Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women

What Was Tested

In this phase 2 trial, researchers set out to test Teriparatide.

Idiopathic osteoporosis (IOP) is defined as osteoporosis that affects young, otherwise completely healthy individuals with no secondary cause of bone loss.

Additionally, using noninvasive high resolution imaging of the central and peripheral skeleton and detailed analyses of transiliac crest bone biopsies, the investigators identified several features of bone quality in premenopausal women with IOP.

It had two arms (groups): Teriparatide (Forteo) (active comparator) and Placebo saline injection (placebo comparator).

Daily injection of Teriparatide for treatment of idiopathic osteoporosis.

Daily injection of saline placebo for 6 months, followed by 24 months of teriparatide treatment for idiopathic osteoporosis.

The registry classes the interventions as drug.

More on the Plan

Osteoporosis affects postmenopausal women and elderly men and is very unusual in healthy individuals under age 50.

Idiopathic osteoporosis (IOP) is defined as osteoporosis that affects young, otherwise completely healthy individuals with intact gonadal function and no secondary cause of bone loss.

First described by Fuller Albright in 1944, IOP is an uncommon condition with an estimated annual incidence of 0.4 cases per 100,0003.

IOP predominantly affects Caucasians, who generally present in their mid-30s with one more low trauma fractures.

Who Took Part

Enrollment: 41 actual participants took part.

It was open to women only aged from 20 years up to 45 years.

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

Examples of who could join: Premenopausal women, aged 20-45, with regular menses and no historical or biochemical secondary cause of osteoporosis. Documented adult fractures judged to be low-trauma. Premenopausal women ages 20-35 years must have at least one major osteoporotic fracture (excluding fractures of fingers, toes and face) and low Bone Mineral Density (BMD). Premenopausal women above the age of 35 years should have a history of fracture and/or low BMD.

The full record lists 5 inclusion and 18 exclusion criteria; among the exclusions: early follicular phase serum; disorders of mineral metabolism; suspicion of osteomalacia.

How the Study Was Run

Design: randomized, crossover 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.

Each person switched between Teriparatide and the comparison at some point, usually with a gap in between.

As a double-blind Teriparatide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2012-08-02 with completion listed for 2018-01-01.

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

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Lumbar Spine Bone Mineral Density (LS-BMD) on Active Medication (time frame: Baseline and 12 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 41 people.

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.