Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Ibandronate
* Behavioral: Lifestyle modifications


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ibandronate + Lifestyle modifications | Drug: Ibandronate<br>* Ibandronate endovenous 3 mg every 3 months<br>Behavioral: Lifestyle modifications<br>* Lifestyle modifications: counseling every 3 months<br>|
| Other: 2<br>Lifestyle modifications | Behavioral: Lifestyle modifications<br>* Lifestyle modifications: counseling every 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density |  | BL, W24, W48, W72, W96 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | BL, W12, W24, W36, W48, W60, W72, W80, W96 | 
| Lab tests |  | BL, W12, W24, W36, W48, W60, W72, W80, W96 | 
| Related clinical events (bone fractures) |  | BL, W12, W24, W36, W48, W60, W72, W80, W96 | 
| Osteoblastic/Osteoclastic activity, bone formation/reabsorption. |  | BL, W12, W24, W36, W48, W60, W72, W80, W96 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, bifosfonates, ibandronate