NCT00000402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
354

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 1991

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1991

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
Last Updated

May 22, 2013

Status Verified

May 1, 2013

First QC Date

November 3, 1999

Last Update Submit

May 21, 2013

Conditions

Osteoporosis

Keywords

OsteoporosisDietary calciumPubertyBone densityBone massPrimary prevention of osteoporosis

Interventions

CalciumDRUG

Eligibility Criteria

Age8 Years - 13 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Medications affecting calcium and bone metabolism
  • Chronic diseases
  • Metabolic bone disease
  • Abnormality in calcium metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OSU Bone and Mineral Metabolism Laboratory

Columbus, Ohio, 43210, United States

Location

Related Publications (10)

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

    PMID: 8951732BACKGROUND

  • 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.

    PMID: 7625351BACKGROUND

  • 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.

    PMID: 8113412BACKGROUND

  • 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.

    PMID: 8371847BACKGROUND

  • 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.

    PMID: 8461560BACKGROUND

  • 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.

    PMID: 1603119BACKGROUND

  • 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.

    PMID: 1570810BACKGROUND

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

    PMID: 1593603BACKGROUND

  • 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.

    PMID: 2239765BACKGROUND

  • 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.

    PMID: 14988471RESULT

MeSH Terms

Conditions

Osteoporosis

Interventions

Calcium

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Velimir Matkovic, MD, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

August 1, 1991

Study Completion

December 1, 2001

Last Updated

May 22, 2013

Record last verified: 2013-05

Locations

US(1)