Effect of High-Calcium Milk and Weight-Bearing Exercise on Bone Mineral Status of Pre-Pubertal Girls
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      Osteoporosis has been described as a paediatric disease with a geriatric outcome. This is
      because bone mass is acquired during youth and is progressively lost later in life, without
      symptom or pain, until a fracture occurs. The proper management of osteoporosis includes
      improving bone mineral content in the first two decades of life so that reserves are built up
      before bone loss ensues.

      The investigators aim to determine the effect of a 10-month school-based provision of
      high-calcium milk and weight-bearing exercise program on the bone mineral status among
      prepubertal girls. The investigators' study is novel since it seeks to determine the effect
      of these interventions in girls, whose overall risks are much higher for osteoporosis later
      in life, and in a developing country population whose calcium intakes are more likely to be
      depleted.

      The investigators hypothesize that provision of either high-calcium milk or weight-bearing
      exercises will improve bone mineral density among prepubertal girls but that the bone accrual
      will be greater among those with both interventions. In addition, the investigators
      hypothesize that the changes will be more marked among those whose calcium intakes are lower.

      This study will use a two-by-two factorial design of 1) high-calcium milk (1000 mg/day) vs.
      placebo (115 mg/day) and 2) weight-bearing exercises (a total of 90 to 150 minutes per week
      divided into 3 to 5 schooldays) vs. no-exercise (passive activities) in a randomized
      controlled trial, for a total of 4 intervention groups: calcium+exercise, placebo+exercise,
      calcium+no exercise, placebo+no exercise.

      The study will be conducted among 80 prepubertal girls (on Tanner stage 1), aged 7-9 years
      and enrolled in one primary school in one of the metropolitan cities in the Philippines with
      an institution or a hospital with a Lunar Prodigy Central dual-energy x-ray absorptiometry
      (DEXA) machine.

      Osteoporosis has no treatment. The problem will continue to become burdensome in the future
      since population aging per se will increase the risk and incidence of fractures.
      Understanding the relationship between calcium and exercise is important since the greatest
      benefit is in the paediatric age range. The study results could provide information on a
      workable intervention that promotes the multiple health benefits of both exercise and
      high-calcium milk to young children.
    


Intervention name(s): milk and exercise
Intervention type(s): Other
Intervention description(s): milk fortified with 1000mg calcium or low-calcium milk
weight-bearing exercise or passive exercise
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: osteoporosis; calcium; weight-bearing exercise; bone mass; prepubertal girls