N/A N=739 Randomized Basic Science

Jump-In: Building Better Bones

Adolescent Development

Bottom Line

View on ClinicalTrials.gov: NCT00729378 ↗

Enrolled (actual)

739

Serious AEs

0.0%

Results posted

Dec 2017

Primary outcome: Primary: Baseline Total Volumetric Bone Density at the Femur 4% Site — 277.25; 270.79 milligrams per cubic centimeter (mg/ccm)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Skeletal loading (Other)
Age: Pediatric · 9+ yrs
Sex: Female
Sponsor: University of Arizona
Primary completion: Apr 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Baseline Total Volumetric Bone Density at the Femur 4% Site	277.25; 270.79	—
PRIMARY Baseline Volumetric Bone Density of Trabecular Bone at the Femur 4% Site	239.32; 232.34	—
PRIMARY Baseline Volumetric Bone Density of Cortical Bone at the Femur 4% Site	273.80; 267.89	—
PRIMARY Baseline Trabecular Bone Area at the Femur 4% Site	1039.55; 1053.15	—
PRIMARY Baseline Cortical Bone Area at the Femur 4% Site	1335.56; 1348.65	—
PRIMARY Baseline Periosteal Circumference at the Femur 4% Site	124.91; 125.63	—
PRIMARY Baseline Bone Strength Index at the Femur 4% Site	96.77; 93.52	—
PRIMARY Baseline Total Volumetric Bone Density at the Femur 20% Site	489.70; 478.72	—
PRIMARY Baseline Volumetric Bone Density of Trabecular Bone at the Femur 20% Site	163.81; 153.11	—
PRIMARY Baseline Volumetric Bone Density of Cortical Bone at the Femur 20% Site	1046.01; 1045.20	—
PRIMARY Baseline Periosteal Circumference at the Femur 20% Site	77.43; 77.78	—
PRIMARY Baseline Cortical Thickness at the Femur 20% Site	2.52; 2.50	—
PRIMARY Baseline Stress-Strain Index at the Femur 20% Site	1340.19; 1344.66	—
PRIMARY Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site	224.03; 219.74	—
PRIMARY Baseline Total Volumetric Bone Density at the Tibia 4% Site	297.27; 291.62	—
PRIMARY Baseline Volumetric Bone Density of Cortical Bone at the Tibia 4% Site	297.40; 291.93	—
PRIMARY Baseline Trabecular Bone Area at the Tibia 4% Site	467.73; 475.80	—
PRIMARY Baseline Cortical Bone Area at the Tibia 4% Site	617.19; 625.57	—
PRIMARY Baseline Periosteal Circumference at the Tibia 4% Site	85.86; 86.43	—
PRIMARY Baseline Bone Strength Index at the Tibia 4% Site	52.45; 51.03	—
PRIMARY Baseline Total Volumetric Bone Density at the Tibia 50% Site	745.69; 736.33	—
PRIMARY Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site	137.39; 131.63	—
PRIMARY Baseline Volumetric Bone Density of Cortical Bone at the Tibia 50% Site	1070.32; 1070.95	—
PRIMARY Baseline Periosteal Circumference at the Tibia 50% Site	61.98; 62.33	—
PRIMARY Baseline Cortical Thickness at the Tibia 50% Site	4.05; 4.00	—
PRIMARY Baseline Stress-Strain Index at the Tibia 50% Site	1004.97; 1023.74	—
PRIMARY Baseline Total Volumetric Bone Density at the Tibia 66% Site	566.04; 552.71	—
PRIMARY Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site	159.04; 152.34	—
PRIMARY Baseline Volumetric Bone Density of Cortical Bone at the Tibia 66% Site	1029.42; 1026.07	—
PRIMARY Baseline Periosteal Circumference at the Tibia 66% Site	71.55; 72.34	—
PRIMARY Baseline Cortical Thickness at the Tibia 66% Site	3.06; 3.02	—
PRIMARY Baseline Stress-Strain Index at the Tibia 66% Site	1167.94; 1187.31	—
PRIMARY 12-month Change in Total Volumetric Bone Density the Femur 4% Site	3.10; 2.83	—
PRIMARY 12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site	3.37; 5.89	—
PRIMARY 12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site	2.14; 1.68	—
PRIMARY 12-month Change in Trabecular Bone Area at the Femur 4% Site	104.16; 144.97	—
PRIMARY 12-month Change in Cortical Bone Area at the Femur 4% Site	140.00; 185.50	—
PRIMARY 12-month Change in Periosteal Circumference at the Femur 4% Site	6.17; 8.09	—
PRIMARY 12-month Change in Bone Strength Index at the Femur 4% Site	12.84; 15.03	—
PRIMARY 12-month Change in Total Volumetric Bone Density at the Femur 20% Site	2.40; -2.46	—
PRIMARY 12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site	7.12; 5.77	—
PRIMARY 12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site	6.87; 4.39	—
PRIMARY 12-month Change in Thickness of Cortical Bone at the Femur 20% Site	.11; .11	—
PRIMARY 12-month Change in Periosteal Circumference at the Femur 20% Site	4.89; 5.65	—
PRIMARY 12-month Change in Stress-Strain Index at the Femur 20% Site	261.94; 297.43	—
PRIMARY 12-month Change in Total Volumetric Bone Density at the Tibia 4% Site	9.87; 10.34	—
PRIMARY 12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site	2.84; 2.36	—
PRIMARY 12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site	9.69; 10.10	—
PRIMARY 12-month Change in Trabecular Bone Area at the Tibia 4% Site	29.87; 24.65	—
PRIMARY 12-month Change in Cortical Bone Area at the Tibia 4% Site	44.85; 39.53	—
PRIMARY 12-month Change in Periosteal Circumference at the Tibia 4% Site	3.17; 2.77	—
PRIMARY 12-month Change in Bone Strength Index at the Tibia 4% Site	7.84; 7.46	—
PRIMARY 12-month Change in Total Volumetric Bone Density at the Tibia 50% Site	17.98; 17.76	—
PRIMARY 12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site	-2.74; -3.16	—
