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Efficacy of Alendronate Versus Placebo in the Treatment of HIV-associated Osteoporosis (ANRS120)

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ClinicalTrials.gov Identifier: NCT00120757
Recruitment Status : Completed
First Posted : July 19, 2005
Last Update Posted : December 22, 2011
Sponsor:
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoporosis HIV Infections Drug: Alendronate Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy of Alendronate Versus Placebo in the Treatment of HIV-1 Associated Osteoporosis, a Multicenter, Randomized, Controlled Trial. ANRS 120 Fosivir
Study Start Date : October 2004
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Percentage of variation of femoral T-score between M0 and M24
  2. Percentages of variation of lumbar and femoral T score between M0 and M12
  3. Evolution of bone metabolism markers
  4. Occurrence of fractures
  5. Tolerance of alendronate
  6. Measure of the prevalence of osteopenia and osteoporosis in HIV-infected men and women
  7. 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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120757


Locations
France
Service de Medecine Interne hopital Avicenne
Bobigny, France, 93009 cedex
Service de Rhumatologie hopital Pitie-Salpetriere
Paris, France, 75013
Hôpital Necker service des Maladies Infectieuses
Paris, France, 75015
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: Sylvie Rozenberg, MD Hopital Pitie-Salpetriere Paris service de Rhumatologie
Study Chair: Dominique Costagliola Inserm U720
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00120757     History of Changes
Other Study ID Numbers: 2004-002002-30
ANRS120 Fosivir
First Posted: July 19, 2005    Key Record Dates
Last Update Posted: December 22, 2011
Last Verified: December 2011

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Osteoporosis

Additional relevant MeSH terms:
HIV Infections
Osteoporosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs