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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: | NCT00662077 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Ibandronate Behavioral: Lifestyle modifications |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort |
Estimated Enrollment: | 65 |
Arms | Assigned Interventions |
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1: Experimental
Ibandronate + Lifestyle modifications
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Drug: Ibandronate
Ibandronate endovenous 3 mg every 3 months
Behavioral: Lifestyle modifications
Lifestyle modifications: counseling every 3 months
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2
Lifestyle modifications
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Behavioral: Lifestyle modifications
Lifestyle modifications: counseling every 3 months
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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-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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain, Barcelona | |
Germans Trias i Pujol Hospital - Lluita Sida Foundation | |
Badalona, Barcelona, Spain, 08916 |
Principal Investigator: | Eugenia Negredo, MD,PhD | FUNDACIÓ LLUITA CONTRA LA SIDA |
Responsible Party: | LLuita Sida Foundation ( LLuita Sida Foundation ) |
Study ID Numbers: | VIH-IBAN |
Study First Received: | April 17, 2008 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00662077 History of Changes |
Health Authority: | Spain: Ministry of Health |
osteoporosis bifosfonates ibandronate |
Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Osteoporosis Bone Diseases, Metabolic Bone Density Conservation Agents Bone Diseases Immunologic Deficiency Syndromes |
Virus Diseases Musculoskeletal Diseases Ibandronic acid HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Physiological Effects of Drugs Acquired Immunodeficiency Syndrome Osteoporosis Bone Density Conservation Agents Bone Diseases, Metabolic Infection |
Bone Diseases Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Ibandronic acid Musculoskeletal Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |