A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women

What Was Tested

In this phase 3 trial, researchers set out to test Calcitonin.

Osteoporosis is the term used to describe a large group of diseases, which are characterized by loss of bone density, which makes the bones weaker.

Osteoporosis often occurs in postmenopausal women.

It had three arms (groups): Oral calcitonin and placebo nasal spray (experimental), Intranasal calcitonin & oral placebo (active comparator) and Placebo: tablet & intranasal spray (placebo comparator).

Intervention: Oral calcitonin tablet (along with placebo intranasal spray).

Intervention: Commercially available, active comparator, intranasal calcitonin-salmon (plus matching oral placebo tablet).

Intervention: Both oral matching placebo tablets and matching intranasal placebo spray.

The registry classes the interventions as drug.

More on the Plan

Women age 45 and over who were postmenopausal and had a diagnosis of osteoporosis were eligible for the study and were randomly allocated to one of three treatment groups; placebo tablets, oral rsCT tablets or calcitonin nasal spray.

The study medication and supplements were self-administered at home.

It was anticipated that approximately 545 patients would participate in the study.

CTx-1 and N-telopeptide of collagen 1 (NTx-1), biochemical markers of bone resorption and total Procollagen type 1 N-terminal propeptide (P1NP),a marker of bone formation, were assessed at Week 0, Week 24, and Week 48.

Who Took Part

The registry lists 565 actual participants took part.

It was open to women only aged from 45 years with no upper age limit.

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

Examples of who could join: Female and age 45 or over.

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: history of severe allergic disease; history of metabolic and other bone diseases, including osteogenesis imperfecta, osteomalacia, and paget's disease; vitamin d insufficiency defined as a 25 hydroxyvitamin d level \<20 ng/ml.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Calcitonin, so expectations could not easily colour the readings.

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

It started in 2009-06 with completion listed for 2011-02.

It ran at 20 sites in United States (9), United Kingdom (7), Bulgaria (1), Hungary (1), Poland (1) and South Africa (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine (time frame: 48 weeks).

It also tracked 2 secondary outcomes, for example Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1) and Change in Plasma CTx-1 From Baseline.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Calcitonin in 565 people.

With 565 participants it is a large trial for this field.

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

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