DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Germans Trias i Pujol Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

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

Phase: Phase 4

Status: Suspended

Sponsored by: Germans Trias i Pujol Hospital

Official(s) and/or principal investigator(s):
Eugenia Negredo, MD,PhD, Principal Investigator, Affiliation: Fundacio Lluita Contra la SIDA

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Eligibility

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.

Locations and Contacts

Germans Trias i Pujol Hospital - Lluita Sida Foundation, Badalona, Barcelona 08916, Spain
Additional Information


Last updated: July 31, 2008

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017