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Calcium and Bone Mass in Young Females
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Study NCT00000402   Information provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First Received: November 3, 1999   Last Updated: December 28, 2006   History of Changes

November 3, 1999
December 28, 2006
August 1991
 
 
 
Complete list of historical versions of study NCT00000402 on ClinicalTrials.gov Archive Site
 
 
 
Calcium and Bone Mass in Young Females
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.

Phase II
Interventional
Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Bio-equivalence Study
Osteoporosis
Drug: Calcium
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
354
December 2001
 

Inclusion Criteria:

  • Pubertal stage II
  • Calcium intake below a threshold level
  • Caucasian
  • Normal health

Exclusion Criteria:

  • Medications affecting calcium and bone metabolism
  • Chronic diseases
  • Metabolic bone disease
  • Abnormality in calcium metabolism
Female
8 Years to 13 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000402
 
R01 AR40736, NIAMS-007
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
 
Principal Investigator: Velimir Matkovic, MD, PhD Ohio State University College of Medicine
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
February 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP