HIV Infections, Osteoporosis
Conditions
Keywords
Osteoporosis
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
Interventions
DRUGAlendronate
Sponsors
French National Agency for Research on AIDS and Viral Hepatitis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORSylvie Rozenberg, MD
Hopital Pitie-Salpetriere Paris service de Rhumatologie
STUDY_CHAIRDominique Costagliola
Inserm U720
Outcome results
None listed