NCT00000426

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 1995

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1995

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2000

Completed
Last Updated

June 28, 2013

Status Verified

June 1, 2013

First QC Date

November 3, 1999

Last Update Submit

June 27, 2013

Conditions

Osteoporosis

Keywords

Calcium deficiencyDietary calciumDietary proteinOsteoporosisCalcium supplementBone densityBone massBone mass accumulation

Interventions

Calcium supplementDRUG

Eligibility Criteria

Age19 Years - 27 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women in good health
  • Dietary calcium-to-protein ratio (in mg:g, as assessed by 7-day food diary) does not exceed 13

You may not qualify if:

  • Smoking
  • Pregnancy
  • Lactation
  • Endocrine disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

Related Publications (1)

  • Heaney RP. Phosphorus nutrition and the treatment of osteoporosis. Mayo Clin Proc. 2004 Jan;79(1):91-7. doi: 10.4065/79.1.91.

    PMID: 14708952BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Robert P. Heaney, MD

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

January 1, 1995

Study Completion

June 1, 2000

Last Updated

June 28, 2013

Record last verified: 2013-06

Locations

US(1)