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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120757
• Other study ID #: 2004-002002-30
• Secondary ID: ANRS120 Fosivir
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2005
• Last updated: December 21, 2011
• Start date: October 2004
• Est. completion date: November 2008

Study information

• Verified date: December 2011
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• HIV Infections
• Osteoporosis

Intervention

Drug:
• Alendronate

Locations

Country	Name	City	State
France	Service de Medecine Interne hopital Avicenne	Bobigny
France	Hôpital Necker service des Maladies Infectieuses	Paris
France	Service de Rhumatologie hopital Pitie-Salpetriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of variation of femoral T-score between M0 and M24
Secondary	Percentages of variation of lumbar and femoral T score between M0 and M12
Secondary	Evolution of bone metabolism markers
Secondary	Occurrence of fractures
Secondary	Tolerance of alendronate
Secondary	Measure of the prevalence of osteopenia and osteoporosis in HIV-infected men and women
Secondary	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