Efficacy And Security Of Annual And Biennial Zoledronic Acid For Osteoporosis Treatment In An HIV-Infected Patients' Cohort
Germans Trias i Pujol Hospital
Information provided by (Responsible Party)
Dra. EUGENIA NEGREDO PUIGMAL, Germans Trias i Pujol Hospital
First received: November 20, 2008
Last updated: August 8, 2012
Last Verified: August 2012
History of Changes
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.
Drug : Zoledronic acid
Behavioral : Lifestyle modifications
Drug : Zoledronic acid
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|
Further study details as provided by Dra. EUGENIA NEGREDO PUIGMAL, 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: Evolution from baseline to week 48 ]
- 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 ]
- Adverse events [ Time Frame: From baseline to week 96 ]
- Lab tests [ Time Frame: Evolution from baseline to week 96 ]
- Related clinical events (bone fractures) [ Time Frame: From baseline to week 96 ]
- Osteoblastic/Osteoclastic activity, bone formation/reabsorption. [ Time Frame: Evolution from baseline to week 48 ]
- Osteoblastic/Osteoclastic activity, bone formation/reabsorption. [ Time Frame: Evolution from baseline to week 96 ]
|Study Start Date:||November 2009|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
1. Zoledronic acid + Lifestyle modifications (experimental)
Zoledronic Acid 5mg/year
Behavioral: Lifestyle modifications
2. Lifestyle modifications (control)
3. Zoledronic acid + Lifestyle modifications (experimental)
Drug: Zoledronic acid
Zoledronic acid (5mg/2years)
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.
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00795483
Locations Show More
|Germans Trias i Pujol Hospital|
|Badalona, Barcelona, Spain, 08916|
Sponsors and CollaboratorsGermans Trias i Pujol Hospital
|Principal Investigator:||Negredo Eugenia, MD,PhD||LLuita contra la SIDA Foundation|
|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|
|Study First Received:||November 20, 2008|
|Last Updated:||August 8, 2012|
Keywords provided by Dra. EUGENIA NEGREDO PUIGMAL, Germans Trias i Pujol Hospital:Osteoporosis
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.