# THEORETICAL AND THERAPEUTIC ASPECTS OF CALCIFICATION

> **NIH NIH R01** · UT SOUTHWESTERN MEDICAL CENTER · 1991 · $249,579

## Abstract

The overall objective of this proposal is to develop a safe and effective
restoration of lost bone in postmenopausal osteoporosis, entailing
intermittent treatment with slow release sodium fluoride (SR-NaF) and
continuous calcium citrate (CaCit) supplementation, which avoids toxicity
and problems of conventional fluoride therapy.  The primary hypothesis to
be tested is that intermittent application of SR-NAF with continuous Cacit
supplementation provides safety of usage, maintains serum fluoride within
the "therapeutic window" during prolonged therapy, augments spinal bone
mass persistently, and inhibits spinal fractures without exaggerating hip
fractures.  Validation of these predictions, suggested largely from a non-
randomized trial, will be sought from a placebo-controlled randomized
trial (SR-NAF 25 mg bid + CaCit 400 mg Ca bid vs. placebo + CaCit 400 mg
Ca bid). 200 women with postmenopausal osteoporosis (100 in each group)
will be followed for 4 years.  The response to treatment will be
quantitated by bone densitometry (whole body, ulnar head and shaft,
proximal femur, L2-L4 whole spine and body), skeletal x-rays (read on
electrostatic digitizing pad for fractures), and by in vivo reflection
ultrasound analysis of ulnar head.  The reflection ultrasound analysis is
a new technique developed at Dallas to assess quantitatively and non-
invasively the mechanical property of bone.  The choice of ulnar head is
justified by a strong correlation between bone density of L2-L4 and distal
ulna, a fall in reflection ultrasound velocity at ulnar head with aging,
and a lower velocity in osteoporotic individuals with spinal fractures
than in osteopenic individual without fractures.  The in Vivo ultrasound
analysis is critical to confirm the finding in from the examination of
iliac crest biopsy specimens that SR-NaF plus CaCit increases reflection
ultrasound velocity and the material strength of bone.

## Key facts

- **NIH application ID:** 3154867
- **Project number:** 2R01AR016061-20A1
- **Recipient organization:** UT SOUTHWESTERN MEDICAL CENTER
- **SAM.gov UEI:** YZJ6DKPM4W63
- **Principal Investigator:** CHARLES Y.C PAK
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 1991
- **Award amount:** $249,579
- **Award type:** 2
- **Project period:** 1976-05-01 → 1996-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/3154867

## Citation

> US National Institutes of Health, RePORTER application 3154867, THEORETICAL AND THERAPEUTIC ASPECTS OF CALCIFICATION (2R01AR016061-20A1). Retrieved via MORVS 2026-10-24 from https://api.morvs.ai/grant/nih/3154867. Licensed CC0.

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