Study to Evaluate Effect of Intranasal Teriparatide on Bone Mineral Density in Postmenopausal Women With Low BMD

What Was Tested

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

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 350 planned participants were the target.

It was open to women only aged up to 89 years.

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

Examples of who could join: Postmenopausal Female patients up to 89 years, inclusive;. BMI ≤ 35 kg/m2, inclusive;. In good health, determined by medical history and physical examination, as well as normal 12-lead ECG and vital signs;. Have a minimum of two evaluable non-fractured lumbar vertebrae. Have low bone mineral density defined as having a T-score ≤ -2.0 as determined by DXA scan at either the lumbar spine (L1-L4) or total hip.

The full record lists 6 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

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

The osteoporosis and bone density participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.

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

As a double-blind Teriparatide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2008-03 with completion listed for 2009-04.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in bone mineral density of the lumbar spine from baseline to 24 weeks post treatment (time frame: 24 weeks).

It also tracked 3 secondary outcomes, for example Change in bone mineral density from baseline to 12 weeks post treatment, Safety, including hypercalcemia and nasal effects and Change from baseline in bone markers PINP and CTX from baseline to 4, 12 and 24 weeks post treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 350 people with osteoporosis and bone density.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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