Bone Loss, Osteoporosis, Spinal Cord Injury
Conditions
Brief summary
Individuals with spinal cord injury sustain significant loss of bone mass in their lower extremities (20-40% or more). This study evaluates the ability of PTH and weight-bearing, two interventions that build bone, to increase bone mass in this population.
Detailed description
This pilot project aims to evaluate PTH with weight-bearing in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 12 people with SCI will be enrolled into a 6 month study assessing the effects of a weight-bearing regime plus daily PTH (Forteo 20ug sc) on BMD and bone markers. Subjects will be evaluated at 3 and 6 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption. An optional extension to 12 months will be offered to all subjects.
Interventions
DRUGteriparatide
teriparatide 20ug daily sc for 6 months
OTHERweight-bearing
device assisted walking
Sponsors
Eli Lilly and Company
Shirley Ryan AbilityLab
Thomas J. Schnitzer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75 years 2. Complete SCI - total loss of motor function below level of lesion 3. Capable of positioning to have DEXA performed 4. Capable of undertaking the weight-bearing exercise regime 5. Capable of reading and understanding informed consent document 6. Able to self-administer PTH or have someone in the family who can do so 7. T score \<-2.5 or Z score \<-1.5 on evaluation of total hip BMD 8. No known endocrinopathies 9. Normal TSH levels 10. Normal 25-OH vitamin D levels 11. Normal calcium levels 12. Normal renal function (creatinine \<2.0mg/dl) 13. Able to return for all follow-up visits
Exclusion criteria
1. Surgical or other intervention resulting in metal or anatomy precluding obtaining DEXA and/or MRI measurements 2. Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study 3. History of malignancy 4. History of radiation therapy 5. Unable to self-administer PTH or have it administered 6. Elevated liver function tests \>2x normal 7. For males, significantly abnormal free testosterone levels 8. Currently being prescribed anti-convulsants 9. Currently being prescribed glucocorticoids, other than inhaled glucocorticoids 10. Currently being prescribed any bone-active agents, including any bisphosphonate, raloxifene, hormone therapy (estrogen and estrogen/progestin), calcitonin or strontium-containing compounds. 11. No previous history of bisphosphonate use 12. No previous use of other bone-specific agents during past 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMD at Left Total Hip | Baseline to 6 months | Bone mineral density (gm/cm2) of the total hip region of interest on the left |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| P1NP | Baseline to 6 months | amino-terminal propeptide of type I collagen (P1NP) |
Countries
United States
Participant flow
Recruitment details
Recruitment from outpatient clinic at rehab hospital
Participants by arm
| Arm | Count |
|---|---|
| PTH/Weight-Bearing PTH 20ug/day plus assisted weight-bearing of one hour 3x/week | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | PTH/Weight-Bearing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age Continuous | 34.0 years STANDARD_DEVIATION 7.8 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
BMD at Left Total Hip
Bone mineral density (gm/cm2) of the total hip region of interest on the left
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTH/Weight-Bearing | BMD at Left Total Hip | 0.02 % change in BMD (gm/cm2) from baseline | Standard Deviation 2.21 |
Secondary
P1NP
amino-terminal propeptide of type I collagen (P1NP)
Time frame: Baseline to 6 months
Population: Only 8 of the total 12 participants enrolled had serum available for testing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTH/Weight-Bearing | P1NP | 61.4 % change from baseline | Standard Deviation 99.3 |