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

This study has suspended participant recruitment.
(Financial difficulties)
Sponsor:
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00662077
First received: April 17, 2008
Last updated: July 31, 2008
Last verified: July 2008

April 17, 2008
July 31, 2008
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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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00662077 on ClinicalTrials.gov Archive Site
  • Adverse events [ Time Frame: BL, W12, W24, W36, W48, W60, W72, W80, W96 ] [ Designated as safety issue: Yes ]
  • Lab tests [ Time Frame: BL, W12, W24, W36, W48, W60, W72, W80, W96 ] [ Designated as safety issue: Yes ]
  • Related clinical events (bone fractures) [ Time Frame: BL, W12, W24, W36, W48, W60, W72, W80, W96 ] [ Designated as safety issue: Yes ]
  • Osteoblastic/Osteoclastic activity, bone formation/reabsorption. [ Time Frame: BL, W12, W24, W36, W48, W60, W72, W80, W96 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort
Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Ibandronate
    Ibandronate endovenous 3 mg every 3 months
  • Behavioral: Lifestyle modifications
    Lifestyle modifications: counseling every 3 months
  • Experimental: 1
    Ibandronate + Lifestyle modifications
    Interventions:
    • Drug: Ibandronate
    • Behavioral: Lifestyle modifications
  • 2
    Lifestyle modifications
    Intervention: Behavioral: Lifestyle modifications
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
65
Not Provided
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00662077
VIH-IBAN
No
LLuita Sida Foundation
Germans Trias i Pujol Hospital
Not Provided
Principal Investigator: Eugenia Negredo, MD,PhD Fundacio Lluita Contra la SIDA
Germans Trias i Pujol Hospital
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP