Trial Outcomes & Findings for Use of Teriparatide to Accelerate Fracture Healing (NCT NCT00594906)

NCT ID: NCT00594906

Last Updated: 2014-12-19

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Measured at 16 weeks
• Results posted on: 2014-12-19

Participant Flow

Participant milestones

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

Reasons for withdrawal

Measure	Forteo Injection 30 participants will receive teriparatide (Forteo) injection pens. Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)	Placebo Injection 30 participants will receive placebo injection pens. Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
Overall Study Physician Decision	0	1
Overall Study Death	0	1

Baseline Characteristics

Use of Teriparatide to Accelerate Fracture Healing

Baseline characteristics by cohort

Measure	Injection n=7 Participants 30 participants will receive teriparatide (Forteo) injection pens. Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)	Placebo n=3 Participants 30 participants will receive placebo injection pens. Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	78 years STANDARD_DEVIATION 14 • n=5 Participants	66 years STANDARD_DEVIATION 5 • n=7 Participants	75 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	3 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Placebo Patients n=3 Participants Patients who recieved Placebo injections.	Forteo Patients n=7 Participants Patients who recieved Forteo Injections.
Healing of a Fracture From a Low Energy Fall Healed	0 participants	1 participants
Healing of a Fracture From a Low Energy Fall Healing	1 participants	4 participants
Healing of a Fracture From a Low Energy Fall Did not compelte CT scan	2 participants	2 participants

Adverse Events

Forteo Injection

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Forteo Injection n=7 participants at risk Patients who randomized to the study drug, Forteo	Placebo Injection n=3 participants at risk Patients who were randomized to Placebo
General disorders Fall	14.3% 1/7 • Number of events 1	0.00% 0/3

Additional Information

Dr. J. Edward Puzas

University of Rochester

Phone: (585) 275-3664

Email: edward_puzas@urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place