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Home > "T" Clinical Trials Conditions > Treatment of Calcium Deficiency in Young Women  Treatment of Calcium Deficiency in Young Women
Treatment of Calcium Deficiency in Young Women
For Condition: Osteoporosis
Status: Completed
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: This study looks at the effects of calcium supplementation on bone density in women in their third decade of life. We placed women aged 19-27 who take in low amounts of calcium in their diets in one of two groups. We will give women in one group a placebo (inactive pill) and women in the other group 1500 milligrams of calcium per day (as calcium carbonate). We will monitor the results by looking at the change in bone mineral density measured at the hip, total body, forearm, and spine. Treatment will last 3 years.
Details: This is a randomized, controlled trial of calcium carbonate supplementation (1500 milligrams per day) in third-decade women with low calcium-to-protein intakes. We accept women aged 19-27 on the basis of good health and the 7-day food diary demonstrating a dietary calcium-to-protein ratio (in milligrams:grams) that does not exceed 13. The outcome variable is the change in BMD at hip, total body, forearm, and spine. Treatment lasts for 3 years. We expect that bone mass will increase in both groups but will increase to a greater extent in the calcium-supplemented group than in the nonsupplemented group.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 19 Years/27 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: - Women in good health - Dietary calcium-to-protein ratio (in mg:g, as assessed by 7-day food diary) does not exceed 13 Exclusion Criteria: - Smoking - Pregnancy - Lactation - Endocrine disease
Total Enrollment: 150
Location and Contact Information:
Overall Study Official:
RobertHeaney, Principal Investigator, Creighton University
Creighton University
Omaha, Nebraska, 68131
United States
Additional Information:
Study ID Numbers: NIAMS-005; R01 AR42155
Study Start Date: January 1995
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000426
Other Osteoporosis Studies:
1. A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
2. Preventing Osteoporosis in Adolescent Girls
3. PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis
4. The relationship between Vitamin D, fingernail thickness and bone density
5. Hormone Replacement Therapy to Treat Turner Syndrome
Related Studies:
Other Osteoporosis Clinical Trials
Other Nebraska Clinical Trials
Other Omaha Clinical Trials
Treatment of Calcium Deficiency in Young Women
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