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Calcium and Bone Mass in Young Females

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000402
First Posted: November 4, 1999
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:
Ohio State University
  Purpose

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.


Condition Intervention Phase
Osteoporosis Drug: Calcium Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Long Term Effects of Calcium on Bone Mass in Young Females

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Estimated Enrollment: 354
Study Start Date: August 1991
Estimated Study Completion Date: December 2001
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000402


Locations
United States, Ohio
OSU Bone and Mineral Metabolism Laboratory
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Velimir Matkovic, MD, PhD Ohio State University
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00000402     History of Changes
Other Study ID Numbers: R01AR040736 ( U.S. NIH Grant/Contract )
NIAMS-007
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: March 17, 2014
Last Verified: May 2013

Keywords provided by Ohio State University:
Osteoporosis
Dietary calcium
Puberty
Bone density
Bone mass
Primary prevention of osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs