Clinical trial NCT00662077: Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort
Official title: Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: HIV Infections
Keywords: osteoporosis
bifosfonates
ibandronate
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2008-04-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density
timeFrame: BL, W24, W48, W72, W96
Secondary outcomes:
measure: Adverse events
timeFrame: BL, W12, W24, W36, W48, W60, W72, W80, W96
measure: Lab tests
timeFrame: BL, W12, W24, W36, W48, W60, W72, W80, W96
measure: Related clinical events (bone fractures)
timeFrame: BL, W12, W24, W36, W48, W60, W72, W80, W96
measure: Osteoblastic/Osteoclastic activity, bone formation/reabsorption.
timeFrame: BL, W12, W24, W36, W48, W60, W72, W80, W96
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Germans Trias i Pujol Hospital - Lluita Sida Foundation
state: Barcelona
Study officials:
affiliation: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
name: Eugenia Negredo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: