Novel Combination Therapy for Osteoporosis in Men

What Was Tested

This registered phase 4 trial tested Teriparatide.

Osteoporotic fractures are a key health problem in older men.

TPTD is a potent bone anabolic drug, meaning that it builds bone mass.

It had two arms (groups): Combination Therapy Arm: Teriparatide (TPTD) + the Calcimimetic Cinacalcet (experimental) and Monotherapy Arm: Teriparatide (TPTD) + Placebo (placebo comparator).

The registry classes the interventions as dietary supplement and drug.

More on the Plan

NOVEL COMBINATION THERAPY FOR OSTEOPOROSIS IN MEN 1.

Background for the Study What Is the Risk of Osteoporotic Fractures in Men and Why Do Men Lose Bone Mass?

Osteoporosis is a neglected condition in men.

Estimated costs are at least $20 billion annually.

Who Took Part

The registry lists 40 actual participants took part.

It was open to men only aged from 60 years up to 85 years.

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

Examples of who could join: At least 2 LS vertebral levels with reliable BMD values (i.e., at least 2 without compression or hardware).

The full record lists 2 inclusion and 21 exclusion criteria; among the exclusions: metabolic bone disease other than osteoporosis (e.g., paget's disease, hyperparathyroidism); 25 oh vitamin d levels \<20 ng/ml or \>80 ng/ml at screening; cancer within past 5 years except for non-melanomatous skin cancers.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.

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

Blinding on both sides kept the participants and researchers unaware of who received Teriparatide.

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

It started in 2019-07-01 with completion listed for 2025-06-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Effects of Treatment With TPTD+Cinacalcet Compared to TPTD+PBO on Lumbar Spine BMD in Men With Low Bone Mass (time frame: 48 weeks).

It also tracked 2 secondary outcomes, for example Effects of Treatment With TPTD+Cinacalcet Compared to TPTD+PBO on Serum P1NP in Men With Low Bone Mass and Effects of Treatment With TPTD+Cinacalcet Compared to TPTD+PBO on Femoral Neck BMD in Men With Low Bone Mass.

What This Means in Plain Language

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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