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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT00826228 (opens ClinicalTrials.gov in a new tab)Other idSTU00003009
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
12 participants (actual)
Sponsor
Thomas J. Schnitzer · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jun 2009
Primary completion
Mar 2012
Completion
Dec 2012
First posted
22 Jan 2009 (estimated)
Last update posted
11 Jul 2013 (estimated)
Conditions
Osteoporosis · Bone Loss · Spinal Cord Injury

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20092010201120122013
  1. Ph 4

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

    NCT00826228

    Jun 2009 to Dec 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • teriparatideDrug
  • weight-bearingOther

Arms1

  • Experimental

    PTH/Weight-Bearing

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. BMD at Left Total Hip

    Time frame · Baseline to 6 months

    Registry description

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

Secondary outcomes(1)

  1. P1NP

    Time frame · Baseline to 6 months

    Registry description

    amino-terminal propeptide of type I collagen (P1NP)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline to 6 months

BMD at Left Total Hip

GroupValue (% change in BMD (gm/cm2) from baseline)Spread
PTH/Weight-Bearing0.022.21
Secondary and other outcome results(1)
Secondary outcomeMean· Baseline to 6 months

P1NP

GroupValue (% change from baseline)Spread
PTH/Weight-Bearing61.499.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PTH/Weight-BearingPTH 20ug/day plus assisted weight-bearing of one hour 3x/week–0 / 121 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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