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

NCT ID: NCT00662077

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Ibandronate + Lifestyle modifications

Group Type: EXPERIMENTAL

Ibandronate

Intervention Type: DRUG

Ibandronate endovenous 3 mg every 3 months

Lifestyle modifications

Intervention Type: BEHAVIORAL

Lifestyle modifications: counseling every 3 months

2

Lifestyle modifications

Group Type: OTHER

Lifestyle modifications

Intervention Type: BEHAVIORAL

Lifestyle modifications: counseling every 3 months

Interventions

Ibandronate

Ibandronate endovenous 3 mg every 3 months

Intervention Type: DRUG

Lifestyle modifications

Lifestyle modifications: counseling every 3 months

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Germans Trias i Pujol Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dra. EUGENIA NEGREDO PUIGMAL

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eugenia Negredo, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Locations

Germans Trias i Pujol Hospital - Lluita Sida Foundation

Badalona, Barcelona, Spain

Countries

Spain

Other Identifiers

VIH-IBAN

Identifier Type: -

Identifier Source: org_study_id