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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00120757
First received: July 11, 2005
Last updated: December 21, 2011
Last verified: December 2011

July 11, 2005
December 21, 2011
October 2004
November 2008   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT00120757 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy of Alendronate Versus Placebo in the Treatment of HIV-associated Osteoporosis (ANRS120)
Efficacy of Alendronate Versus Placebo in the Treatment of HIV-1 Associated Osteoporosis, a Multicenter, Randomized, Controlled Trial. ANRS 120 Fosivir

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.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Osteoporosis
  • HIV Infections
Drug: Alendronate
Not Provided
Rozenberg S, Lanoy E, Bentata M, Viard JP, Valantin MA, Missy P, Darasteanu I, Roux C, Kolta S, Costagliola D; ANRS 120 Fosivir Study Group. Effect of alendronate on HIV-associated osteoporosis: a randomized, double-blind, placebo-controlled, 96-week trial (ANRS 120). AIDS Res Hum Retroviruses. 2012 Sep;28(9):972-80. Epub 2012 Mar 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00120757
2004-002002-30, ANRS120 Fosivir
Yes
French National Agency for Research on AIDS and Viral Hepatitis
French National Agency for Research on AIDS and Viral Hepatitis
Not Provided
Principal Investigator: Sylvie Rozenberg, MD Hopital Pitie-Salpetriere Paris service de Rhumatologie
Study Chair: Dominique Costagliola Inserm U720
French National Agency for Research on AIDS and Viral Hepatitis
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP