NCT00662077

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Germans Trias i Pujol Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Ibandronate	Ibandronate endovenous 3 mg every 3 months
BEHAVIORAL	Lifestyle modifications	Lifestyle modifications: counseling every 3 months

Timeline

• First posted: 2008-04-21
• Last updated: 2019-03-13

Locations

1 site across 1 country: Spain