The Forteo Alendronate Comparator Trial

What Was Tested

The trial (phase 4) is built around Teriparatide.

The main purpose of this study is to evaluate the effects of teriparatide with those of alendronate on spine bone mineral density (BMD) and other osteoporosis factors in postmenopausal women with osteoporosis.

It had two arms (groups): Teriparatide (experimental) and Alendronate (active comparator).

The registry classes the interventions as dietary supplement and drug.

Who Took Part

The registry lists 203 actual participants took part.

It was open to women only aged from 45 years up to 85 years.

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

Examples of who could join: Postmenopausal women with osteoporosis. Ambulatory, 5 years or more past menopause. BMD T score between -2.5 and -4.0 at the lumbar spine or femoral neck.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: prior treatment with pth or a pth analogue; history of diseases other than postmenopausal osteoporosis that affect bone metabolism; malignant neoplasms within 5 years; carcinoma in situ of the uterine cervix within 1 year.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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.

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

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 and investigator.

It started in 2001-04 with completion listed for 2003-05.

It ran at 20 sites in United States (15), Brazil (2), Mexico (2) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change from Baseline to 18 Months in Lumbar Spine BMD (time frame: Baseline, 18 Months).

It also tracked 12 secondary outcomes, for example Percent Change from Baseline in Lumbar Spine BMD, Percent Change from Baseline in Total Hip and Femoral Neck BMD, Percent Change from Baseline in Trabecular Volumetric BMD at the Lumbar Spine, Percent Change from Baseline in Cortical BMD at the Femoral Neck, Percent Change from Baseline in Trabecular BMD at the Femoral Neck and Percent Change from Baseline in Biochemical Marker -Serum Procollagen I C-Terminal Propeptide (PICP).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 203 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.