Efficacy And Security Of Annual And Biennial Zoledronic Acid For Osteoporosis Treatment In An HIV-Infected Patients' Cohort

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dra. EUGENIA NEGREDO PUIGMAL, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00795483
First received: November 20, 2008
Last updated: August 8, 2012
Last verified: August 2012

November 20, 2008
August 8, 2012
November 2009
November 2011   (final data collection date for primary outcome measure)
  • Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density [ Time Frame: Evolution from baseline to week 48 ] [ Designated as safety issue: No ]
  • Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density [ Time Frame: Evolution from baseline to week 96 ] [ Designated as safety issue: No ]
Increase in lumbar (L2-4) and femoral (trochanter, femur neck, total femur and hip) t-score bone mineral density [ Time Frame: BL, W48, W96 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00795483 on ClinicalTrials.gov Archive Site
  • Adverse events [ Time Frame: From baseline to week 96 ] [ Designated as safety issue: Yes ]
  • Lab tests [ Time Frame: Evolution from baseline to week 96 ] [ Designated as safety issue: Yes ]
  • Related clinical events (bone fractures) [ Time Frame: From baseline to week 96 ] [ Designated as safety issue: Yes ]
  • Osteoblastic/Osteoclastic activity, bone formation/reabsorption. [ Time Frame: Evolution from baseline to week 48 ] [ Designated as safety issue: No ]
  • Osteoblastic/Osteoclastic activity, bone formation/reabsorption. [ Time Frame: Evolution from baseline to week 96 ] [ Designated as safety issue: No ]
  • 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, W48, W96 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy And Security Of Annual And Biennial Zoledronic Acid For Osteoporosis Treatment In An HIV-Infected Patients' Cohort
Efficacy and Security of Annual and Biennial Zoledronic Acid for Osteoporosis Treatment in an HIV-infected Patients' Cohort

The purpose of this project is to determine the incidence of osteoporosis in the investigators' population of HIV-infected patients and to assess the efficacy and security of zoledronic acid, whose efficacy in post-menopausal women with high fracture risk treatment and in Paget's disease treatment has already been demonstrated.

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-morbidity in the future, taking in care that in general population osteoporosis increases 4 times the pathologic fracture risk. That is 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 zoledronic acid. If the annual use of endovenous zoledronic acid 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 annual administration can improve compliance in patients who are receiving 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 makes of zoledronic acid a very promising alternative. Finally, there is no risk of digestive intolerance because of its parenteral administration and it has a better posology than oral bisphosphonates.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Zoledronic acid
    Zoledronic Acid 5mg/year
  • Behavioral: Lifestyle modifications
    Lifestyle modifications
  • Drug: Zoledronic acid
    Zoledronic acid (5mg/2years)
  • Experimental: 1-ANNUAL
    1. Zoledronic acid + Lifestyle modifications (experimental)
    Interventions:
    • Drug: Zoledronic acid
    • Behavioral: Lifestyle modifications
  • 2-CONTROL
    2. Lifestyle modifications (control)
    Intervention: Behavioral: Lifestyle modifications
  • Experimental: 3-BIENNIAL
    3. Zoledronic acid + Lifestyle modifications (experimental)
    Interventions:
    • Behavioral: Lifestyle modifications
    • Drug: Zoledronic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 18 years old or older.
  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. Creatinine over 2.3 mg/mL.
  4. Glomerular filter less than 50 mL/min (estimated through MDRD).
  5. Treatment for Osteoporosis in the last 4 months.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00795483
VIH-ZOL
No
Dra. EUGENIA NEGREDO PUIGMAL, Germans Trias i Pujol Hospital
Germans Trias i Pujol Hospital
Not Provided
Principal Investigator: Negredo Eugenia, MD,PhD LLuita contra la SIDA Foundation
Germans Trias i Pujol Hospital
August 2012

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