Trial Outcomes & Findings for Effect of Parathyroid Hormone (PTH) and Weight-Bearing on Bone in Spinal Cord Injury (SCI) (NCT NCT00826228)

NCT ID: NCT00826228

Last Updated: 2013-07-11

Results Overview

Bone mineral density (gm/cm2) of the total hip region of interest on the left

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 12 participants
• Primary outcome timeframe: Baseline to 6 months
• Results posted on: 2013-07-11

Participant Flow

Recruitment from outpatient clinic at rehab hospital

Participant milestones

Measure	PTH/Weight-Bearing PTH 20ug/day plus assisted weight-bearing on a Lokomat
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	PTH/Weight-Bearing PTH 20ug/day plus assisted weight-bearing on a Lokomat
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Effect of Parathyroid Hormone (PTH) and Weight-Bearing on Bone in Spinal Cord Injury (SCI)

Baseline characteristics by cohort

Measure	PTH/Weight-Bearing n=12 Participants PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	34.0 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Bone mineral density (gm/cm2) of the total hip region of interest on the left

Outcome measures

Measure	PTH/Weight-Bearing n=11 Participants PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
BMD at Left Total Hip	0.02 % change in BMD (gm/cm2) from baseline Standard Deviation 2.21

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: Only 8 of the total 12 participants enrolled had serum available for testing

amino-terminal propeptide of type I collagen (P1NP)

Outcome measures

Measure	PTH/Weight-Bearing n=8 Participants PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
P1NP	61.4 % change from baseline Standard Deviation 99.3

Adverse Events

PTH/Weight-Bearing

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PTH/Weight-Bearing n=12 participants at risk PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
Musculoskeletal and connective tissue disorders fracture	8.3% 1/12 • Number of events 1

Additional Information

Thomas J Schnitzer

Northwestern University Feinberg School of Medicine

Phone: 3125032315

Email: tjs@northwestern.edu

Results disclosure agreements

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