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Sponsored by: |
Germans Trias i Pujol Hospital |
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Information provided by: | Germans Trias i Pujol Hospital |
ClinicalTrials.gov Identifier: | NCT00795483 |
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 |
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HIV |
Drug: Zoledronic acid Behavioral: Lifestyle modifications |
Phase IV |
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 |
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 |
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1: Experimental
1. Zoledronic acid + Lifestyle modifications (experimental)
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Drug: Zoledronic acid
Zoledronic Acid 5mg/year
Behavioral: Lifestyle modifications
Lifestyle modifications
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2: No Intervention
2. Lifestyle modifications (control)
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Behavioral: Lifestyle modifications
Lifestyle modifications
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Negredo Eugenia, MD,PhD | 93 465 78 97 | enegredo@flsida.org |
Spain, Barcelona | |
Germans Trias i Pujol Hospital | Recruiting |
Badalona, Barcelona, Spain, 08916 | |
Principal Investigator: Negredo Eugenia, MD,PhD |
Principal Investigator: | Negredo Eugenia, MD,PhD | LLuita contra la SIDA Foundation |
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 |
osteoporosis HIV infection bifosfonates zoledronic acid |
Diphosphonates Zoledronic acid Musculoskeletal Diseases HIV Infections |
Acquired Immunodeficiency Syndrome Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |