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

Condition(s) targeted: Osteoporosis; HIV Infections

Intervention: Alendronate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: French National Agency for Research on AIDS and Viral Hepatitis

Official(s) and/or principal investigator(s):
Sylvie Rozenberg, MD, Principal Investigator, Affiliation: Hopital Pitie-Salpetriere Paris service de Rhumatologie
Dominique Costagliola, Study Chair, Affiliation: Inserm U720

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.

Official title: Efficacy of Alendronate Versus Placebo in the Treatment of HIV-1 Associated Osteoporosis, a Multicenter, Randomized, Controlled Trial. ANRS 120 Fosivir

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: 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:

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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

Service de Medecine Interne hopital Avicenne, Bobigny 93009 cedex, France

Hôpital Necker service des Maladies Infectieuses, Paris 75015, France

Service de Rhumatologie hopital Pitie-Salpetriere, Paris 75013, France

Starting date: October 2004
Last updated: December 21, 2011