G56W1 in Women With Postmenopausal Osteoporosis

What Was Tested

This registered phase 1, phase 2 trial tested Teriparatide.

It had three arms (groups): one (experimental), one (experimental) and teriparatide acetate(Teribone™) (active comparator).

The registry classes the interventions as biological.

Who Took Part

148 planned participants were the target.

It was open to people of any sex aged from 45 years up to 75 years.

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

Examples of who could join: Female, capable of self - motivation , 45 years old ≤ age ≤ 75 years old. Weight ≥ 40kg , 18 ≤ body mass index(BMI)≤ 30 . Meets one of the following diagnostic criteria for osteoporosis, and ≥ 3 vertebral bodies of L1-4 can be measured by bone mineral density using the DXA method. Brittle fracture of the hip or vertebral body, and the bone density measurement T- score\< -1.0. The T- score of the central axis bone mineral density or the 1/3 bone density of the distal radius of the tibia was ≤-2.5 measured by DXA .

The full record lists 8 inclusion and 27 exclusion criteria; among the exclusions: secondary osteoporosis, such as osteomalacia, rheumatoid arthritis, gout, multiple myeloma, etc; severe lumbar anatomical abnormalities which affecting dxa bone mineral density measurement, such as severe scoliosis; patients who have been treated for anti-osteoporosis before random enrollment:.

How the Study Was Run

Design: 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.

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

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

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

It started in 2018-10-01 with completion listed for 2020-05-31.

It ran at 9 sites in China (9).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The percentage change in bone density of the lumbar spine ( L1-4 ) from baseline to 24 weeks after treatment (time frame: Baseline，week 24).

It also tracked 6 secondary outcomes, for example The percentage change of total hip bone density from baseline to 24 weeks after G56W1 treatment, Maximum plasma concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time to maximum plasma concentration（Tmax） and Elimination half-life（t1/2）.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Teriparatide in 148 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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