Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women

What Was Tested

This registered phase 4 trial tested Teriparatide for osteoporosis and bone density.

The purpose of this study is to investigate how teriparatide or zoledronic acid affects the bone of postmenopausal osteoporotic women after 6 months of treatment as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis).

After completing 12 months of treatment all participants are eligible to participate in an additional 12-month open label extension.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 69 actual participants took part.

It was open to women only aged from 55 years up to 89 years.

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

Examples of who could join: Ambulatory, postmenopausal women with osteoporosis (no vaginal bleeding for at least 2 years prior to trial entry). Free of severe or chronically disabling conditions other than osteoporosis that will impair ability to complete the trial. Serum calcium, parathyroid hormone (PTH), alkaline phosphatase must be within normal reference range.

The full record lists 5 inclusion and 16 exclusion criteria; among the exclusions: are allergic or cannot tolerate teriparatide or zoledronic acid or any of their ingredients or components; are allergic to tetracycline; have a history of exposure to tetracycline therapy in the 3 months prior to trial entry.

How the Study Was Run

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

Blinding on both sides kept the osteoporosis and bone density participants and researchers unaware of who received Teriparatide.

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

It started in 2009-07 with completion listed for 2010-10.

It ran at 12 sites in United States (9) and Canada (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months (time frame: 6 months).

It also tracked 55 secondary outcomes, for example Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months, Mineralizing Surface/Bone Surface(MS/BS) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months, Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months, Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months, Activation Frequency (Ac.f) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months and Bone Formation Rate (BFR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 69 people with osteoporosis and bone density.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Teriparatide compound page, Osteoporosis and bone density research.