NCT01968850

Brief Summary

This is a two-site, three-arm, open-label, pilot randomized controlled trial of bone anti-resorptive therapy during ART initiation in HIV-infected adults. Thirty (30) treatment-naïve HIV-infected adults initiating eligible first-line ART regimens will be randomized in a 1:1:1 fashion to one of the following three arms:

  1. 1.no bone anti-resorptive therapy (standard of care)
  2. 2.concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D;
  3. 3.a 24 week delay in initiation of a 24 week course of alendronate/vitamin D

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_2 hiv

Timeline
Completed

Started Apr 2014

Typical duration for phase_2 hiv

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

October 9, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 24, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

April 23, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2018

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

3.9 years

First QC Date

October 9, 2013

Last Update Submit

April 17, 2018

Conditions

HIV

Keywords

osteoporosisHIVbone Mineral Densityalendronatevitamin D

Outcome Measures

Primary Outcomes (1)

  • Percentage changes in BMD at a) the lumbar spine and b) proximal femur

    The primary analysis will compare the percentage changes in BMD for the two alendronate/vitamin D arms pooled against the control arm.

    48 weeks

Secondary Outcomes (5)

  • Feasibility

    48 weeks

  • Acceptability

    48 weeks

  • Safety/Tolerability

    48 weeks

  • Adherence

    48 weeks

  • Bone Biomarkers

    48 weeks

Study Arms (3)

no bone anti-resorptive therapy

NO INTERVENTION

(standard of care)

24-week tx of alendronate/vitamin D

EXPERIMENTAL

Concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D

Drug: alendronate/vitamin D

Delayed 24-week tx of alendronate/vitamin D

EXPERIMENTAL

a 24 week delay in initiation of a 24 week course of alendronate/vitamin D

Drug: alendronate/vitamin D

Interventions

alendronate/vitamin DDRUG

once weekly 70mg oral dose of alendronate co-formulated with 5600IU vitamin D3 (cholecalciferol) for 24 weeks.

Also known as: Fosavance 70/56
24-week tx of alendronate/vitamin DDelayed 24-week tx of alendronate/vitamin D

Eligibility Criteria

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

You may qualify if:

  • Documented HIV-1 infection
  • Adult (aged \>18 years or as per local guidelines)
  • Premenopausal, if female
  • Antiretroviral-naïve
  • Starting first-line ART including tenofovir/emtricitabine with either efavirenz (co-formulated as Atripla®) or elvitegravir, cobicistat (co-formulated as Stribild®)
  • Low (\<10%) ten-year fracture risk as assessed by the FRAX score validated for Canadian populations

You may not qualify if:

  • Presence of established osteoporosis at baseline as determined by BMD measurement
  • Prior or current use of any bone anti-resorptive therapy (eg. bisphosphonate, estrogens with the exception of oral contraceptive pills, etc.)
  • Inability to communicate in English
  • Creatinine clearance \<35 mL/min (using Cockcroft-Gault formula)
  • Hypersensitivity to alendronate, other bisphosphonates, or any component of the formulation
  • Hypocalcemia
  • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia
  • Inability to stand or sit upright for at least 30 minutes
  • Pregnancy, active plans to become pregnant, or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

AlendronateVitamin D

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Darrell Tan, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2013

First Posted

October 24, 2013

Study Start

April 23, 2014

Primary Completion

March 19, 2018

Study Completion

March 19, 2018

Last Updated

April 19, 2018

Record last verified: 2018-04

Locations

CA(2)