Non-Therapeutic Protocol

P1076: Impact of Oral Alendronate Therapy on Bone Mineral Density in HIV-Infected Children and Adolescents with Low Bone Mineral Density

Type of Protocol/Clinical Study

Associated Infectious Diseases Studies : Human Immunodeficiency Virus (HIV)

Description

HIV infected children, youth and adults have lower BMD (bone marrow density) than would be expected for healthy people of similar age, weight and race. As the majority of perinatally HIV infected US children are entering or in adolescence, the potential for HIV-related impaired BMD during the adolescent peak of bone mass acquisition is of particular concern.

This is is a pilot study to assess the effect of 48 weeks of alendronate therapy on BMD in HIV-infected youth with low BMD. It is clear that older adults with low bone density have a higher risk of spinal fracture or other broken bone. Many experts believe that children and youth with low bone density are also at risk of a spinal fracture or other broken bone over time. There are some things that can keep or make bones stronger, like getting enough vitamin D, calcium, and exercise and not smoking cigarettes. There are also drugs, like alendronate, that work by stopping bones from losing the minerals that make them strong.

Alendronate (brand name Fosamax^®) is a drug approved by the Food and Drug Administration (FDA) to treat and prevent low bone density and prevent broken bones in adults. This study is being done to see if alendronate can safely improve bone density more than vitamin D, calcium and exercise alone in children and youth with HIV infection who already have low bone density.

Objectives

• This study is being done to find out if alendronate, plus calcium and vitamin D, is safe and effective for treating low bone density in children and youth infected with HIV.
• To evaluate the effect of alendronate therapy on changes in HIV status (as measured by changes in viral load, CD4% and CDC disease category) and determine if the changes in these outcomes correlate with changes in BMD.
• To assess the effect of other known bone mineral determinants (age, gender, race/ethnicity, steroid use, Depo-Provera, tenofovir, pubertal stage, bone age, vitamin D status) and inflammatory cytokine levels on changes in BMD after alendronate treatment.

Eligibility

• ≥11 to < 25 years of age
• Documentation of HIV-1 infection defined as positive results from two samples collected at different time points.
• Availability for routine dental exam and care every 6 months
• Demonstrated ability and willingness to swallow study medications

Principal Investigator

Aditya Gaur, MD

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