HIV InfectionsPhase 4NCT00795483
Efficacy And Security Of Annual And Biennial Zoledronic Acid For Osteoporosis Treatment In An HIV-Infected Patients' Cohort
A Phase 4 study testing Zoledronic acid and Lifestyle modifications in people with HIV Infections, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Zoledronic acid and Lifestyle modifications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2009to Nov 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Security of Annual and Biennial Zoledronic Acid for Osteoporosis Treatment in an HIV-infected Patients' Cohort
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Zoledronic acid, Lifestyle modifications
- Keywords
- Osteoporosis, HIV infection, Bisphosphonates, Zoledronic acid
- Medical subject headings
- HIV Infections, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
Zoledronic Acid 5mg/year
Lifestyle modificationsBehavioural
Lifestyle modifications
Zoledronic acidDrug
Zoledronic acid (5mg/2years)
| Study group | Role | What they receive |
|---|---|---|
| 1-ANNUAL | Experimental | 1. Zoledronic acid + Lifestyle modifications (experimental) Receives: Drug: Zoledronic acid; Behavioral: Lifestyle modifications |
| 2-CONTROL | Other | 2. Lifestyle modifications (control) Receives: Behavioral: Lifestyle modifications |
| 3-BIENNIAL | Experimental | 3. Zoledronic acid + Lifestyle modifications (experimental) Receives: Behavioral: Lifestyle modifications; Drug: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density
Measured: 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
Measured: Evolution from baseline to week 96
Secondary outcomes (5)
Adverse events
Measured: From baseline to week 96
Lab tests
Measured: Evolution from baseline to week 96
Related clinical events (bone fractures)
Measured: From baseline to week 96
Osteoblastic/Osteoclastic activity, bone formation/reabsorption.
Measured: Evolution from baseline to week 48
Osteoblastic/Osteoclastic activity, bone formation/reabsorption.
Measured: Evolution from baseline to week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startNov 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dra. EUGENIA NEGREDO PUIGMAL, Germans Trias i Pujol Hospital
- Investigators
- Negredo Eugenia, MD,PhD, Principal investigator, LLuita contra la SIDA Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795483
- Sponsor's protocol ID
- VIH-ZOL
- Status last verified
- Aug 2012
- First submitted
- 20 Nov 2008
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Security of Annual and Biennial Zoledronic Acid for Osteoporosis Treatment in an HIV-infected Patients' Cohort
- ClinicalTrials.gov ID
- NCT00795483
- Acronym / sponsor ID
- VIH-ZOL
- Conditions
- HIV Infections
- Keywords
- Osteoporosis, HIV infection, Bisphosphonates, Zoledronic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 21 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1-ANNUAL | Experimental | Drug: Zoledronic acid, Behavioral: Lifestyle modifications1. Zoledronic acid + Lifestyle modifications (experimental) |
| 2-CONTROL | Other | Behavioral: Lifestyle modifications2. Lifestyle modifications (control) |
| 3-BIENNIAL | Experimental | Behavioral: Lifestyle modifications, Drug: Zoledronic acid3. Zoledronic acid + Lifestyle modifications (experimental) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic acidZoledronic Acid 5mg/year | Drug | 1-ANNUAL |
| Lifestyle modificationsLifestyle modifications | Behavioural | 1-ANNUAL, 2-CONTROL, 3-BIENNIAL |
| Zoledronic acidZoledronic acid (5mg/2years) | Drug | 3-BIENNIAL |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Negredo Eugenia, MD,PhD principal investigator
LLuita contra la SIDA Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zoledronic acid and Lifestyle modifications in people with HIV Infections, run by Germans Trias i Pujol Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.