- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00120757
Efficacy of Alendronate Versus Placebo in the Treatment of HIV-associated Osteoporosis (ANRS120)
December 21, 2011 updated by: French National Agency for Research on AIDS and Viral Hepatitis
Efficacy of Alendronate Versus Placebo in the Treatment of HIV-1 Associated Osteoporosis, a Multicenter, Randomized, Controlled Trial. ANRS 120 Fosivir
Osteopenia and osteoporosis are being described more frequently in people with HIV infection.
This study will test the efficacy of alendronate in comparison with a placebo after 2 years, in people with primary osteoporosis.
People will receive the recommended adequate intake of calcium and vitamin D.
Study Overview
Detailed Description
The purposes of this trial are:
- To study the efficacy of alendronate in HIV-associated osteoporosis
- To measure the prevalence of osteoporosis in HIV patients and to detect risk factors in a large cohort of HIV patients from the screening phase
Study Type
Interventional
Enrollment
140
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bobigny, France, 93009 cedex
- Service de Medecine Interne hopital Avicenne
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Paris, France, 75015
- Hôpital Necker service des Maladies Infectieuses
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Paris, France, 75013
- Service de Rhumatologie hopital Pitie-Salpetriere
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Non-pregnant
- Non menopausal women
- Total femur BMD below -2.5 SD (T score) or lumbar spine BMD below -2.5 SD (T score) or BMD below -1 associated with a vertebral osteoporotic fracture (diminution of vertebral height over 20%)
- HIV infection known for at least 5 years
- CD4 cell count over 50/mm3
- Karnofsky score over or equal to 70
- Written informed consent.
Exclusion Criteria:
- Osteoporosis resulting from a cause other than HIV: vitamin D deficiency (in that case, after receiving high-dose calcium and vitamin D for 1 month, patients will be randomized without a new screening), renal failure, heart failure (NHYA class III or IV), treatment with glucocorticoid at a dose over or equal to 0.5mg/kg/d for 15 days or more at time of inclusion or during the previous 6 months; thyroid or other endocrine disease if untreated for more than 6 months; hypercalciuria
- Testosterone below normal if treatment is hormonal
- BMI below or equal to 18
- Severe lung failure
- Chronic alcohol intoxication
- Ongoing opportunistic infection
- Gastric ulcer of disease interfering with oesophageal motility in the previous 3 months
- History of treatment for osteoporosis
- History of malignancy in the previous 5 years (except skin cancer and Kaposi)
- Cytotoxic chemotherapy or cytokine therapy
- Liver cirrhosis
- Breast feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Percentage of variation of lumbar BMD on DEXA scan at month 24 versus month 0 for patients included with lumbar osteoporosis (femoral for those included with only femoral osteoporosis)
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Secondary Outcome Measures
Outcome Measure |
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Percentage of variation of femoral T-score between M0 and M24
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Percentages of variation of lumbar and femoral T score between M0 and M12
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Evolution of bone metabolism markers
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Occurrence of fractures
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Tolerance of alendronate
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Measure of the prevalence of osteopenia and osteoporosis in HIV-infected men and women
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Description of the evolution of osteoporosis in HIV-infected men and women receiving calcium and vitamin D to define risk factors for osteoporosis in HIV-infected persons
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sylvie Rozenberg, MD, Hopital Pitie-Salpetriere Paris service de Rhumatologie
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
July 11, 2005
First Submitted That Met QC Criteria
July 18, 2005
First Posted (Estimate)
July 19, 2005
Study Record Updates
Last Update Posted (Estimate)
December 22, 2011
Last Update Submitted That Met QC Criteria
December 21, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004-002002-30
- ANRS120 Fosivir
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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