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

Study Overview
=================
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.

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

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

Conditions
-----------------
Osteoporosis, HIV Infections

Intervention / Treatment
-----------------
* Drug: Alendronate


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alendronate|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis