Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover

What Was Tested

In this phase 4 trial, researchers set out to test Teriparatide for osteoporosis and bone density.

Current treatment options do not account for differences between age-related and estrogen deficiency related osteoporosis, because of the need for bone biopsies for determination.

It had three arms (groups): Group 1 Low Turnover (active comparator), Group 2 Low Turnover (active comparator) and Group 3 Normal-High Turnover (active comparator).

Teriparatide (anabolic) For 1 Year.

Standard of Care - Control: Treated with Alendronate (antiresorber) For 1 Year.

Standard of Care Treatment with Alendronate (antiresorber) For 1 Year.

The registry classes the interventions as drug.

More on the Plan

Osteoporosis is a health problem of major proportions.

Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined.

Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored.

Who Took Part

60 planned participants were the target.

It was open to people of any sex aged from 40 years with no upper age limit.

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

Examples of who could join: Diagnosed Osteoporosis by DXA (BMD t-score ≤ -2.5 with or without fragility fractures). Treatment naive with respect to with anabolic or antiresorptive bone drugs. Premenopausal, menopausal, and post-menopausal females. 45 years old and older. Presence or absence of diabetes.

The full record lists 7 inclusion and 17 exclusion criteria; among the exclusions: pregnant or trying to become pregnant or are breastfeeding; participation in a study of an investigational drug during the past 30 days; treatment with anabolic or antiresorptive bone drugs.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Nothing was hidden in this open-label Teriparatide study: the osteoporosis and bone density participants and staff both knew the treatment.

It started in 2022-03-21 with completion listed for 2027-01-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mineral Bone Density of the lumbar spine (time frame: 1 Year). Measure of serum osteocalcin levels to predict bone turnover (time frame: 1 Year).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 60 people with osteoporosis and bone density.

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

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