2-Year Therapy With Teriparatide vs 1-yr Therapy Followed by 1-Year of Raloxifene or Calcium/Vit D in Severe Postmenopausal Osteoporosis

What Was Tested

The trial (phase 4) is built around Teriparatide.

Patients are stratified into 3 subsets: (a) patients who have never received any anti-osteoporosis treatment before; (b) patients who received prior antiresorptive treatment successfully; (c) patients who failed to respond adequately to prior antiresorptive drugs (such as bisphosphonates or raloxifene) in the past.

The registry classes the interventions as drug.

Who Took Part

810 planned participants were the target.

It was open to women only aged from 55 years with no upper age limit.

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

Examples of who could join: Ambulatory women greater or equal to 55 years, at least 2 years postmenopausal. Presence of at least one known and documented preexisting clinical fragility fracture, in the past 3 years.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: current or history of vaginal bleeding or spotting of unknown cause in the 1 year prior to study start; fluorides in the 12 months prior to visit 2.

How the Study Was Run

It was run as a randomized, parallel-group and open-label 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.

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

Being open-label, the Teriparatide study did not mask who received what.

It started in 2002-08 with completion listed for 2005-11.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Lumbar spine BMD after 24 months.

It also tracked 5 secondary outcomes, for example Hip and femoral neck BMD at 24 months, Change in itudinal fracture pattern from 3-year pre-study period to end of the study in all patients who receive teriparatide for 2 years, Change in back pain after 1, 6, 12, and 24 mths and Safety of teriparatide.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 810 people.

With 810 participants it is a large trial for this field.

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.