Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture

What Was Tested

The trial (not phased) is built around Teriparatide.

This project anchors osteoporotic fractures, conduct registration and follow-up studies, and conduct prospective treatment studies.

It had two arms (groups): one (active comparator) and Teriparatide was sequentially treated with Denosumab (experimental).

The registry classes the interventions as drug.

Who Took Part

2478 planned participants were the target.

It was open to people of any sex aged from 45 years up to 90 years.

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

Examples of who could join: New brittle hip fractures;. New brittle vertebral fractures;. New other site fractures and/or total hip or neck of femur or L1-L4 T-value \< -1.0;. Men or postmenopausal women;. Age 45-90 years old;.

The full record lists 6 inclusion and 19 exclusion criteria; among the exclusions: bone metabolic diseases except for osteoporosis eg. a. (osteogenesis imperfecta, paget's disease, osteomalacia), b. cushing's syndrome, c.hyperprolactinemia;; having primary hyperparathyroidism or hypothyroidism;; had or have osteomyelitis of the jaw or necrosis of the jaw;.

How the Study Was Run

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

The 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.

Only one side, usually the participants, was kept unaware of whether Teriparatide was given.

Those kept unaware of assignments: participant.

It started in 2023-05-26 with completion listed for 2026-09-30.

It ran at 58 sites in China (58).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The main study：The incidence of new vertebral fractures (time frame: Within 24 months of treatment). The sub study：The rate of change in BMD from baseline at lumbar spine in 24 months (time frame: Within 24 months of treatment).

It also tracked 10 secondary outcomes, for example The main study：New vertebral fractures in 12 months, The main study：New hip fractures, new fractures at other sites, and all new fractures at 12 and 24 months, The main study：The rate of BMD change from the baseline at the lumbar spine, total hip, and femoral neck in 12 and 24 months;, The main study：The patients' adherence to treatment, The sub study：BMD change at lumbar spine in 12 months and The sub study：BMD changes at total hip and femoral neck in 12 and 24 months.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Teriparatide in 2478 people.

With 2478 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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