Clinical trial NCT00594906: Use of Teriparatide to Accelerate Fracture Healing
Official title: Use of Teriparatide to Accelerate Fracture Healing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pelvic Fracture
Keywords: Fracture Healing
Teriparatide
Forteo
Pelvic Fractures
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: National Institutes of Health (NIH)
First posted: 2008-01-16
Enrollment: 10
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of the drug teriparatide to the effect of placebo on pelvic fracture healing.

Detailed description: Teriparatide is a man-made form of a naturally occurring hormone called parathyroid. It increases bone density and bone strength to help prevent fractures and can be used to treat osteoporosis in people who have a high risk of bone fracture. The purpose of this study is to compare the effect of teriparatide to the effect of placebo on pelvic fracture healing.

This study will last 16 weeks. Participants will be randomly assigned to receive either teriparatide or placebo for the duration of the study. Participants will also be given calcium and vitamin D supplements to take daily throughout the study. At 4-week intervals, participants will undergo functional evaluations that will include the instrumented sit-to-stand test, the timed-up-and-go, and a gait velocity test. Participants will also undergo a DXA scan upon enrollment; undergo a CT evaluation upon enrollment and 16 weeks post-fracture; and complete specific pain, self-perceived function, mental status, and depression scales throughout the study.

Eligibility criteria: Inclusion Criteria:

* Females must be menopausal (no menses within the last 12 months)
* Low energy fragility fractures of the pelvis, including anterior column, posterior column, inferior or superior rami, or sacrum
* Maximum of 2 weeks post fracture
* Mental status consistent with completing the study protocol

Exclusion Criteria:

* Currently receiving any treatment for osteoporosis, including estrogen and estrogenic-like compounds
* Received radiation treatment to any site at any time in the past
* Received chemotherapy for cancer at any time in the past
* Any active cancer
* Surgical repair (or attempted repair) of the fracture site in the pelvis
* Use of any bone-active medications
* Use of anticonvulsant therapy
* Use of immunosuppressants
* Any renal, gastrointestinal, liver, or metabolic bone disease
* Pregnancy
* High calcium, parathyroid hormone, or alkaline phosphatase, as based on laboratory results

Primary outcomes:
measure: Healing of a Fracture From a Low Energy Fall
timeFrame: Measured at 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: J.Edward Puzas, PhD
role: PRINCIPAL_INVESTIGATOR
References: