Cyclic Versus Daily Teriparatide on Bone Mass

What Was Tested

In this phase 2 trial, researchers set out to test Teriparatide for osteoporosis and bone density.

Osteoporosis is a disease that affects millions of individuals in the United States and abroad.

This study will compare continuous versus cyclic treatment with teriparatide combined with alendronate, another drug for osteoporosis, or teriparatide alone in women with osteoporosis.

It had six arms (groups): 1 (experimental), 2 (experimental), 3 (active comparator), 4 (experimental) and 5 (experimental).

Participants in this group will have been treated with alendronate for at least 1 year prior to study entry. Upon study entry, they will continue taking alendronate alone. Biopsies will be performed at Week 7 and then participants in this group will be offered teriparatide as part of Group 2 or 3.

The registry classes the interventions as dietary supplement and drug.

More on the Plan

Teriparatide is a new type of drug for people with osteoporosis who are at high risk of fracture.

Teriparatide stimulates bone remodeling and can correct the underlying architectural and bone mass abnormalities that are characteristic of osteoporosis.

All participants have completed a parent study of two years that included a screening visit with a physical exam, blood draw, x-rays, EKG, and distribution of calcium and vitamin D supplements.

Participants will be separated into two groups according to the treatment they have undergone over the year prior to study entry.

Who Took Part

The registry lists 140 planned participants were the target.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Diagnosis of osteoporosis or T score below -2 plus one or more osteoporosis related fractures. Two measurable vertebrae between L1 and L4. Willing to undergo a single iliac crest biopsy after administration of 4 tetracycline labels.

The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: secondary causes of osteoporosis or presence of a skeletal disorder other than osteoporosis; uses drugs likely to affect skeletal or calcium homeostasis; multiple vertebral fractures or severe degenerative changes with fewer than two evaluable vertebrae.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.

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

In this single-blind Teriparatide study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2005-09 with completion listed for 2016-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Bone density (time frame: 24 and 48 months).

It also tracked 2 secondary outcomes, for example Histomorphometry of iliac crest bone biopsies and HRpQCT (tibia, radius) and QCT (spine and hip)and FEA of these QCT scans.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 140 people with osteoporosis and bone density.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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