Denosumab and teriparatide transitions in postmenopausal osteoporosis (the DATA-Switch study): extension of a randomised controlled trial

What Was Tested

The paper reports a study of Teriparatide, published as a randomized controlled trial.

In this DATA-Switch study, the researchers aimed to assess the changes in bone mineral density in postmenopausal osteoporotic women who transitioned between treatments.

Why It Was Studied

Nonetheless, no approved therapy is able to restore skeletal integrity in most osteoporotic patients and the long-term use of osteoporosis drugs is controversial.

Thus, many patients are treated with the sequential use of two or more therapies.

Who Took Part

According to the abstract, 94 women were involved.

The age groups tagged for this paper are middle-aged adults and older adults, women only.

In DATA-Switch, women originally assigned to teriparatide received denosumab (teriparatide to denosumab group), those originally assigned to denosumab received teriparatide (denosumab to teriparatide group), and those originally assigned to both received an additional 24 months of denosumab alone (combination to denosumab group).

How the Study Was Run

The design is described as randomized and single-blind.

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.

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

The methods mention a period of 4 years.

Bone mineral density at the spine, hip, and wrist were measured 6 months, 12 months, 18 months, and 24 months after the drug transitions as were biochemical markers of bone turnover.

The primary endpoint was the percent change in posterior-anterior spine bone mineral density over 4 years.

Between-group changes were assessed by one-way analysis of variance in their modified intention-to-treat population.

This study is registered with ClinicalTrials.gov, number NCT00926380.

What Was Measured

PubMed files the paper under topics including Antibodies, Monoclonal, Humanized, Bone Density, Bone Density Conservation Agents, Denosumab, Drug Substitution, Osteoporosis, Postmenopausal and Teriparatide.

What This Means in Plain Language

The paper is a randomized and single-blind study of Teriparatide in 94 women over 4 years.

Results are reported in around 10 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2015 (Lancet (London, England)), a journal based in England.

More context: the Teriparatide compound page, all human trials.