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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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00662077
Enrollment
0
Registered
2008-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

osteoporosis, bifosfonates, ibandronate

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.

Interventions

DRUGIbandronate

Ibandronate endovenous 3 mg every 3 months

Lifestyle modifications: counseling every 3 months

Sponsors

Germans Trias i Pujol Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral densityBL, W24, W48, W72, W96

Secondary

MeasureTime frame
Adverse eventsBL, W12, W24, W36, W48, W60, W72, W80, W96
Lab testsBL, W12, W24, W36, W48, W60, W72, W80, W96
Related clinical events (bone fractures)BL, W12, W24, W36, W48, W60, W72, W80, W96
Osteoblastic/Osteoclastic activity, bone formation/reabsorption.BL, W12, W24, W36, W48, W60, W72, W80, W96

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026