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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Zoledronic acid
Behavioral: Lifestyle modifications
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Security of Annual and Biennial Zoledronic Acid for Osteoporosis Treatment in an HIV-infected Patients' Cohort

Resource links provided by NLM:


Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 33
Study Start Date: November 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1-ANNUAL
1. Zoledronic acid + Lifestyle modifications (experimental)
Drug: Zoledronic acid
Zoledronic Acid 5mg/year
Behavioral: Lifestyle modifications
Lifestyle modifications
2-CONTROL
2. Lifestyle modifications (control)
Behavioral: Lifestyle modifications
Lifestyle modifications
Experimental: 3-BIENNIAL
3. Zoledronic acid + Lifestyle modifications (experimental)
Behavioral: Lifestyle modifications
Lifestyle modifications
Drug: Zoledronic acid
Zoledronic acid (5mg/2years)

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-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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795483

Locations
Spain
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Investigators
Principal Investigator: Negredo Eugenia, MD,PhD LLuita contra la SIDA Foundation
  More Information

No publications provided

Responsible Party: Dra. EUGENIA NEGREDO PUIGMAL, Eugenia Negredo, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier: NCT00795483     History of Changes
Other Study ID Numbers: VIH-ZOL
Study First Received: November 20, 2008
Last Updated: August 8, 2012
Health Authority: Spain: Ministry of Health

Keywords provided by Germans Trias i Pujol Hospital:
Osteoporosis
HIV infection
Bisphosphonates
Zoledronic acid

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Musculoskeletal Diseases
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Diphosphonates
Zoledronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014