Randomized, placebo-controlled trial of oral calcium supplementation for osteopenia in girls and women with Rett syndrome
Objective: The investigators conducted a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of oral calcium supplementation for the treatment of bone mineral deficits in individuals with Rett syndrome (RTT). Methods: The investigators measured total body bone mineral content (BMC) and bone mineral density (BMD) by dual-energy x-ray absorptiometry and biomarkers of bone turnover by clinical laboratory techniques before and one year after oral calcium or placebo supplementation in 32 pre- and post-pubertal girls and young women with RTT. The calcium supplement was calculated to provide a twofold increase in the recommended dietary allowance of calcium for age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Bone mineral content (BMC)
Bone mineral content (z-score) measured by dual-energy x-ray absorptiometry
Time frame: change from baseline to 1 year thereafter
Bone mineral density (BMD)
Bone mineral density (z-score) measured by dual-energy x-ray absorptiometry
Time frame: change from baseline to 1 year thereafter
Osteocalcin
Serum Osteocalcin (ng/ml)
Time frame: change from baseline to 1 year thereafter
Bone alkaline phosphatase
Serum Bone alkaline phosphatase (mcg/ml)
Time frame: change from baseline to 1 year thereafter
C-telopeptide
Serum C-telopeptide (pg/ml)
Time frame: change from baseline to 1 year thereafter
Calcium/creatinine ratio
Urinary calcium/creatinine ratio (mg/g)
Time frame: change from baseline to 1 year thereafter
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