Calcium and Bone Mass in Young Females

NCT ID: NCT00000402

Last Updated: 2013-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

354 participants

Study Classification

INTERVENTIONAL

Study Start Date

1991-08-31

Study Completion Date

2001-12-31

Brief Summary

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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

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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.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Calcium

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Principal Investigators

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Velimir Matkovic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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OSU Bone and Mineral Metabolism Laboratory

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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Matkovic V. Nutrition, genetics and skeletal development. J Am Coll Nutr. 1996 Dec;15(6):556-69. doi: 10.1080/07315724.1996.10718630.

Reference Type BACKGROUND
PMID: 8951732 (View on PubMed)

Matkovic V, Ilich JZ, Andon MB, Hsieh LC, Tzagournis MA, Lagger BJ, Goel PK. Urinary calcium, sodium, and bone mass of young females. Am J Clin Nutr. 1995 Aug;62(2):417-25. doi: 10.1093/ajcn/62.2.417.

Reference Type BACKGROUND
PMID: 7625351 (View on PubMed)

Matkovic V, Jelic T, Wardlaw GM, Ilich JZ, Goel PK, Wright JK, Andon MB, Smith KT, Heaney RP. Timing of peak bone mass in Caucasian females and its implication for the prevention of osteoporosis. Inference from a cross-sectional model. J Clin Invest. 1994 Feb;93(2):799-808. doi: 10.1172/JCI117034.

Reference Type BACKGROUND
PMID: 8113412 (View on PubMed)

Matkovic V, Ilich JZ. Calcium requirements for growth: are current recommendations adequate? Nutr Rev. 1993 Jun;51(6):171-80. doi: 10.1111/j.1753-4887.1993.tb03097.x.

Reference Type BACKGROUND
PMID: 8371847 (View on PubMed)

Matkovic V, Ilich J, Hsieh L. Influence of age, sex and diet on bone mass and fracture rate. Osteoporos Int. 1993;3 Suppl 1:20-2. doi: 10.1007/BF01621855. No abstract available.

Reference Type BACKGROUND
PMID: 8461560 (View on PubMed)

Matkovic V. Calcium intake and peak bone mass. N Engl J Med. 1992 Jul 9;327(2):119-20. doi: 10.1056/NEJM199207093270210. No abstract available.

Reference Type BACKGROUND
PMID: 1603119 (View on PubMed)

Matkovic V, Heaney RP. Calcium balance during human growth: evidence for threshold behavior. Am J Clin Nutr. 1992 May;55(5):992-6. doi: 10.1093/ajcn/55.5.992.

Reference Type BACKGROUND
PMID: 1570810 (View on PubMed)

Matkovic V. Osteoporosis as a pediatric disease: role of calcium and heredity. J Rheumatol Suppl. 1992 Apr;33:54-9.

Reference Type BACKGROUND
PMID: 1593603 (View on PubMed)

Matkovic V, Fontana D, Tominac C, Goel P, Chesnut CH 3rd. Factors that influence peak bone mass formation: a study of calcium balance and the inheritance of bone mass in adolescent females. Am J Clin Nutr. 1990 Nov;52(5):878-88. doi: 10.1093/ajcn/52.5.878.

Reference Type BACKGROUND
PMID: 2239765 (View on PubMed)

Matkovic V, Landoll JD, Badenhop-Stevens NE, Ha EY, Crncevic-Orlic Z, Li B, Goel P. Nutrition influences skeletal development from childhood to adulthood: a study of hip, spine, and forearm in adolescent females. J Nutr. 2004 Mar;134(3):701S-705S. doi: 10.1093/jn/134.3.701S.

Reference Type RESULT
PMID: 14988471 (View on PubMed)

Other Identifiers

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R01AR040736

Identifier Type: NIH

Identifier Source: secondary_id

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NIAMS-007

Identifier Type: -

Identifier Source: secondary_id

R01AR040736

Identifier Type: NIH

Identifier Source: org_study_id

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