Use of Teriparatide to Accelerate Fracture Healing

• Sponsor: University of Rochester (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00594906
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH), National Institutes of Health (NIH) (NIH)
• Enrollment: 10
• Location: 1
• Arms: 2
• Duration (Months): 54
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Fracture	Drug: Teriparatide; Drug: Placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Use of Teriparatide to Accelerate Fracture Healing
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Injection 30 participants will receive teriparatide (Forteo) injection pens.	Drug: Teriparatide; Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks); Other Names: Forteo
Placebo Comparator: Placebo 30 participants will receive placebo injection pens.	Drug: Placebo; Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)

Outcome Measures

Primary Outcome Measures

1. Healing of a Fracture From a Low Energy Fall [Measured at 16 weeks]

   Callus formation at the fracture site as defined by a CT scan to determine healing (early/beginning callus formation) or healed (complete callus formation)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: J.Edward Puzas, PhD, University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Edward Puzas, Dr., University of Rochester
• ClinicalTrials.gov Identifier: NCT00594906
• Other Study ID Numbers: P50AR054041; P50AR054041
• First Posted: Jan 16, 2008
• Last Update Posted: Dec 19, 2014
• Last Verified: Mar 1, 2013

• Keywords provided by Edward Puzas, Dr., University of Rochester: Fracture Healing; Teriparatide; Forteo; Pelvic Fractures
• Additional relevant MeSH terms: Fractures, Bone; Hip Fractures; Teriparatide

Study Results

Participant Flow

Arm/Group Title	Forteo Injection	Placebo Injection
Arm/Group Description	30 participants will receive teriparatide (Forteo) injection pens. Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)	30 participants will receive placebo injection pens. Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
Period Title: Overall Study
STARTED	7	3
COMPLETED	6	1
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Injection	Placebo	Total
Arm/Group Description	30 participants will receive teriparatide (Forteo) injection pens. Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)	30 participants will receive placebo injection pens. Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)	Total of all reporting groups
Overall Participants	7	3	10
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 28.6%	1 33.3%	3 30%
>=65 years	5 71.4%	2 66.7%	7 70%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	78 (14)	66 (5)	75 (13)
Sex: Female, Male (Count of Participants)
Female	7 100%	3 100%	10 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	7 100%	3 100%	10 100%

Outcome Measures

1. Primary Outcome

Title	Healing of a Fracture From a Low Energy Fall
Description	Callus formation at the fracture site as defined by a CT scan to determine healing (early/beginning callus formation) or healed (complete callus formation)
Time Frame	Measured at 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Patients	Forteo Patients
Arm/Group Description	Patients who recieved Placebo injections.	Patients who recieved Forteo Injections.
Measure Participants	3	7
Healed	0 0%	1 33.3%
Healing	1 14.3%	4 133.3%
Did not compelte CT scan	2 28.6%	2 66.7%

Adverse Events

Arm/Group Title	Forteo Injection		Placebo Injection
Arm/Group Description	Patients who randomized to the study drug, Forteo		Patients who were randomized to Placebo
All Cause Mortality
	Forteo Injection		Placebo Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Forteo Injection		Placebo Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Forteo Injection		Placebo Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/7 (14.3%)		0/3 (0%)
General disorders
Fall	1/7 (14.3%)	1	0/3 (0%)	0

Limitations/Caveats

Early termination leading to small numbers of subjects analyzed.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.