12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)

What Was Tested

In this phase 2 trial, researchers set out to test Teriparatide for osteoporosis and bone density.

It had 1 arm (groups): Teriparatide and vibration (experimental).

The registry classes the interventions as device and drug.

More on the Plan

This extension study will only enroll individuals who have completed one year of treatment in the parent protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury (NCT01225055)".

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

Who Took Part

Enrollment: 25 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: Enrollment in, and completion of one year of treatment, in protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury". A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:. Has not undergone a hysterectomy or bilateral oophorectomy; or. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). Ability to understand and the willingness to sign a written informed consent.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: individuals who could not tolerate teriparatide treatment; individuals who will not be able to return for all study visits; patients may not be receiving any other investigational agents.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Teriparatide study: the osteoporosis and bone density participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-01 with completion listed for 2015-08-14.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA) (time frame: Baseline to 24 months).

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

What This Means in Plain Language

Put simply, this is a phase 2 trial of Teriparatide in 25 people with osteoporosis and bone density.

Its size is small, so on its own it can only give an early look.

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.