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

Condition(s) targeted: HIV Infections

Intervention: Ibandronate (Drug); Lifestyle modifications (Behavioral)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Germans Trias i Pujol Hospital

Official(s) and/or principal investigator(s):
Eugenia Negredo, MD,PhD, Principal Investigator, Affiliation: FUNDACIÓ LLUITA CONTRA LA SIDA

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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density

Secondary outcome:

Adverse events

Lab tests

Related clinical events (bone fractures)

Osteoblastic/Osteoclastic activity, bone formation/reabsorption.

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. 18 years old or elder.

2. Documented HIV-1 infection, with or without antiretroviral treatment.

3. 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)

4. Willing to follow the study protocol.

5. Informed Consent signature.

Exclusion Criteria:

1. In women, pregnancy or breastfeeding.

2. Other possible causes of secondary osteoporosis.

3. Creatinin over 2. 3mg/mL

4. Glomerular filter less than 50 mL/min (estimated through MDRD)

5. Alendronate treatment in the last 6 months.

Germans Trias i Pujol Hospital - Lluita Sida Foundation, Badalona, Barcelona 08916, Spain; Not yet recruiting
Eugenia Negredo, MD,PhD, Phone: 93 465 78 97, Email: enegredo@flsida.org
Eugenia Negredo, MD,PhD, Principal Investigator

Starting date: May 2008
Ending date: May 2011
Last updated: April 18, 2008