Clinical Trials

MainTitle

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

This study has been suspended
Sponsor
Germans Trias i Pujol Hospital


Information provided by (Responsible Party)
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier
NCT00662077

First received: April 17, 2008
Last updated: July 31, 2008
Last Verified: July 2008
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : Ibandronate
Behavioral : Lifestyle modifications
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort

Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures

  • Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density [ Time Frame: BL, W24, W48, W72, W96 ]
Secondary Outcome Measures:
  • Adverse events [ Time Frame: BL, W12, W24, W36, W48, W60, W72, W80, W96 ]
  • Lab tests [ Time Frame: BL, W12, W24, W36, W48, W60, W72, W80, W96 ]
  • Related clinical events (bone fractures) [ Time Frame: BL, W12, W24, W36, W48, W60, W72, W80, W96 ]
  • Osteoblastic/Osteoclastic activity, bone formation/reabsorption. [ Time Frame: BL, W12, W24, W36, W48, W60, W72, W80, W96 ]

Estimated Enrollment: 65

Arms Assigned Interventions
Experimental: 1
Ibandronate + Lifestyle modifications
Drug: Ibandronate

Ibandronate endovenous 3 mg every 3 months

Behavioral: Lifestyle modifications

Lifestyle modifications: counseling every 3 months

Other: 2
Lifestyle modifications
Behavioral: Lifestyle modifications

Lifestyle modifications: counseling every 3 months

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662077

Locations

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

Sponsors and Collaborators

Germans Trias i Pujol Hospital

Investigators

Principal Investigator: Eugenia Negredo, MD,PhD Fundacio Lluita Contra la SIDA
More Information

More Information


Responsible Party: LLuita Sida Foundation, LLuita Sida Foundation  
ClinicalTrials.gov Identifier: NCT00662077   History of Changes  
Other Study ID Numbers: VIH-IBAN  
Study First Received: April 17, 2008  
Last Updated: July 31, 2008  

Keywords provided by Germans Trias i Pujol Hospital:

osteoporosis
bifosfonates
ibandronate

Additional relevant MeSH terms:
HIV Infections
Osteoporosis
Ibandronic acid
Diphosphonates

ClinicalTrials.gov processed this data on December 18, 2017
This information is provided by ClinicalTrials.gov.