Early Effects of Parathyroid Hormone (PTH) on the Proximal Femur

What Was Tested

The trial (not phased) is built around Teriparatide.

The investigators will evaluate hip bone samples from patients treated with teriparatide before undergoing hip replacement.

It had two arms (groups): teriparatide (active comparator) and placebo (placebo comparator).

Six weeks of teriparatide.

Placebo identical in appearance to teriparatide.

The registry classes the interventions as drug and other.

More on the Plan

Osteoporosis with consequent hip fractures causes substantial disability, morbidity and mortality.

Both biochemical and histomorphometric investigations of the iliac crest at very early time points (within 4-6 weeks of administration) show that bone formation is dramatically stimulated.

The current study will provide evidence for or against this possible TPTD-induced periosteal expansion.

From a clinical perspective, it is unclear whether TPTD would be preferable to other osteoporosis medications, such as zoledronic acid, in patients at high risk for hip fracture.

Who Took Part

40 actual participants took part.

It was open to people of any sex aged from 50 years up to 90 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age 50-90 years old. Male or postmenopausal (women who have had no menses for one year).

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: any contraindications to use of tptd; age younger than 50, greater than 90 years old; metabolic bone disease other than osteoporosis.

How the Study Was Run

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

Because people in this Teriparatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the 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, investigator and outcomes assessor.

It started in 2010-08 with completion listed for 2014-11.

It ran at 1 site in United States.

What Was Measured

The main thing measured (primary outcome): Bone formation rate (time frame: 6 weeks).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Teriparatide in 40 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teriparatide compound page, all human trials.