PRIMARY 12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site	14.34; 11.16	—
PRIMARY 12-month Change in Periosteal Circumference at the Tibia 50% Site	2.98; 3.11	—
PRIMARY 12-month Change in Cortical Thickness at the Tibia 50% Site	.29; .31	—
PRIMARY 12-month Change in Stress-Strain Index at the Tibia 50% Site	171.82; 185.36	—
PRIMARY 12-month Change in Total Volumetric Bone Density at the Tibia 66% Site	7.00; 9.58	—
PRIMARY 12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site	3.40; 2.08	—
PRIMARY 12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site	11.63; 12.69	—
PRIMARY 12-month Change in Periosteal Circumference at the Tibia 66% Site	3.69; 3.79	—
PRIMARY 12-month Change in Cortical Thickness at the Tibia 66% Site	.17; .18	—
PRIMARY 12-month Change in Stress-Strain Index at the Tibia 66% Site	214.93; 228.46	—
PRIMARY 24-month in Change in Total Volumetric Bone Density the Femur 4% Site	13.70; 13.47	—
PRIMARY 24-month in Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site	8.03; 8.23	—
PRIMARY 24-month in Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site	10.67; 10.78	—
PRIMARY 24-month Change in Trabecular Bone Area at the Femur 4% Site	160.89; 178.04	—
PRIMARY 24-month Change in Cortical Bone Area at the Femur 4% Site	237.12; 255.67	—
PRIMARY 24-month Change in Periosteal Circumference at the Femur 4% Site	10.08; 10.72	—
PRIMARY 24-month Change in Bone Strength Index at the Femur 4% Site	28.08; 27.81	—
PRIMARY 24-month Change in Total Volumetric Bone Density at the Femur 20% Site	14.88; 15.36	—
PRIMARY 24-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site	11.83; 9.04	—
PRIMARY 24-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site	21.56; 22.26	—
PRIMARY 24-month Change in Thickness of Cortical Bone at the Femur 20% Site	.27; .31	—
PRIMARY 24-month Change in Periosteal Circumference at the Femur 20% Site	8.25; 9.29	—
PRIMARY 24-month Change in Stress-Strain Index at the Femur 20% Site	504.12; 582.69	—
PRIMARY 24-month Change in Total Volumetric Bone Density at the Tibia 4% Site	28.22; 26.76	—
PRIMARY 24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site	7.37; 7.23	—
PRIMARY 24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site	27.29; 25.94	—
PRIMARY 24-month Change in Trabecular Bone Area at the Tibia 4% Site	34.81; 35.83	—
PRIMARY 24-month Change in Cortical Bone Area at the Tibia 4% Site	65.50; 66.42	—
PRIMARY 24-month Change in Periosteal Circumference at the Tibia 4% Site	4.64; 4.65	—
PRIMARY 24-month Change in Bone Strength Index at the Tibia 4% Site	17.28; 16.86	—
PRIMARY 24-month Change in Total Volumetric Bone Density at the Tibia 50% Site	37.26; 39.83	—
PRIMARY 24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site	-3.51; -4.00	—
PRIMARY 24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site	33.70; 31.06	—
PRIMARY 24-month Change in Periosteal Circumference at the Tibia 50% Site	5.26; 5.27	—
PRIMARY 24-month Change in Cortical Thickness at the Tibia 50% Site	.51; .53	—
PRIMARY 24-month Change in Stress-Strain Index at the Tibia 50% Site	322.78; 336.49	—
PRIMARY 24-month Change in Total Volumetric Bone Density at the Tibia 66% Site	17.83; 19.26	—
PRIMARY 24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site	4.48; 1.69	—
PRIMARY 24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site	28.96; 31.06	—
PRIMARY 24-month Change in Periosteal Circumference at the Tibia 66% Site	6.75; 6.82	—
PRIMARY 24-month Change in Cortical Thickness at the Tibia 66% Site	.32; .32	—
PRIMARY 24-month Change in Stress-Strain Index at the Tibia 66% Site	421.49; 435.13	—

Summary

The Jump-In study will prospectively assess the effects of impact exercise on skeletal development in young girls, including bone mass, bone mineral density, and bone geometry. We hypothesize that girls who regularly participate in impact loading exercise will accrue greater skeletal mass, increase bone density and undergo structural adaptations that in combination will improve bone strength compared to girls who do not participate in impact exercise.

Eligibility Criteria

Inclusion Criteria

female; entering 4th or 6th grade at enrollment; and willing and able to undergo all of the testing requirements; no physical conditions that limit participation in physical activity/exercise; able to read and write English.

Exclusion Criteria

Girls with severe learning disabilities (identified by schools), who are unable to complete questionnaires or otherwise comply with assessment protocols will be excluded. Any subjects (or potential subjects) suffering from medical conditions and/or disabilities that would limit their participation in exercise will be excluded from the study, following the American Academy of Pediatrics (AAP) guidelines. Further, any volunteers who are taking medications that would limit exercise and/or alter bone mineral accrual will also be excluded from the study. Girls with a positive pregnancy screening test at the time of the lab visit before DXA scanning will be excluded.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00729378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.