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Calcium and Bone Mass in Young Females

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Calcium
Sponsored by
Ohio State University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Osteoporosis, Dietary calcium, Puberty, Bone density, Bone mass, Primary prevention of osteoporosis

Eligibility Criteria

8 Years - 13 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • OSU Bone and Mineral Metabolism Laboratory

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
May 21, 2013
Sponsor
Ohio State University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00000402
Brief Title
Calcium and Bone Mass in Young Females
Official Title
Long Term Effects of Calcium on Bone Mass in Young Females
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 1991 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ohio State University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Osteoporosis, Dietary calcium, Puberty, Bone density, Bone mass, Primary prevention of osteoporosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
354 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Calcium

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Velimir Matkovic, MD, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
OSU Bone and Mineral Metabolism Laboratory
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8951732
Citation
Matkovic V. Nutrition, genetics and skeletal development. J Am Coll Nutr. 1996 Dec;15(6):556-69. doi: 10.1080/07315724.1996.10718630.
Results Reference
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PubMed Identifier
7625351
Citation
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.
Results Reference
background
PubMed Identifier
8113412
Citation
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.
Results Reference
background
PubMed Identifier
8371847
Citation
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.
Results Reference
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PubMed Identifier
8461560
Citation
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.
Results Reference
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PubMed Identifier
1603119
Citation
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.
Results Reference
background
PubMed Identifier
1570810
Citation
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.
Results Reference
background
PubMed Identifier
1593603
Citation
Matkovic V. Osteoporosis as a pediatric disease: role of calcium and heredity. J Rheumatol Suppl. 1992 Apr;33:54-9.
Results Reference
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PubMed Identifier
2239765
Citation
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.
Results Reference
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PubMed Identifier
14988471
Citation
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.
Results Reference
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Calcium and Bone Mass in Young Females

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