30th ASBMR 2008
[M366] Alendronate Treatment for Juvenile Osteoporosis. A Double-Blind, Randomized, Placebo-controlled Cross-Over Clinical Trial
Lyndon Key, Prema Madyastha, William Ries, Bruce Hollis, Frederick Reed.. Medical University of South Carolina.
A phase IIb, double-blind, crossover study was designed to demonstrate the efficacy and safety of alendronate treatment in juvenile osteoporosis. Twenty two children (age 5-13 years) with two or more fractures, associated with minimal or no trauma, were enrolled with a Z-score of <-2.0 SD based upon dual energy x-ray analysis. They were randomized using a permuted block design. In the first year (12 months), eleven children (group 1) received alendronate (35mg if patients <40kg, and 70mg if >40kg) along with calcium supplementation (500mg or 1000mg daily, using the same weight cutoffs and vitamin D 800 IU ). Another 11 children (group 2) received placebo, calcium and vitamin D. In the second year (12 months), they crossed over and received placebo (group 1)and alendronate (group 2) with calcium and vitamin supplements. Bone mineral density (BMD) of lumbar spine (LS) and hip were measured every 6 months. Biochemical markers of bone turnover (bone formation, serum bone-specific alkaline phosphatase, BSAP) and resorption (N-telopeptide, NTx) were also determined. At the end of first year, the BMD of LS increased significantly (11.6-45.6%) in group 1, as compared to a minimum increase in group 2 (3.9-10%). In the second year (crossover), group 1 continued to increase (13.8-49.5%) and group 2 increased to 8.2-46.5%. Although the BMD increased in all the participants at the end of two years, the increase in %BMD (group 1) was less than that over previous measurements (18.5% (6 mo), 6.5% (12 mo), 3.7% (18 mo), 1.8% (24 mo). This pattern was observed in group 2. Bone marker analyses correlated with the BMD increase. There was no side effects and no reduction in the rate of height growth. Children with multiple fractures and low bone density should be treated with alendronate as soon as they are diagnosed. It is possible that alendronate may inhibit the osteoclast activity for a short period of time.
L.L. Key, None.
Food and Drug Administration (FDA), Merck &Co
Date: Monday, September 15, 2008
Session Info: Poster: Osteoporosis Treatment (Clinical): Bisphosphonates (11:30 AM-2:30 PM)
Presentation Time: 11:30 AM