# FLUORIDE AND CALCIUM TREATMENT FOR OSTEOPOROSIS

> **NIH NIH R01** · MAYO CLINIC ROCHESTER · 1989 · $166,977

## Abstract

This is an ongoing clinical trial whose primary objectives are to determine
if sodium fluoride (NaF) and calcium (Ca) therapy for postmenopausal
osteoporosis is safe and is efficacious in reducing the incidence of
vertebral fractures.  Secondary objectives are to assess the effect of
therapy on bone mineral density (BMD) of the spine and hip; to determine if
skeletal response of individual patients (pts) to treatment varies and, if
so, what factors relate to therapeutic outcome; to study the incidence and
causes of impaired bone mineralization during fluoride therapy; and to
assess the effect in the occurrence of non-vertebral skeletal fractures.
202 osteoporotic women, ages 50 to 75 years, were randomly assigned to
parallel treatment and control arms.  Pts in the treatment arm receive 75
mg daily of NaF in divided doses whereas the control pts take a matching
placebo.  Pts in both treatment and control arms receive 1.5 g daily of Ca
as CaCO3 in divided doses.  Treatment is continued for 4 years (yrs).
Safety is assessed by continued contact with the pts, by interview and
examination every 6 months, and by evaluation with standard laboratory
tests every yr.  The number and degree of new vertebral fractures in the
two arms are assessed by the new and precise method of quantitative
biplanar roentgenography.  Individual resposiveness to therapy will be
assessed by serial determinations of BMD of lumbar spine, midradius and
proximal femur by single and dual photon absorptiometry and by measurement
of biochemical bone markers including serum bone Glaprotein.  Selected
groups will have metabolic balance studies for F-bioavailability and iliac
crest biopsies for quantitative bone histology and for F-content.

We will need a continuation of 3-yrs to complete the pt studies; complete
the laboratory measurements; check and verify the 400,000 data elements
that will have been collected; and complete data analysis.  While this is
being accomplished we will extend the treatment arm pts; for an additional
2 yrs to provide data that are needed to answer certain crucial questions
on long-term skeletal effects of F-treatment.  During the continuation
period, we also will perform measurements (serum 1,25(OH)2D, osteonectin
and other new biochemical bone markers, urine cyclic AMP and 6-yr bone
biopsies) on urine and serum samples stored at -70 degrees C.  These
measurements are in addition to those proposed in the original application.

## Key facts

- **NIH application ID:** 3155685
- **Project number:** 5R01AR028576-09
- **Recipient organization:** MAYO CLINIC ROCHESTER
- **SAM.gov UEI:** Y2K4F9RPRRG7
- **Principal Investigator:** B. LAWRENCE RIGGS
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 1989
- **Award amount:** $166,977
- **Award type:** 5
- **Project period:** 1981-08-01 → 1989-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/3155685

## Citation

> US National Institutes of Health, RePORTER application 3155685, FLUORIDE AND CALCIUM TREATMENT FOR OSTEOPOROSIS (5R01AR028576-09). Retrieved via MORVS 2026-10-24 from https://api.morvs.ai/grant/nih/3155685. Licensed CC0.

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