Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury

What Was Tested

This registered phase 2 trial tested Teriparatide for osteoporosis and bone density.

Spinal cord injury (SCI) results in marked acute loss of bone.

This study evaluates the effect of teriparatide (PTH) and the use of vibration as a form of mechanical stimulation on bone mass.

It had three arms (groups): Teriparatide (experimental), Vibration (experimental) and Teriparatide and vibration (experimental).

Teriparatide alone with sham vibration.

Vibration alone with placebo-teriparatide.

Teriparatide with vibration applied in conjuction.

The registry classes the interventions as device and drug.

More on the Plan

The aim of this study is to evaluate PTH with vibration in a group of individuals with chronic SCI and loss of bone mass in their lower extremities.

Subjects will be evaluated at 3, 6, 9, and 12 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption.

Who Took Part

The registry lists 60 actual participants took part.

It was open to people of any sex aged from 21 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Both males and females. SCI with inability to ambulate independently. Capable of positioning to have DXA performed. Low bone mass at the total hip by DEXA (Z score \< 1.5; T score \< 2.5 or T score \<-2.0 plus preexisting fragility fracture). Capable of reading and understanding informed consent document.

The full record lists 12 inclusion and 15 exclusion criteria; among the exclusions: had had an allergic reaction to teriparatide (forteo) or one of its ingredients; have paget's disease of the bone; have unexplained high levels of f alkaline phosphatase in blood.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the osteoporosis and bone density participants stayed in one arm throughout.

Neither the osteoporosis and bone density participants nor the staff measuring them knew who was on Teriparatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2010-10 with completion listed for 2015-08.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Bone Mineral Density BMD of the Total Hip as Assessed by DXA (time frame: Baseline to 12 Months).

It also tracked 5 secondary outcomes, for example Bone Mineral Density (BMD) by DXA at the Lumbar Spine, Bone Mineral Density (BMD) by DXA at Femoral Neck, C-terminal Telopeptide, Bone-specific Alkaline Phosphatase and Amino-terminal Propeptide of Type 1 Collagen.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 60 people with osteoporosis and bone density.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Teriparatide compound page, Osteoporosis and bone density research.