Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women

What Was Tested

The trial (phase 3) is built around Calcitonin.

Calcitonin has been used for many years for treating osteoporosis in postmenopausal women.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 90 actual participants took part.

It was open to women only aged from 45 years up to 70 years.

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

Examples of who could join: Women between age 45-70. Natural or surgical menopause ≥ 1 year. T-Score between 0.0 and -2.49 (spine or proximal femur - total or femoral neck measured by DXA).

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: osteoporosis (t-score ≤ -2.5 in spine or proximal femur - total or femoral neck, measured by dxa); severe vertebral fracture, as identified by screening dxa assessment; any history of metabolic disease, which could affect bone metabolism: hyperparathyroidism, osteogenesis imperfecta, paget's disease, osteomalacia.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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 and investigator.

It started in 2007-01 with completion listed for 2011-10.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Bone micro-architecture evaluated by high resolution p-QCT (time frame: 24 months).

It also tracked 1 secondary outcome, for example Bone turn-over markers.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Calcitonin in 90 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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