Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women

Plain-language guide to NCT00086619: phase 2 randomized trial of Parathyroid Hormone (PTH 1-84), 80 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00086619
Phase: phase 2
Status: completed
Start: 2004-05
Completion (planned or actual): 2009-12
Participants: 80 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Postmenopausal Osteoporosis; Osteoporosis
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested Parathyroid Hormone (PTH 1-84).

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

The study will last 18 months.

Blood, urine, and bone density tests will occur at screening.

In addition, bone density tests by DXA will be performed at Months 0, 6, 12, and 18, and by quantitative CT scans at Months 0 and 18.

Who Took Part

The registry lists 80 actual participants took part.

It was open to women only aged from 46 years up to 85 years.

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

Examples of who could join: Three or more years after menopause. Bone mineral density T-score \< or = -2.0 by dual-energy x-ray absorptiometry (DXA) of vertebrae or femoral neck, or by quantitative computerized tomography (QCT) of vertebral body trabeculae.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: cannot walk without assistance; current alcohol abuse; major psychiatric disorders.

How the Study Was Run

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

The participants were allocated by chance, so the Parathyroid Hormone (PTH 1-84) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Parathyroid Hormone (PTH 1-84) study did not mask who received what.

It started in 2004-05 with completion listed for 2009-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Changes in Indices of Bone Turnover (time frame: Each index of bone turnover was measured at study month 0, 1.5, 3, 6, 7.5, 9, 12, 13.5, 15, and 18).

It also tracked 1 secondary outcome, for example Change in Bone Mineral Density (BMD).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Parathyroid Hormone (PTH 1-84) in 80 people.

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

More context: the Parathyroid Hormone (PTH 1-84) compound page, all human trials.

Our Notes on the Compound

Parathyroid Hormone (PTH 1-84): The 84-amino-acid hormone that raises blood calcium; full-length PTH (Natpara) has been used in hypoparathyroidism. Teriparatide is its 1-34 fragment.

Parathyroid Hormone (PTH 1-84) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.