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

Tracking Information

First Received Date ^ICMJE

July 11, 2005

Last Updated Date

December 21, 2011

Start Date ^ICMJE

October 2004

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00120757 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Osteoporosis
HIV Infections

Intervention ^ICMJE

Drug: Alendronate

Study Arm (s)

Not Provided

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

140

Completion Date

November 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00120757

Other Study ID Numbers ^ICMJE

2004-002002-30, ANRS120 Fosivir

Has Data Monitoring Committee

Yes

Responsible Party

French National Agency for Research on AIDS and Viral Hepatitis

Study Sponsor ^ICMJE

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Sylvie Rozenberg, MD	Hopital Pitie-Salpetriere Paris service de Rhumatologie
Study Chair:	Dominique Costagliola	Inserm U720

Information Provided By

French National Agency for Research on AIDS and Viral Hepatitis

Verification Date

December 2011

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

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