Comparison Study of PTHrP and PTH to Treat Osteoporosis

What Was Tested

The trial (phase 2) is built around Teriparatide.

It had three arms (groups): one (experimental), one (experimental) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

Osteoporosis is a metabolic bone disease characterized by low bone mass and structural deterioration of bone tissue.

It results from failure of osteoblasts to form sufficient new bone, from an excessive rate of osteoclastic bone resorption, or from the combination of both processes.

This leads to a decline in the quality of life and an associated loss of independence among the millions of individuals in the United States and worldwide afflicted with the disease.

The antiresorptive include estrogen, calcitonin, selective estrogen receptor modulators, and bisphosphonates.

Who Took Part

The registry lists 105 actual participants took part.

It was open to women only aged from 45 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 45 - 75 year old Caucasian, Hispanic or Asian women. One year post-menopausal if older than 50 years. Three years post-menopausal if between the ages of 45 - 50 years. Body mass index less than or equal to 30. T-scores on screening Dual X-Ray Absorbiometry (DXA) scan between - 2.0 to - 4.5 of lumbar spine or hip.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: bisphosphonate therapy within the last two years; estrogen replacement hormones or serms within last one year; no more than one week of pthrp, pth, or an analog of pth within the last year.

How the Study Was Run

Design: randomized, factorial and single-blind.

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.

In this single-blind Teriparatide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2009-05 with completion listed for 2012-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Procallagen-1 Amino-terminal Peptide (P1NP) (time frame: Baseline, Day 15, Day 30, Day 60, Day 90). Carboxy-terminal Telopeptides of Collagen-1 (CTX) (time frame: Baseline, Day 15, Day 30, Day 60, Day 90).

It also tracked 11 secondary outcomes, for example Changes in Bone Mineral Density of the Lumbar Spine, Changes in Bone Mineral Density of the Total Hip, Changes in Bone Mineral Density of the Femoral Neck, Changes in Bone Mineral Density of the Forearm, Changes in Bone Mineral Density of the Distal 1/3 Radius and Total Serum Calcium (mg/dl).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 105 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.