PTH & Ibandronate Combination Study (PICS)

What Was Tested

This registered phase 2, phase 3 trial tested Parathyroid Hormone (PTH 1-84).

This study will test in several innovative ways, several different combinations of PTH and oral monthly ibandronate for the treatment of osteoporosis in postmenopausal women.

The intension is to provide other options for treatment than the current standard 2 year course of drug therapy.

These options may lead to treatment where the two years of therapy are spread over several years.

It had two arms (groups): A: 6 months both + 18 months oral only (active comparator) and B: (3 months injection + 9 months oral) x 2 years (active comparator).

The registry classes the interventions as drug and other.

More on the Plan

This randomized double-blind clinical trial for the treatment of postmenopausal osteoporosis will be conducted and coordinated by study investigators who also participated in the investigator-initiated PaTH study.

Final data analysis will compare the results from this trial with those from the PaTH study.

In the PaTH study, 238 women between 55 and 85 years of age were randomized to receive either: 1.

PTH for 1 year followed by alendronate for 1 year 2.

Who Took Part

The registry lists 44 actual participants took part.

It was open to women only aged from 55 years up to 75 years.

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

Examples of who could join: Aged 55-75 years, inclusive, at randomization. Postmenopausal for \>= 5 years (no menses for at least 5 years). Be willing and able to self-administer daily injections. Signed written consent form.

The full record lists 6 inclusion and 34 exclusion criteria; among the exclusions: history of any iv bisphosphonate use; history of more than 12 month of pth use ever, or any use (\>4 weeks) with the past 12 months; have type 1 or uncontrolled type 2 diabetes mellitus (defined as hemoglobin a1c \> 10.0), or currently using insulin.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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.

Neither the participants nor the staff measuring them knew who was on Parathyroid Hormone (PTH 1-84), so expectations could not easily colour the readings.

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

It started in 2008-05 with completion listed for 2011-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): P1NP (ng/ml) Change From Baseline (time frame: Baseline, 3 months).

It also tracked 1 secondary outcome, for example Change From Baseline in Trabecular Spine vBMD.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Parathyroid Hormone (PTH 1-84) in 44 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.