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	Intervention	Phase
Osteoporosis HIV Infections	Drug: Alendronate	Phase III

Further Study Details: 

Primary Outcomes: 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 Outcomes: Percentage of variation of femoral T-score between M0 and M24; Percentages of variation of lumbar and femoral T score between M0 and M12; Evolution of bone metabolism markers; Occurrence of fractures; Tolerance of alendronate; Measure of the prevalence of osteopenia and osteoporosis in HIV-infected men and women; 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
Expected Total Enrollment:  140

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00120757

Sylvie Rozenberg, MD      00 33 1 42 17 7814    sylvie.rozenberg@psl.ap-hop-paris.fr
Michelle Bentata, MD      00 33 1 48 95 51 44    hiv.bentata@avc.ap-hop-paris.fr

France
      Service de Rhumatologie hopital Pitie-Salpetriere, Paris,  75013,  France; Recruiting
      Hôpital Necker service des Maladies Infectieuses, Paris,  75015,  France; Recruiting
      Service de Medecine Interne hopital Avicenne, Bobigny,  93009 cedex,  France; Recruiting

Study chairs or principal investigators

Sylvie Rozenberg, MD,  Principal Investigator,  Hopital Pitie-Salpetriere Paris service de Rhumatologie   
Dominique Costagliola,  Study Chair,  Inserm U720   

Study ID Numbers:  2004-002002-30; ANRS120 Fosivir
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 18, 2005
ClinicalTrials.gov Identifier:  NCT00120757
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-07-26