Once Weekly Parathyroid Hormone for Osteoporosis

What Was Tested

The trial (phase 3) is built around Teriparatide.

Daily parathyroid hormone (PTH) is approved by the FDA for the treatment of osteoporosis.

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

Women will self-administer PTH injections daily for 4 weeks, then once weekly for 48 weeks.

Women will self-administer placebo injections daily for 4 weeks, then once weekly for 48 weeks.

The registry classes the interventions as drug.

More on the Plan

Fractures of the hip, spine, and wrists are most typical, though fractures of the ribs, pelvis, and humerus also occur.

The most common form of osteoporosis is postmenopausal osteoporosis.

PTH was recently approved by the FDA as a daily treatment for osteoporosis.

The currently approved formulation of daily PTH self-injections is practical for only a small proportion of people with osteoporosis.

Who Took Part

The registry lists 50 planned participants were the target.

It was open to women only aged from 45 years up to 70 years.

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

Examples of who could join: Bone mineral density scan with a T-score between -1 and -2. Willing to self-administer injections.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: bone fracture since menopause.

How the Study Was Run

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

The participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.

As a double-blind Teriparatide study, the assignments were hidden from both participants and investigators until the end.

It started in 2003-12 with completion listed for 2005-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Bone mineral density (time frame: Months 6 and 12).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teriparatide in 50 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teriparatide compound page, all human trials.