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

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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

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
Spain | |
Germans Trias i Pujol Hospital | |
Badalona, Barcelona, Spain, 08916 |
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 |
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 |