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

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:

MedlinePlus related topics: HIV/AIDS Osteoporosis

Drug Information available for: Alendronate sodium

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 (Adult, Senior)
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
Service de Rhumatologie hopital Pitie-Salpetriere
Paris, France, 75013
Hôpital Necker service des Maladies Infectieuses
Paris, France, 75015

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

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

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.


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:


HIV Infections Osteoporosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases	Immunologic Deficiency Syndromes Immune System Diseases Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Alendronate Bone Density Conservation Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016