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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00662077
• Other study ID #: VIH-IBAN
• Status: Withdrawn
• Phase: Phase 4

Study information

• Verified date: March 2019
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Osteoporosis

Intervention

Drug:
• Ibandronate
Ibandronate endovenous 3 mg every 3 months

Behavioral:
• Lifestyle modifications
Lifestyle modifications: counseling every 3 months

Locations

Country	Name	City	State
Spain	Germans Trias i Pujol Hospital - Lluita Sida Foundation	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events		BL, W12, W24, W36, W48, W60, W72, W80, W96
Secondary	Lab tests		BL, W12, W24, W36, W48, W60, W72, W80, W96
Secondary	Related clinical events (bone fractures)		BL, W12, W24, W36, W48, W60, W72, W80, W96
Secondary	Osteoblastic/Osteoclastic activity, bone formation/reabsorption.		BL, W12, W24, W36, W48, W60, W72, W80, W96