The effect of prophylactic treatment with risedronate on stress fracture incidence among infantry recruits.

When subjected to strains or strain rates higher than usual, the bone remodels to repair microdamage and to strengthen itself. During the initial resorption phase of remodeling, the bone is transitorily weakened and microdamage can accumulate leading to stress fracture. To determine whether short-term suppression of bone turnover using bisphosphonates can prevent the initial loss of bone during the remodeling response to high bone strain and strain rates and potentially prevent stress fracture, we conducted a randomized, double-blind, placebo-controlled trial of 324 new infantry recruits known to be at high risk for stress fracture. Recruits were given a loading dose of 30 mg of risedronate or placebo daily for 10 doses during the first 2 weeks of basic training and then a once a week maintenance dose for the following 12 weeks. Recruits were monitored by biweekly orthopedic examinations during 15 weeks of basic training for stress fractures. Bone scans for suspected tibial and femoral stress fractures and radiographs for suspected metatarsal stress fractures were used to verify stress fracture occurrence. By the intention-to-treat analysis and per-protocol analysis, there was no statistically significant difference in the tibial, femoral, metatarsal, or total stress fracture incidence between the treatment group and the placebo. We conclude that prophylactic treatment with risedronate in a training population at high risk for stress fracture using a maintenance dosage for the treatment of osteoporosis does not lower stress fracture risk.

RCT Entities:   Population Interventions Outcomes