# EFFECT OF ESTROGEN ON FEMORAL NECH BONE MASS

> **NIH NIH R01** · HENRY FORD HEALTH SYSTEM · 1992 · $200,161

## Abstract

Our program is already conducting a non-intervention study of changes in
bone mass and in biochemical markers of bone remodelling in women who
are ten years or more post menopause and have not been exposed to
postmenopausal hormone replacement therapy [HRT] (AR39657).  We are
about to begin a controlled clinical trial in the oldest 220 women from
this 375 women cohort.  That clinical trial (AG 10407) is part of the
STOP/IT program and is specifically restricted to persons aged 65 years
or older.  In this current proposal we will recruit the remaining 155
women into a parallel controlled clinical trial examining the
effectiveness of HRT in preventing bone loss from the femoral neck.
This will in effect increase our STOP/IT trial size to 375, with age
(less that 65, greater that 65) as a new stratum for randomization.
This larger trial will allow us to address important additional
questions which can not be answered in the smaller trial.  Of particular
importance is an assessment of whether chronologic age or years
postmenopause is a more specific determinant of the "age-related"
decline in bone mass and bone strength, and the responsivity to
therapies aimed at retarding or reversing this process.  To our
knowledge this question has not previously been addressed prospectively
in an aging female population.  The additional power of this larger
study will allow us to test the important subgroup hypothesis concerning
the potential additive effects of estrogen and progesterone on bone
mass.  The primary outcome variable of our trial is the effect of HRT
bone mass in femoral neck.  Secondary outcome variables are the effect
of therapy on a)spinal and total body bone mineral, b) selected
biochemical markers of bone remodelling and c) some aspects of quality
of life in this age group.  We will also prospectively monitor the
effect of HRT on serum total. HDL and LDL cholesterol, again looking
separately at the effects of estrogen and estrogen plus progesterone
compared to placebo.

## Key facts

- **NIH application ID:** 3122882
- **Project number:** 1R01AG010924-01
- **Recipient organization:** HENRY FORD HEALTH SYSTEM
- **SAM.gov UEI:** R9NXPE2GTCN9
- **Principal Investigator:** Michael KLEEREKOPER
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 1992
- **Award amount:** $200,161
- **Award type:** 1
- **Project period:** 1992-09-30 → 1997-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/3122882

## Citation

> US National Institutes of Health, RePORTER application 3122882, EFFECT OF ESTROGEN ON FEMORAL NECH BONE MASS (1R01AG010924-01). Retrieved via MORVS 2026-10-25 from https://api.morvs.ai/grant/nih/3122882. Licensed CC0.

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