Second Study of the Effect of Teriparatide on Hip Fracture Healing

What Was Tested

In this phase 3 trial, researchers set out to test Teriparatide.

The study will enroll men and postmenopausal women at least 50 years of age with a recent hip (femoral neck) fracture caused by low-trauma (for example, fall from standing height or less).

It had two arms (groups): Placebo (placebo comparator) and Teriparatide (experimental).

Administered once daily by subcutaneous (SC) injection for 6 months.

The registry classes the interventions as dietary supplement and drug.

More on the Plan

This is a 12-month, Phase 3, prospective, randomized, parallel, double-blind, placebo-controlled, multicenter, multinational study to evaluate the effect of 6 months of treatment with teriparatide on fracture healing in participants who have sustained a recent low-trauma, unilateral, femoral neck fracture stabilized by internal fixation.

The study has 3 periods: 1.

A screening period that must be completed in ≤ 14 days after operative treatment of the femoral neck fracture 2.

A 6-month double-blind treatment period \[teriparatide 20 (µg) or placebo given once daily by subcutaneous injection\] 3.

Who Took Part

39 actual participants took part.

It was open to people of any sex aged from 50 years with no upper age limit.

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

Examples of who could join: Community dwelling men and postmenopausal women who were ambulatory before sustaining a low-trauma, unilateral femoral neck fracture (displaced or nondisplaced). Other than femoral neck fracture, be free of incapacitating conditions and have a life expectancy of at least 2 years. Have given written informed consent (participant or proxy) after being informed of the risks, medications, and study procedures.

The full record lists 4 inclusion and 20 exclusion criteria; among the exclusions: history of unresolved skeletal diseases affecting bone metabolism other than primary osteoporosis; abnormally elevated serum calcium at screening; abnormally elevated serum intact parathyroid hormone (pth) (1-84) at screening.

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.

The Teriparatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Teriparatide.

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

It started in 2012-01 with completion listed for 2013-11.

It ran at 75 sites in United States (19), Germany (9), Belgium (6), Hungary (6), India (6) and Croatia (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture (time frame: 12 months).

It also tracked 13 secondary outcomes, for example Percentage of Participants With Radiographic Evidence of Healing, Percentage of Participants With Pain Control During Ambulation, Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit, Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing, Percentage of Participants With Functional Evidence of Healing and Percentage of Participants Able to Ambulate.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teriparatide in 39 people.

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, all human trials.