NCT00120757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2004

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

December 22, 2011

Status Verified

December 1, 2011

Enrollment Period

4.1 years

First QC Date

July 11, 2005

Last Update Submit

December 21, 2011

Conditions

OsteoporosisHIV Infections

Keywords

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

AlendronateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Service de Medecine Interne hopital Avicenne

Bobigny, 93009 cedex, France

Location

Service de Rhumatologie hopital Pitie-Salpetriere

Paris, 75013, France

Location

Hôpital Necker service des Maladies Infectieuses

Paris, 75015, France

Location

Related Publications (1)

  • 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. doi: 10.1089/AID.2011.0224. Epub 2012 Mar 23.

    PMID: 22353022DERIVED

MeSH Terms

Conditions

OsteoporosisHIV Infections

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Sylvie Rozenberg, MD

    Hopital Pitie-Salpetriere Paris service de Rhumatologie

    PRINCIPAL INVESTIGATOR

  • Dominique Costagliola

    Inserm U720

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2005

First Posted

July 19, 2005

Study Start

October 1, 2004

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 22, 2011

Record last verified: 2011-12

Locations

FR(3)