Last updated on February 2018

Alendronate for Prevention of AntiRetroviral Therapy-associated Bone Loss

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Bone Demineralization | Pathologic
  • Age: Between 30 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • male>30 years old or female>35 years old
  • HIV-1 antibody positive
  • antiretroviral therapy nave
  • 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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