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

Phase 4

Withdrawn

• Conditions: HIV Infections
• Interventions: Drug: Ibandronate; Behavioral: Lifestyle modifications

• Registration Number: NCT00662077
• Lead Sponsor: Germans Trias i Pujol Hospital

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.

Study Timeline

• Study First Submitted: 2008-04-17
• Study First Submitted QC: 2008-04-18
• Study First Posted: 2008-04-21
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lifestyle modifications	Ibandronate + Lifestyle modifications
2	Lifestyle modifications	Lifestyle modifications
1	Ibandronate	Ibandronate + Lifestyle modifications

Primary Outcome Measures

Name	Time	Method
Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density	BL, W24, W48, W72, W96

Secondary Outcome Measures

Name	Time	Method
Adverse events	BL, W12, W24, W36, W48, W60, W72, W80, W96
Lab tests	BL, 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

Trial Locations

Locations (1)

Germans Trias i Pujol Hospital - Lluita Sida Foundation; 🇪🇸 Badalona, Barcelona, Spain