Omaha, Nebraska 68131

  • Osteoporosis

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

R01 AR42155


NCT ID:

NCT00000426


Secondary ID:

R01AR042155


Study Acronym:


Brief Title:

Treatment of Calcium Deficiency in Young Women


Official Title:

Treatment of Calcium Deficiency in Young Women


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

19 Years


Maximum Age:

27 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Creighton University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

150


Enrollment Type:


Overall Contact Information

Official Name:Robert P. Heaney, MD
Principal Investigator
Creighton University

Study Dates

Start Date:January 1995
Completion Date:June 2000
Verification Date:June 2013
Last Changed Date:June 27, 2013
First Received Date:November 3, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Calcium supplement

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Creighton University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Heaney RP. Phosphorus nutrition and the treatment of osteoporosis. Mayo Clin Proc. 2004 Jan;79(1):91-7. Review.
PMID:14708952

Data Source: ClinicalTrials.gov

Date Processed: July 23, 2021

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