spain
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Investigators
Principal Investigator: Negredo Eugenia, MD,PhD LLuita contra la SIDA Foundation
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dra. EUGENIA NEGREDO PUIGMAL, Eugenia Negredo, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier: NCT00795483     History of Changes
Other Study ID Numbers: VIH-ZOL
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: August 9, 2012
Last Verified: August 2012

Keywords provided by Dra. EUGENIA NEGREDO PUIGMAL, Germans Trias i Pujol Hospital:
Osteoporosis
HIV infection
Bisphosphonates
Zoledronic acid

Additional relevant MeSH terms:
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Bone Density Conservation Agents
 HIV Infections
Osteoporosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Immunologic Deficiency Syndromes
Zoledronic acid
Diphosphonates
Physiological Effects of Drugs