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Calcium Intake Fracture Outcome Study

Effects of Calcium Supplementation on Clinical Fracture and Bone Structure: a 5-Year, Double-Blind, Placebo-Controlled Trial in Elderly Women (Calcium Intake Fracture Outcome Study)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000750583
Acronym
CAIFOS
Enrollment
1474
Registered
2015-07-21
Start date
1998-02-02
Completion date
1998-12-21
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Increased dietary calcium intake has been proposed as a population-based public health intervention to prevent osteoporotic fractures. We have examined whether calcium supplementation decreases clinical fracture risk in elderly women and its mechanism of action. This was a five-year, double-blind, placebo-controlled study of 1460 women recruited from the population and older than 70 years (mean age, 75 years) who were randomized to receive calcium carbonate, 600 mg twice per day, or identical placebo. The primary end points included clinical incident osteoporotic fractures, vertebral deformity, and adverse events ascertained in 5 years. Bone structure was also measured using dual x-ray absorptiometry of the hip and whole body, quantitative ultrasonography of the heel, and peripheral quantitative computed tomography of the distal radius.

Interventions

Five-year, double-blind, placebo-controlled study of 1460 women recruited from the population and older than 70 years (mean age, 75 years) who were randomized to receive calcium carbonate, 600 mg twice per day, or identical placebo.

Sponsors

University of Western Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
70 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

The key inclusion criteria was age greater than 70 years and less than or equal to 85 years, and likelihood to survive a 5-year study.

Exclusion criteria

Receipt of a bone active agent. There were no other specific exclusions so that the results could be generalized to the entire ambulant population.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 24, 2026