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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoporosis
HIV Infections
 Drug: Alendronate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy of Alendronate Versus Placebo in the Treatment of HIV-1 Associated Osteoporosis, a Multicenter, Randomized, Controlled Trial. ANRS 120 Fosivir

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • 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:
  • 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
Estimated Enrollment: 140
Study Start Date: October 2004
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120757

Locations
France
Service de Medecine Interne hopital Avicenne
Bobigny, France, 93009 cedex
Hôpital Necker service des Maladies Infectieuses
Paris, France, 75015
Service de Rhumatologie hopital Pitie-Salpetriere
Paris, France, 75013
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: Sylvie Rozenberg, MD Hopital Pitie-Salpetriere Paris service de Rhumatologie
Study Chair: Dominique Costagliola Inserm U720
  More Information

No publications provided by French National Agency for Research on AIDS and Viral Hepatitis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00120757     History of Changes
Other Study ID Numbers: 2004-002002-30, ANRS120 Fosivir
Study First Received: July 11, 2005
Last Updated: December 21, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
 Alendronate
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015