Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use

What Was Tested

This registered phase 4 trial tested Teriparatide and Parathyroid Hormone (PTH 1-84).

During the second year, the study will also look at whether taking risedronate will preserve the bone thickness created by one year of rhPTH 1-34 treatment.

It had four arms (groups): Group1a-rhPTH&RIS-Placebo(Y1)&RIS(Y2) (active comparator), Group1b-rhPTH&RisendronatePlacebo (active comparator), Group2-rhPTH&Risedronate (active comparator) and Group3-rhPTH-Placebo&Risedronate (active comparator).

The registry classes the interventions as drug.

More on the Plan

The study will be divided into 2 phases.

All study subjects will receive supplemental calcium citrate and Vitamin D during the 2-year study.

In year one subjects will be randomly assigned to receive PTH (subcutaneously daily) or placebo and risedronate tablets or placebo.

In year two, PTH will be stopped and subjects in group 1 will be re-randomized to receive risedronate tablets or placebo.

Who Took Part

60 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: Patient is ambulatory and able to return to the site of the investigation at specified time during the study. The patient is willing to participate in the proposed study as evidenced by signing an informed consent. Women of childbearing age are willing to use 2 forms of contraception during the entire study period. Have at least one analyzable BMD site: lumbar spine and/or proximal femur.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: generalized disease of bone other than related to a rheumatic disease and glucocorticoid-induced osteoporosis including: hyperparathyroidism, hypoparathyroidism, paget's disease of bone; history of drug abuse; previous use of alendronate within 6 months prior to the study.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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

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

Neither the participants nor the staff measuring them knew who was on Teriparatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2005-09 with completion listed for 2009-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Bone Mineral Density (BMD): Examine the Pattern and Effect of BMD Changes at Hip and Spine Measured by DXA Every 6 Months (time frame: BMD changes from year 1 to year 2).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide and Parathyroid Hormone (PTH 1-84) in 60 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 and the Parathyroid Hormone (PTH 1-84) compound page, all human trials.