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Home > "E" Clinical Trials Conditions > Encouraging Calcium Absorption and Bone Formation During Early Puberty  Encouraging Calcium Absorption and Bone Formation During Early Puberty
Encouraging Calcium Absorption and Bone Formation During Early Puberty
For Condition: Osteoporosis,Osteopenia
Status: No longer recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: Increasing bone mass during puberty can ultimately decrease the risk of developing osteoporosis, which causes bones to weaken and break more easily later in life. The purpose of this study is to compare calcium absorption and bone growth in boys and girls on diets including either a nondigestible oligosaccharide (NDO) or simple sugar.
Details: Rapid increases in bone mass occur during calcium absorption and bone calcium deposition during puberty, and these increases can enhance peak bone mass and ultimately decrease the lifetime risk of osteoporosis. However, dietary, hormonal, and genetic factors likely affect increased bone mass. This study will examine if adding NDO to a pubertal diet allows more absorption of calcium by the body, producing stronger bones. The study will also assess how the hormones produced by the body during puberty affect bone growth and whether genetic factors affect calcium absorption or bone growth. This study will last 2 years. At study entry, baseline pubertal hormone levels and bone mass will be assessed. Both a dual-energy X-ray absorptiometry (DEXA) scan and a calcium stable kinetic study measuring calcium absorption will be performed. Participants will then be randomly assigned to receive calcium fortified food with or without added NDO for 1 year. Calcium absorption will be measured again at 2 months. After the first year, calcium kinetic, hormonal, and DEXA studies will be performed and compared to baseline results. A final DEXA scan will be performed at the end of 2 years.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 9 Years/12 Years
Genders: Both
Protocol Entry Criteria: - Tanner Stage 2 or 3 - Girls must not have started menstruating - In the 10th to 90th percentile in body mass index (BMI) for their age
Total Enrollment: 100
Location and Contact Information:
Overall Study Official:
StevenAbrams, Principal Investigator, Baylor College of Medicine
Children's Nutrition Research Center at Baylor College of Medicine
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: NIAMS-067; R01 AR43740
Study Start Date: May 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022867
Other Osteoporosis Studies:
1. PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis
2. Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women with Postmenopausal Osteoporosis
3. Zometa - Femara Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women with Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy
4. Efficacy and safety study of intravenous ibandronate to treat postmenopausal osteoporosis as compared to daily oral ibandronate
5. Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer
Related Studies:
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Other Texas Clinical Trials
Other Houston Clinical Trials
Encouraging Calcium Absorption and Bone Formation During Early Puberty
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