Osteoporosis Clinical Trial
Official title:
Long Term Effects of Calcium on Bone Mass in Young Females
We originally suggested that calcium in the diet is important in determining the amount of
bone (bone mass) that builds up in young adults. We are testing the effect of calcium on
bone mass in 354 Caucasian (white) girls. At the start of this 7-year study, the average age
of the girls was 11 years, and they had not yet reached puberty. The study will also provide
information about the effect of calcium on body composition (body fat) and blood pressure in
young women.
We have been giving calcium to one group of participants in this study and giving a placebo
(an inactive pill, or "sugar pill") to the other group. The results of this research will be
important in preventing osteoporosis, because building more bone as a young person should
reduce a woman's chances of developing osteoporosis later in life.
This study evaluates the effect of calcium on bone mass accretion over 7 years in a cohort
of 354 young females who were in pubertal Stage II at the start of the study. The average
age of study participants at entry was 11 years; at the end of the study participants were
18 years old.
The study looks at skeletal development under the influence of heredity, nutrition
(calcium), and physical exercise. We gave calcium to participants in one arm of this
clinical trial calcium. Participants in the other arm of the trial were given a placebo. The
main outcome variable is the bone mass measured at different skeletal regions.
The study will also provide data about the efficacy of calcium supplementation with regard
to hypertension prevention and obesity. The results of this research will be important in
preventing osteoporosis.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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