The Impact of Parathyroid Hormone (PTH) on Craniofacial Osseous Regeneration in Bone

What Was Tested

The trial (phase 2) is built around Teriparatide.

Good bone healing and bone build-up are necessary for the success of dental implants.

Forteo has been approved by the Food and Drug Administration (FDA) for use in patients with a condition where bone is broken down and weakened, called osteoporosis.

It had two arms (groups): Teriparatide (experimental) and Control (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

A single center, placebo-controlled, double blind parallel study of teriparatide use in patients requiring dental implant therapy is planned.

Both patients and investigators will be blinded.

Serum and gingival crevicular fluid (GCF) samples, radiographs, and a tetracycline-labelled bone core will constitute the main data gathered for analysis.

After implant surgery, patients will return at 2 weeks for post-operative care and then at 14 weeks for an implant impression and again at 16 weeks to receive the final restoration.

Who Took Part

27 actual participants took part.

It was open to people of any sex aged from 30 years up to 85 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age range 30-85 yrs. Sex: male and female (female subjects must be postmenopausal, surgically sterilized or utilizing birth control or abstinence throughout the period of Teriparatide administration). Subjects must be able and willing to follow study procedures and instructions;. Subjects must have read, understood and signed an informed consent form;. Subjects must have a need for the replacement of at least one tooth in the mandibular premolar/molar region with at least 12 months since the tooth extraction.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: subjects under 30 years or over 85 years of age,; female subjects who are pregnant, lactating, or female subjects who are of childbearing potential who are not using contraceptives,; subjects with prior radiation therapy, bone metastases or other skeletal malignancy,.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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

The Teriparatide group and the comparison group ran side by side rather than switching.

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

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

It started in 2011-02 with completion listed for 2015-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Bone Formation Rate (time frame: 10 weeks).

It also tracked 4 secondary outcomes, for example Bone Turnover (Mineral Apposition Rates), Bone Turnover: Cortical Tissue Area, Bone Turnover: Bone Perimeter Length and Bone Turnover: Bone Percentages.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 27 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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