Stear 2003.
Methods | STUDY DESIGN: randomised controlled trial
LOCATION AND SETTING: Community (college), UK
DURATION OF SUPPLEMENTATION: 15.5 months
DURATION OF FOLLOW‐UP: 15.5 months
QUALITY ASSESSMENT: High risk of bias
RANDOMISED: States random but no description
ALLOCATION CONCEALMENT: Yes
BLINDING OF SUBJECT: Yes
DESCRIPTION OF WITHDRAWALS/DROPOUTS: No TYPE OF ANALYSIS: Available Data and treatment received COMPLIANCE: Assessed CONFOUNDERS MEASURED: spontaneous calcium intake and physical activity |
|
Participants | N SCREENED: unknown N RANDOMISED: 144 N COMPLETED: 131 (15.5 months) M=0% F=100% ETHNICITY: not stated MEAN BASELINE AGE (yrs): 17.3 BASELINE AGE RANGE (yrs): 16‐18 INCLUSION CRITERIA: female sixth form college students EXCLUSION CRITERIA: any medical problem, history of eating disorders, medication known to interfere with bone metabolism BASELINE CALCIUM INTAKE (mg/day): 938 PUBERTAL STAGE: post pubertal | |
Interventions | 1. 1000 mg/day of calcium as calcium carbonate 2. Placebo CO‐INTERVENTIONS: exercise (45 min 3 times per week aerobics with moderate to high impact movements) and no exercise groups | |
Outcomes | BONE MEASURES: SITES
AREAL BONE MINERAL DENSITY: unpublished data femoral neck, lumbar spine, distal radius.
BONE MINERAL CONTENT: total body, spine, radius (total, ultradistal, distal third), hip (total, femoral neck, trochanter, intertrochanter), lumbar spine
BONE AREA: total body, spine, radius (total, ultradistal, distal third), hip (total, femoral neck, trochanter, intertrochanter), lumbar spine
METHOD OF MEASUREMENT: DXA
FOLLOW‐UP ASSESSMENT POINTS(yrs): 0, 1.29
OTHER OUTCOMES MEASURED: weight, height,
BONE MEASURES INCLUDED IN ANALYSES:
AREAL BONE MINERAL DENSITY: unpublished data femoral neck, lumbar spine, distal radius.
BONE MINERAL CONTENT: total body, spine, radius (total, ultradistal, distal third), hip (total, femoral neck, trochanter, intertrochanter), lumbar spine
BONE AREA: total body, spine, radius (total, ultradistal, distal third), hip (total, femoral neck, trochanter, intertrochanter), lumbar spine SUB‐GROUPS IDENTIFIED: Exercise groups; high compliance groups for calcium and exercise |
|
Notes | Compliance to exercise was poor; only 27% of subjects attended more than 50% of the intervention target. Study also gives results as size‐adjusted BMC ie BMC adjusted for bone area, weight and height | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |