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Osteoporosis Prevention in Preadolescent Girls

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Psychoeducational program
Sponsored by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Osteoporosis prevention, Behavioral/educational intervention, Preadolescent, Calcium, Exercise, Peak bone mass, Bone density

Eligibility Criteria

9 Years - 13 Years (Child)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 9- and 10-year-old premenarchal girls (girls who have not started their periods). Exclusion Criteria: Comorbid conditions or medications that are associated with decreased bone density such as the following: corticosteroids; anticonvulsants; thiazide diuretics; history of cancer; Type I diabetes; thyrotoxicosis; hyperparathyroidism; Cushing's syndrome; juvenile rheumatoid arthritis; connective tissue disease or hemolytic anemia; asthma which may limit ability to participate in the exercise intervention; known history of dietary disorder, including anorexia, bulimia or lactose intolerance; postmenarchal.

Sites / Locations

  • University Hospitals of Cleveland

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
December 28, 2006
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00000413
Brief Title
Osteoporosis Prevention in Preadolescent Girls
Official Title
Osteoporosis Prevention in Preadolescent Girls
Study Type
Interventional

2. Study Status

Record Verification Date
February 2003
Overall Recruitment Status
Completed
Study Start Date
July 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

5. Study Description

Brief Summary
This study will test an osteoporosis prevention program aimed at preadolescent girls between the ages of 10 and 12 who have not yet started their menstrual periods. Girls in this age group are adding large amounts of new bone to their skeletons. Adding more bone at this time of life can reduce a person's chances of developing osteoporosis (thinning bones) in later years. We will look at how this osteoporosis prevention program affects the amount of calcium in the girls' diets, the amount of weight-bearing exercise they do, and their bone mass measured using ultrasound testing of the heel.
Detailed Description
The study's objective is to demonstrate the efficacy of a behavioral/educational intervention in increasing levels of dietary calcium intake and weight-bearing exercise within an at-risk population in a stage of rapid accrual of bone mass-specifically, premenarchal girls between the ages of 10 and 12. We will use cluster randomization to randomize girls to either the intervention or a program of education only. We will randomize eighteen groups of girls into each arm of the study. The intervention consists of six interactive sessions using various media (i.e., overhead transparencies, graphics, and three-dimensional demonstrations) to present instructional material. Topics include an explanation of osteoporosis and its modifiable and nonmodifiable risk factors, prevention of osteoporosis via healthy food choices (i.e., high calcium, low fat foods), and prevention of osteoporosis via weight-bearing exercise. Each girl monitors her own progress toward the goal of 1350 to 1500 milligrams of calcium per day. A similar method allows simple self-monitoring of weight-bearing activity. The intervention program is reinforced via monthly self-monitoring for 18 months. The education-only program consists of six generic sessions on healthy eating, physical fitness, and healthy lifestyle choices. The primary outcomes of interest are higher calcium intake and higher levels of weight-bearing exercise. A secondary outcome of interest is increased broadband ultrasound attenuation of the os calcis, assessed using quantitative ultrasound. In summary, the group of girls targeted is ideal for this intervention because they are at a stage of rapid accrual of bone mass.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Osteoporosis prevention, Behavioral/educational intervention, Preadolescent, Calcium, Exercise, Peak bone mass, Bone density

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
340 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational program

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 9- and 10-year-old premenarchal girls (girls who have not started their periods). Exclusion Criteria: Comorbid conditions or medications that are associated with decreased bone density such as the following: corticosteroids; anticonvulsants; thiazide diuretics; history of cancer; Type I diabetes; thyrotoxicosis; hyperparathyroidism; Cushing's syndrome; juvenile rheumatoid arthritis; connective tissue disease or hemolytic anemia; asthma which may limit ability to participate in the exercise intervention; known history of dietary disorder, including anorexia, bulimia or lactose intolerance; postmenarchal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Kent Kwoh, MD
Organizational Affiliation
Case Western Reserve Univ. and Univ. Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12808010
Citation
Ievers-Landis CE, Burant C, Drotar D, Morgan L, Trapl ES, Kwoh CK. Social support, knowledge, and self-efficacy as correlates of osteoporosis preventive behaviors among preadolescent females. J Pediatr Psychol. 2003 Jul-Aug;28(5):335-45. doi: 10.1093/jpepsy/jsg023.
Results Reference
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Osteoporosis Prevention in Preadolescent Girls

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