Researchers at the Osteoporosis and Metabolic Bone Disease Center and the Division of Gastroenterology at Loyola University Health System are studying a once-yearly, 15-minute infusion of an intravenous (IV) medication in patients with osteopenia (low bone mass) and inflammatory bowel diseases (IBD) that, if proven effective, may be considered the standard of treatment.
Loyola researchers hope that zoledronic acid, currently marketed under the brand name Zometa, will be effective and safe for patients with IBD.
“We want to give patients a more convenient treatment option to enhance compliance and to avoid common complications like fractures,” said Dr. Pauline Camacho, principal investigator of the study and director of the Osteoporosis and Metabolic Bone Disease Center at Loyola.
“Preliminary research indicates the 15-minute infusion could help patients with osteoporosis even when given just once a year.” Dr. Sohrab Mobarhan, chair of Loyola’s Division of Gastroenterology, serves as co-investigator of the study.
Patients with IBD are prone to bone loss because they have difficulty absorbing important nutrients like calcium and vitamin D. These patients are frequently treated with glucocorticoids, anti-inflammatory medications, which may cause osteopenia. Having osteopenia places a person at risk for developing osteoporosis, the thinning of the bones, which increases the risk of fractures.
To date, there is no cure or standard treatment for patients with IBD who suffer from bone loss. Oral osteoporosis medications such as alendronate and risedronate may exacerbate the problem because main side effects are gastric ulcers, abdominal pain and diarrhea, symptoms that IBD patients already have.
“With few existing options, the 15-minute IV medication could fill an important void in terms of treatment for these patients,” said Camacho, who also serves as assistant professor of medicine in the Department of Endocrinology and Metabolism at Loyola.
An estimated one million Americans have ulcerative colitis or Crohn’s disease, the two most common forms of IBD. These conditions, which can be painful and debilitating, cause chronic inflammation of the digestive tract. Ulcerative colitis and Crohn’s disease are very similar. In fact, they are often mistaken for one another. Both conditions inflame the lining of the digestive tract, and both can cause severe bouts of watery diarrhea and abdominal pain.
“We don’t know what exactly causes these diseases,” said Camacho. “However, the immune system and certain genetic and environmental factors may play a role.”
Loyola is currently recruiting 40 patients as part of the one-year study. Patients will be randomized to either the 15-minute infusion, along with vitamin D and calcium versus calcium and vitamin D only. Patients who receive the IV medication also would undergo tests to evaluate and measure bone formation, density and destruction at two weeks; one month; three months; six months and a year.
Zoledronic acid is approved by the Food and Drug Administration (FDA) to treat hypercalcemia (high levels of blood calcium) that may occur in patients with some types of cancer, or in cancers that have spread to the bones. Zoledronic acid works by acting on the cells that cause bones to be broken down. In addition, zoledronic acid is used to treat multiple myeloma – tumors formed by the bone marrow cells.