MUSC Children's Hospital - Research - Fosamax in Juvenile Osteoporosis

We're all about children!

Juvenile Osteoporosis Clinical Trial (HR:#11143)

Title of Clinical Trial: A Randomized, Double-blind, Placebo-Controlled, Prospective, Cross-Over Phase II Clinical Trial to Determine the Safety and Efficacy of Alendronate Sodium (Fosamax®) in Juvenile Osteoporosis.

Location: This clinical trial will take place in MUSC Children's Hospital's department of pediatric endocrinology in Rutledge Tower located at 135 Rutledge Avenue, in downtown Charleston, SC.

This is a clinical research study sponsored by the Food and Drug Administration and co-sponsored by the Merck Pharmaceuticals. This study is designed to determine the safety and efficacy of Fosamax® (alendronate sodium) in children with low bone density and osteoporosis.

Our researcher have determined that there is 67 percent chance that patients with more than one fracture without significant trauma (auto accident or fall from over 10 feet) have low bone density. In our earlier clinical trial, also sponsored by the FDA, we studied 10 children with low bone density and osteoporosis. These children were treated with Fosamax® therapy for 12 months. The current study is designed to determine the safety and efficacy of Fosamax® along with control medication (inactive pill). Twenty children will participate in this study for a two-year period. The FDA considers Fosamax® as an investigational drug. The details of the study are described below.

Study details and eligibility criteria: Voluntary participants in the age group of 5 to 15 years are needed for a new two-year clinical trial assessing the treatment in juvenile osteoporosis, sponsored by the Food and Drug Administration (FDA) and Merck Pharmaceuticals. Male and female children weighing 20 kg (44 pounds) and more, from all ethnic groups with a history of one or more fractures are eligible for the study. Merck Pharmaceuticals, the co-sponsor of the study will provide the study medication Fosamax® and an inactive placebo (dummy pill). In the first of the two years, 10 patients will receive the active treatment with Fosamax®, while the other 10 will be treated with the placebo (inactive pill). In the second year, those children receiving the inactive pill (placebo) during the first year will be switched (crossed) over to the active medication (Fosamax®). Those having received the active medication (Fosamax®) will be switched to the placebo (dummy pills). Once found eligible and enrolled in the study, patients will be randomized (put into one of the two groups by chance) into one of the two treatment groups for year 1.

The current clinical trial is a double-blinded, placebo-controlled study to determine the safety and efficacy of Fosamax® in juvenile osteoporosis. This means that both the participants and the investigators will not know which participant is treated with Fosamax® and which one is treated with placebo until the study is completed. The total duration of the study is two years.

During the initial screening and once every six months, blood work, and urinalysis will be done to obtain pre-treatment values and also to determine the effect of the Fosamax® treatment. A bone scan using the DEXA (bone density) machine will be done to determine the bone mineral density, the measure of osteoporosis. A physical examination, height, weight and vital signs will be performed at each visit.

There is no cost for participation in the study. The study-related clinic visits, DEXA bone scan, blood work and the urinalysis are all done free-of-charge. Merck Pharmaceuticals is providing Fosamax® free-of-charge.

Dr. Lyndon Key, chairman of the department of pediatrics and a pediatric endrincologist is the prinicpal investigator of this study.

Interested participants/parents and the referring physicians should call:

Prema Madyastha, Ph.D.
Co-Principal Investigator
Pediatric Endocrinology
Tel: 843-792-1346

To learn more about juvenile osteoporsis, visit our health library.