• Categories:News
• Author:
• Origin:
• Time of issue:2021-02-05 15:19
• Views:

(Summary description)Long-term complications of cystic fibrosis include osteoporosis and fragility fractures, but there are few data on effective treatment strategies, especially in younger patients. We investigated the treatment of low bone mineral density in children, adolescents and young cystic fibrosis patients. A study by Italian scholars showed that alendronate improved bone density in patients with cystic fibrosis. This multicenter randomized controlled study was conducted in two phases. Patients aged 5-30 years with cystic fibrosis and low bone density were first enrolled from 10 cystic fibrosis treatment centers in Italy. The phase I trial was a 12-month open study looking at the effects of adequate calcium intake and osteodiol. The Phase II study was a 12-month double-blind randomized placebo-controlled parallel group study of the safety and efficacy of oral alendronate in patients with less than 5% increase in bone mineral density from the Phase I study. Patients were randomly assigned to the oral alendronate and placebo groups in a double-blind study. We used dual-energy X-rays to observe BMD at baseline and at 6 months of treatment, corrected for weight, and assessed lumbar spine BMD. We assessed bone turnover index and other laboratory parameters every 3-6 months. The primary study endpoint was the mean increase in lumbar spine BMD in the intention-to-treat population. The results showed that we screened 540 cases and included 171 of these patients (mean age 13.8 years, range 5-30 years). During the observation period, 43 patients (25%) ingested calcium and osteodiol to increase BMD by more than 5%. The remaining 128 patients were entered into a randomized group trial. Patients in the alendronate group increased BMD by 16.3% (N=65) compared to 3.1% in the placebo group (N=63, p=0.001). 19 of 57 young patients (33.3%) treated with alendronate achieved an age-normal BMD Z-score. During the observation period, moderate hypercalciuria occurred in 5 patients, all of whom improved after a short interruption of osteodiol therapy. During the randomized study period, hypothermia occurred in 1 patient taking alendronate but not in patients in the placebo group. There were also no significant differences between the treatment and placebo groups in terms of other adverse effects.