- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00662077
Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Barcelona
-
Badalona, Barcelona, Spain, 08916
- Germans Trias i Pujol Hospital - Lluita Sida Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Ibandronate + Lifestyle modifications
|
Ibandronate endovenous 3 mg every 3 months
Lifestyle modifications: counseling every 3 months
|
Other: 2
Lifestyle modifications
|
Lifestyle modifications: counseling every 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
BL, W24, W48, W72, W96
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: BL, W12, W24, W36, W48, W60, W72, W80, W96
|
BL, W12, W24, W36, W48, W60, W72, W80, W96
|
Lab tests
Time Frame: BL, W12, W24, W36, W48, W60, W72, W80, W96
|
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
|
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
|
BL, W12, W24, W36, W48, W60, W72, W80, W96
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eugenia Negredo, MD,PhD, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VIH-IBAN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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