# PTH (1-34) and pelvic fracture healing: A randomized controlled trial

> **NIH NIH U01** · HOSPITAL FOR SPECIAL SURGERY · 2021 · $356,297

## Abstract

Technical Abstract
The incidence rate of pelvic fractures increases dramatically with age, from 5.4 and 3.8 per 10,000 person-
years in women and men aged 65 to 69 years to 93.5 and 44.5 per 10,000 person-years in women and men
aged 90 years and older, respectively. Pelvic fractures are accompanied by severe pain, chronic immobility
and loss of function and independence in the elderly. Pelvic fractures consume substantial healthcare
resources, and based on administrative claims data, they are one of the most costly osteoporosis related
fractures. Un-healed fractures, occurring in one-third of pelvic fracture patients at 3 months, can cause
continued pain and impact mobility. With aging of the population, and expected concomitant increase in the
incidence of pelvic fractures, there is a pressing need to find effective treatments that will accelerate healing.
Fracture of the pubic ramus is most relevant and practical for randomized double-blinded placebo controlled
study as this fracture is accompanied by severe pain and immobility in elderly, is associated with delayed
fracture healing, and is almost always treated non-operatively. The current standard of care for pelvic fractures
includes pain management, patient mobilization, and the prevention of complications associated with comorbid
conditions. We hypothesize that development of a successful adjunctive therapy to accelerate fracture healing
would lead to improved care and reduce both direct and indirect costs from pelvic fractures. In the proposed
trial we will recruit women and men >65 years of age with acute osteoporosis-related pelvic fractures and
address 3 specific aims over 3 months of treatment in a placebo controlled double blind study to determine if
standard care and teriparatide 20 mcg/day versus placebo for pelvic fractures:
1. Results in earlier evidence of cortical bridging on routine radiographs followed by confirmatory Focus CT, a
novel method to reduce radiation exposure from CT scans (primary outcome).
2. Leads to a faster reduction in pain as assessed by both the Numeric Rating Scale and a reduction in the use
of narcotics (secondary outcome).
3. Leads more rapidly to improved functional outcome using a short physical performance battery to assess
lower extremity function (secondary outcome).
We will extend this study with 9 months of open label TPTD to determine if any potential differences between
the placebo and TPTD groups during the 3 months of treatment are evident and persist over time, even in
patients who use TPTD after the three month placebo controlled intervention.
If TPTD can improve fracture healing, this study will have an impact on the treatment of persons with pelvic
fracture who are not surgical candidates and often face severe pain, chronic immobility, and loss of function in
the elderly. A positive finding of accelerated healing of pelvic fractures would also encourage study of TPTD
for treatment of other osteoporotic fractures.

## Key facts

- **NIH application ID:** 10179318
- **Project number:** 5U01AR069869-06
- **Recipient organization:** HOSPITAL FOR SPECIAL SURGERY
- **Principal Investigator:** JERI WANZOR NIEVES
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $356,297
- **Award type:** 5
- **Project period:** 2019-05-23 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10179318

## Citation

> US National Institutes of Health, RePORTER application 10179318, PTH (1-34) and pelvic fracture healing: A randomized controlled trial (5U01AR069869-06). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10179318. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*