HIV InfectionsPhase 4NCT00662077
Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort
A Phase 4 study testing Ibandronate and Lifestyle modifications in people with HIV Infections, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Ibandronate and Lifestyle modifications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Start not givento not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or elder.
- 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.
- Creatinin over 2.3mg/mL
- Glomerular filter less than 50 mL/min (estimated through MDRD)
- Alendronate treatment in the last 6 months.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Germans Trias i Pujol Hospital - Lluita Sida Foundation
Badalona, Barcelona, 08916
About this study
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.
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-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.
- Conditions
- HIV Infections
- Being tested
- Ibandronate, Lifestyle modifications
- Keywords
- osteoporosis, bifosfonates, ibandronate
- 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.
IbandronateDrug
Ibandronate endovenous 3 mg every 3 months
Lifestyle modificationsBehavioural
Lifestyle modifications: counseling every 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ibandronate + Lifestyle modifications Receives: Drug: Ibandronate; Behavioral: Lifestyle modifications |
| 2 | Other | Lifestyle modifications Receives: Behavioral: Lifestyle modifications |
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: BL, W24, W48, W72, W96
Secondary outcomes (4)
Adverse events
Measured: BL, W12, W24, W36, W48, W60, W72, W80, W96
Lab tests
Measured: BL, W12, W24, W36, W48, W60, W72, W80, W96
Related clinical events (bone fractures)
Measured: BL, W12, W24, W36, W48, W60, W72, W80, W96
Osteoblastic/Osteoclastic activity, bone formation/reabsorption.
Measured: BL, W12, W24, W36, W48, W60, W72, W80, W96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
Why it stopped: Financial difficulties
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
- 0 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
- Eugenia Negredo, MD,PhD, Principal investigator, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662077
- Sponsor's protocol ID
- VIH-IBAN
- Status last verified
- Mar 2019
- First submitted
- 17 Apr 2008
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort
- ClinicalTrials.gov ID
- NCT00662077
- Acronym / sponsor ID
- VIH-IBAN
- Conditions
- HIV Infections
- Keywords
- osteoporosis, bifosfonates, ibandronate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Financial difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- First posted
- 21 Apr 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.
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.
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-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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ibandronate, Behavioral: Lifestyle modificationsIbandronate + Lifestyle modifications |
| 2 | Other | Behavioral: Lifestyle modificationsLifestyle modifications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old or elder.
- 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.
- Creatinin over 2.3mg/mL
- Glomerular filter less than 50 mL/min (estimated through MDRD)
- Alendronate treatment in the last 6 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 |
|---|---|---|
| IbandronateIbandronate endovenous 3 mg every 3 months | Drug | 1 |
| Lifestyle modificationsLifestyle modifications: counseling every 3 months | Behavioural | 1, 2 |
Primary outcome
Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density
Time frame: BL, W24, W48, W72, W96
4 secondary outcomes
Adverse events
Time frame: BL, W12, W24, W36, W48, W60, W72, W80, W96
Lab tests
Time frame: BL, W12, W24, W36, W48, W60, W72, W80, W96
Related clinical events (bone fractures)
Time frame: BL, W12, W24, W36, W48, W60, W72, W80, W96
Osteoblastic/Osteoclastic activity, bone formation/reabsorption.
Time frame: BL, W12, W24, W36, W48, W60, W72, W80, W96
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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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.
Eugenia Negredo, MD,PhD principal investigator
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
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 Ibandronate 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: withdrawn, as of the sponsor's last update on 13 Mar 2019. 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 was withdrawn before enrolling participants, so there are no results.
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: BL, W24, W48, W72, W96). 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 13 Mar 2019.