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Completed

NCT Number: NCT00795483

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old or older.
  • Documented HIV-1 infection, with or without antiretroviral treatment.
  • 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).
  • Willing to follow the study protocol.
  • Informed Consent signature.

Exclusion criteria

  • In women, pregnancy or breastfeeding.
  • Other possible causes of secondary osteoporosis.
  • Creatinine over 2.3 mg/mL.
  • Glomerular filter less than 50 mL/min (estimated through MDRD).
  • Treatment for Osteoporosis in the last 4 months.

Treatment and study plan

Zoledronic acid

Drug

Zoledronic Acid 5mg/year

Lifestyle modifications

Behavioral

Lifestyle modifications

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Adverse events

    Time frame: From baseline to week 96

  2. Lab tests

    Time frame: Evolution from baseline to week 96

  3. Related clinical events (bone fractures)

    Time frame: From baseline to week 96

  4. Osteoblastic/Osteoclastic activity, bone formation/reabsorption.

    Time frame: Evolution from baseline to week 48

  5. Osteoblastic/Osteoclastic activity, bone formation/reabsorption.

    Time frame: Evolution from baseline to week 96

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 21, 2008
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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