Study to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass

What Was Tested

The trial (phase 2) is built around Teriparatide for osteoporosis and bone density.

This study is being conducted to evaluate the effect treatment has on serum P1NP levels, a biomarker of bone formation in postmenopausal women with low bone mass.

It had five arms (groups): one (experimental), one (experimental), one (experimental), Forteo (active comparator) and Placebo Nasal Spray (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

130 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: Postmenopausal Females Age ≥ 45 years. Weight \> 45 kg and \< 90 kg. Normal nasal examination at baseline.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: serious medical condition; history of diseases which affect bone metabolism other than postmenopausal osteoporosis such as paget's disease, any secondary causes of osteoporosis, hypoparathyroidism, or hyperparathyroidism; have a history of cancer within the past 5 years, except for basal cell carcinoma.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-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.

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

Blinding on both sides kept the osteoporosis and bone density participants and researchers unaware of who received Teriparatide.

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

It started in 2011-11 with completion listed for 2012-07.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Serum P1NP from baseline to end of treatment (time frame: 6 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 130 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.