Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis

What Was Tested

In this phase 4 trial, researchers set out to test Teriparatide for osteoporosis and bone density.

The purpose of this study is to determine how teriparatide or denosumab affects the bone of postmenopausal women with osteoporosis after 3 months of treatment, as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis).

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 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 (no vaginal bleeding for at least 2 years prior to screening) with osteoporosis. Laboratory values for serum calcium, parathyroid hormone (PTH), and alkaline phosphatase must be within the normal reference range.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: has a history of exposure to dem or tet therapy in the 12 months prior to screening or a known allergy to dem or tet; has undergone 2 previous iliac crest bone biopsies (1 in each iliac crest); has a 25-hydroxyvitamin d concentration of \<10 nanograms per milliliter (ng/ml).

How the Study Was Run

Design: 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.

Groups ran in parallel: each of the osteoporosis and bone density participants stayed in one arm throughout.

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.

It started in 2013-01 with completion listed for 2014-06.

It ran at 6 sites in United States (4) and Canada (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline to 3 Months in Mineralizing Surface (MS) /Bone Surface (BS) in the Cancellous Compartment (CC) of the Iliac Crest Bone Biopsies.

It also tracked 21 secondary outcomes, for example Percentage of Bone With Remodeling-Based and Modeling-Based Formations in the CC, EC and PC of the Iliac Crest Bone Biopsies, Percentage of Overfilled Remodeling Sites in the CC, EC and PC of the Iliac Crest Bone Biopsies, Change From Baseline to 3 Months in Mineral Apposition Rate (MAR) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies, Change From Baseline to 3 Months in Bone Formation Rate/Bone Surface (BFR/BS ) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies, Percentage Change From Baseline to 1, 3, and 6 Months in Intact Parathyroid Hormone (PTH) and Percentage Change From Baseline to 1, 3, and 6 Months in Serum Procollagen Type I N-terminal Propeptide (P1NP).

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.