Alendronate for Prevention of AntiRetroviral Therapy-associated Bone Loss

• Register: ClinicalTrials.gov
• Last refreshed on: 30 May 2022
• Main ID: NCT02322099
• Date of registration: 17/12/2014
• Prospective Registration: Yes
• Primary sponsor: University College Dublin
• Public title: Alendronate for Prevention of AntiRetroviral Therapy-associated Bone Loss APART
• Scientific title: A Multi-centre, Prospective, Randomised Trial of Short Course Alendronate Therapy or Placebo Combined With Vitamin D and Calcium to Prevent Loss of Bone Mineral Density in Antiretroviral-naïve, HIV-1 Infected Subjects Initiating Antiretroviral Therapy
• Date of first enrolment: May 2016
• Target sample size: 53
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02322099
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Ireland

Contacts

• Name: Patrick WG Mallon, MB BCh BAO,PhD,FRCPI
• Affiliation: University College Dublin

Key inclusion & exclusion criteria

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



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bone Demineralization

Intervention(s)

Drug: Alendronate

Dietary Supplement: calcium carbonate and colecalciferol

Drug: Tenofovir disoproxil

Drug: Placebo

Primary Outcome(s)

Rate of changes in bone mineral density [Time Frame: 50 weeks]

Secondary Outcome(s)

Impact of ART choice on alendronate protective effect [Time Frame: 50 weeks]

Rate of changes in bone turnover markers [Time Frame: 50 weeks]

Secondary ID(s)

APART_2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Royal College of Surgeons, Ireland

Rush University Medical Center

Beaumont Hospital

Health Research Board, Ireland

Mater Misericordiae University Hospital