The Effects of Ibandronate or Teriparatide Therapy on Bone Histology and Biochemical Indices in Patients on Hemodialysis With Low Bone Mineral Density

Plain-language guide to NCT00446589: phase 4 non-randomized trial of Teriparatide, osteoporosis and bone density, 19 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00446589
Phase: phase 4
Status: terminated early
Start: 2006-07
Completion (planned or actual): n/a
Participants: 19 (actual)
Design: non-randomized, open label (everyone knows who gets what), treatment
Conditions studied: Osteoporosis
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Teriparatide for osteoporosis and bone density.

A second bone biopsy at the end of the study.

It had two arms (groups): F (experimental) and I (experimental).

HD pts suffering from osteoporosis and adynamic bone disease who received teriparatide.

Hemodialysis pts suffering from osteoporosis who received iv ibandronate.

The registry classes the interventions as drug.

Who Took Part

The registry lists 19 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Bone mineral density (T-score\<-2.5). Adynamic bone disease for the teriparatide group.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: suspected carcinoma; unstable clinical setting.

How the Study Was Run

Design: non-randomized, single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2006-07.

It ran at 1 site in Greece.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients (time frame: one year).

It also tracked 1 secondary outcome, for example Effects of ibandronate and teriparatide on other bone disease markers.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Teriparatide in 19 people with osteoporosis and bone density.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Teriparatide: A parathyroid hormone fragment, PTH(1-34), with human trials and approved-pen labeling; the research vial is not the approved pen.

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.