Clinical trial NCT00826228: Effect of Parathyroid Hormone (PTH) and Weight-Bearing on Bone in Spinal Cord Injury (SCI)
Official title: Effect of PTH Combined With Weight-Bearing on Bone Density and Bone Architecture in People With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Bone Loss
Spinal Cord Injury
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Shirley Ryan AbilityLab
First posted: 2009-01-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: BMD at Left Total Hip
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: P1NP
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
Study officials:
affiliation: Northwestern University
name: Thomas J Schnitzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: