Combined Administration of Teripapartide and Antiresorptive Agents in Postmenopausal Osteoporosis

What Was Tested

The trial (phase 4) is built around Teriparatide.

Antiresorptives influence the balance of bone formation and resorption.

It had three arms (groups): Teriparatide (active comparator), Teriparatide and Raloxifene (active comparator) and Teriparatide and Alendronate (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 125 actual participants took part.

It was open to women only aged from 55 years up to 88 years.

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

Examples of who could join: Ambulatory postmenopausal women at least 55 years of age. Lumbar spine, femoral neck, and total hip evaluable by dual energy x ray absorptiometry (DXA).

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: history of bone metabolic diseases, paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption; abnormal thyroid function at any time in the prior 6 months. patients with chronic hypothyreosis and adequate substitution therapy are permitted; active liver disease (liver enzymes more than three times the upper limit of normal) or clinical jaundice.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Nothing was hidden in this open-label Teriparatide study: the participants and staff both knew the treatment.

It started in 2006-03 with completion listed for 2012-12.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Differences in changes of areal lumbar spine BMD between the three treatment groups (time frame: Evaluation after 9, 12 and 18 months of TPTD).

It also tracked 1 secondary outcome, for example Differences in changes of BMDs and markers of bone turnover among the three treatment groups after 18 months TPTD treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 125 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.