Precision Medicine Approach for Osteoporosis - Follow Up Study

What Was Tested

This registered phase 4 trial tested Teriparatide.

Osteoporosis is a health problem of major proportions.

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

It had three arms (groups): Group 1 Low Turnover - crossover (experimental), Group 2 Low Turnover - crossover (experimental) and Group 2 Low Turnover - continuation (experimental).

Alendronate.

Teriparatide.

Alendronate.

The registry classes the interventions as drug.

More on the Plan

This will be a prospective, longitudinal crossover trial for participants who have completed therapy in the main trial - Novel precision medicine approach to treatment of osteoporosis based on bone turnover.

Participants will be informed of the continuation / follow-up study at enrollment into the main trial.

Participants will be approached for further participation in the continuation trial near the end of the initial 12 months treatment period.

Consent will be obtained at the final visit of the main trial and crossover therapy will be initiated at that time.

Who Took Part

The registry lists 40 planned participants were the target.

It was open to women only aged from 45 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). Prior enrollment and completion of therapy in the "Novel precision medicine approach to treatment of osteoporosis based on bone turnover" trial.3) Premenopausal, menopausal, and post-menopausal females. 45 years old and older. Normal levels of Vitamin D. Absence of all.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: pregnant or trying to become pregnant or are breastfeeding; use of systemic anticoagulation (blood thinner); planned or anticipated oral surgery within the next 12 months.

How the Study Was Run

Design: non-randomized, crossover and open-label.

In the crossover set-up each of the participants took both Teriparatide and the comparison in turn, acting as their own control.

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

It started in 2024-02-01 with completion listed for 2029-12-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent change in bone loss (time frame: 12 months).

It also tracked 1 secondary outcome, for example Percent change in Bone Mass Density at the hip.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Teriparatide in 40 people.

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

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