Alendronate for Prevention of AntiRetroviral Therapy-associated Bone Loss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-09-30

Brief Summary

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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.

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Detailed Description

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Multi-centre, prospective, randomised, double-blind, placebo-controlled trial over 50 weeks. The aims of this study include:

1. To determine if short-course treatment with alendronate versus placebo combined with calcium and vitamin D, initiated 2 weeks prior to start of ART and can prevent loss of BMD over 48 weeks of follow-up post ART initiation.
2. To explore the effect of alendronate on bone turnover in the setting of ART initiation.
3. To determine which factors, such as choice of ART, impacts the protective effect of alendronate in preventing BMD loss.
4. To determine the relationship between changes in bone turnover markers, vitamin D, parathyroid hormone and calcium levels.
5. To explore the pathogenesis of BMD loss with initiation of ART by investigating relationships between changes in immune function (T-cells and B-cells subsets), bone turnover and BMD.

Conditions

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Bone Demineralization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Alendronate

Alendronate 70 mg plus calcium/vitamin D (1250 mg/400iu) plus Truvada®

Group Type ACTIVE_COMPARATOR

Alendronate

Intervention Type DRUG

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

calcium carbonate and colecalciferol

Intervention Type DIETARY_SUPPLEMENT

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

Tenofovir disoproxil

Intervention Type DRUG

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

Placebo

Placebo to alendronate 70mg plus calcium/vitamin D (1250 mg/400iu) plus Truvada®

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

calcium carbonate and colecalciferol

Intervention Type DIETARY_SUPPLEMENT

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

Tenofovir disoproxil

Intervention Type DRUG

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

Interventions

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Alendronate

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

Intervention Type 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

Intervention Type DRUG

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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DRUG

Other Intervention Names

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Fosamax Romax Calcichew D3 forte Ideos Truvada

Eligibility Criteria

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Inclusion Criteria

* male\>30 years old or female\>35 years old
* HIV-1 antibody positive
* antiretroviral therapy naïve
* be presumed to have achieved peak bone mass
* be eligible for initiation of antiretroviral therapy in the opinion of the investigator
* be able to provide written, informed consent

Exclusion Criteria

* subjects unable to comply with the study protocol or unable to stand/sit upright for at least 30 minutes
* history of osteoporosis
* history of fragility fracture or previous femoral fracture
* chronic renal failure
* hypocalcemia or hypercalcemia at screening
* history of Paget's disease or known primary hyperparathyroidism
* previous treatment with or allergy (including hypersensitivity) to bisphosphonates
* recent history (past 12 months) of peptic or duodenal ulcers or oesophagitis, aspiration or any other abnormality of the oesophagus
* current therapy with prescribed calcium or vitamin D preparations (other than over-the-counter multivitamin preparations)
* current therapy with aspirin or other regularly prescribed non-steroidal anti-inflammatory drugs
* recent dental work (within the past 3 months) or poor oral hygiene (as judged in the opinion of the investigator)
* recent (within the past three months) significant steroid exposure
* for female subjects: pregnancy at screening, planning future pregnancies or unwilling to take measures to avoid pregnancy for the duration of the study
* where in the investigator's opinion, there is a necessity to initiate ART within the pre-ART study window period
* hepatitis B or hepatitis C co-infection
* any active illness (including AIDS illness) which in the opinion of the investigator precludes participation in the study
* subjects concurrently enrolled in another clinical trial of an investigational medical product

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No