Alendronate for Prevention of AntiRetroviral Therapy-associated Bone Loss

Summary

Antiretroviral therapy (ART) initiation is associated with a significant loss of bone mineral density (BMD), characterised by increases in bone turnover, which is largely limited to the first 48 weeks of therapy. Bisphosphonates, such as alendronate, decrease bone turnover and can limit loss of bone mineral density.

This study aims to determine if a short course of treatment with the oral bisphosphonate alendronate can limit loss of bone mineral density associated with initiation of ART in HIV-1 infected, antiretroviral naive, adult subjects.

Conditions

• Bone Demineralization

Interventions

DRUG

Alendronate

alendronate 70 mg tablets to be administered weekly for a total of 14 weeks, commencing 2 weeks prior to ART initiation

DRUG

Placebo

Sugar pill manufactured to mimic alendronate 70 mg tablet administered weekly for a total of 14 weeks, commencing 2 weeks prior to ART

DIETARY_SUPPLEMENT

calcium carbonate and colecalciferol

Calcium carbonate 1250 mg (equivalent to 500 mg of elemental calcium) and colecalciferol 400 iu (equivalent to 10 micrograms of vitamin D3) tablets administered twice daily for a total of 14 weeks, commencing 2 weeks prior to ART initiation

DRUG

Tenofovir disoproxil

Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label) commencing 2 weeks after alendronate initiation and continuing for 48 weeks

Sponsors & Collaborators

• Health Research Board, Ireland

  collaborator OTHER

• Royal College of Surgeons, Ireland

  collaborator OTHER

• Mater Misericordiae University Hospital

  collaborator OTHER

• Beaumont Hospital

  collaborator OTHER

• Rush University Medical Center

  collaborator OTHER

• University College Dublin

  lead OTHER

Principal Investigators

• Patrick WG Mallon, MB BCh BAO,PhD,FRCPI · University College Dublin

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2019-09-30

Completion

2019-09-30

Countries

• Ireland

Study Locations