Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

What Was Tested

This registered phase 2, phase 3 trial tested Teriparatide.

Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young individuals sustain one or more low-trauma fractures.

Teriparatide \[PTH(1-34)\], which is FDA approved for treatment of osteoporosis in men and postmenopausal women, works by stimulating bone formation.

It had 1 arm (groups): Women with Idiopathic osteoporosis (IOP) (experimental).

The registry classes the interventions as drug.

More on the Plan

This is the beginning of the third year of an R01 (AR4989603) investigating the etiology and pathogenesis, as well as the histomorphometric and bone microarchitectural features of IOP in premenopausal women.

This is an open-label study of carefully characterized premenopausal women with IOP who are participating in a NIH-funded study and who have fragility fractures or very low bone density.

Participants in the study will receive 18-24 months of teriparatide and the effects on BMD and microstructure, bone mechanical competence, and bone turnover will be assessed.

Who Took Part

The registry lists 22 actual participants took part.

It was open to women only aged from 20 years up to 48 years.

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

Examples of who could join: Premenopausal women of all races. Ages 20 to 48. Regular menses (at least 8 periods in the last 12 months). FSH \< 20 mIU/ml during the early follicular phase, to exclude women in the perimenopause. Low BMD subjects: DXA BMD T score less than or equal to 2.5 at the LS, total hip, femoral neck or distal radius, who have not had a fracture.

The full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: secondary causes of osteoporosis; recent pregnancy or lactation (within past year); prolonged amenorrhea (\> 6 months) during reproductive years (except during pregnancy or lactation).

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Teriparatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2008-08-20 with completion listed for 2012-01-03.

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 Density by Dual Energy X-ray Absorptiometry (DXA) (time frame: Baseline, Month 18 or 24 reported).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3 trial of Teriparatide in 22 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.