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Calcium and Bone Mass in Young Females

Long Term Effects of Calcium on Bone Mass in Young Females

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000402
Enrollment
354
Registered
1999-11-04
Start date
1991-08-31
Completion date
2001-12-31
Last updated
2013-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

Osteoporosis, Dietary calcium, Puberty, Bone density, Bone mass, Primary prevention of osteoporosis

Brief summary

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.

Detailed description

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.

Interventions

DRUGCalcium

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
8 Years to 13 Years
Healthy volunteers
Yes

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026