Chronotherapeutic Optimization of Teriparatide Administration in Postmenopausal Osteoporosis

What Was Tested

In this not phased trial, researchers set out to test Teriparatide.

This is a randomized, controlled, and exploratory study designed to evaluate the chronotherapeutic effects of teriparatide administration in postmenopausal osteoporosis.

It had two arms (groups): Morning (8:00) administration group of teriparatide (experimental) and Evening (20:00) administration group of teriparatide (experimental).

The registry classes the interventions as behavioral.

More on the Plan

Subjects who meet the inclusion and exclusion criteria can be enrolled in this trial after signing the informed consent form.

Each trial group plans to enroll 14 subjects, with a total of 28 subjects.

The specific time of drug administration for each patient every day needs to be recorded in the diary card.

Who Took Part

Enrollment: 28 planned participants were the target.

It was open to women only aged from 60 years up to 70 years.

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

Examples of who could join: Aged 60-70 years (inclusive). Naturally postmenopausal women with≥5 years since last menses. DXA-measured BMD T-score≤-3.0 at lumbar spine (L1-L4) and/or total hip at screening. The concentration of 25-hydroxyvitamin D (25-OH)D is ≥20 ng/ml. If the subject meets all other inclusion and.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: normal-range serum parameters:; subjects with bone metabolic diseases besides osteoporosis:; other metabolic bone diseases, such as osteomalacia, osteogenesis imperfecta, paget's disease；.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Being open-label, the Teriparatide study did not mask who received what.

It started in 2025-05-01 with completion listed for 2025-12-30.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change of CTX from baseline after administration (time frame: Within 12 weeks). Change of P1NP from baseline after administration (time frame: Within 12 weeks). Change of PTH from baseline after administration (time frame: Within 12 weeks).

It also tracked 1 secondary outcome, for example Safety Evaluation.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Teriparatide in 28 people.

Its size is small, so on its own it can only give an early look.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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