NCT01279187

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

Terminated Phase 2 Results posted Last updated 31 January 2018

What this trial tests

Phase 2 trial testing Teriparatide in Implant in 27 participants. Terminated before completion.

Timeline

1 February 2011

Primary endpoint
1 March 2015

1 November 2015

Quick facts

Lead sponsor	University of Michigan
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	27
Start date	1 February 2011
Primary completion	1 March 2015
Estimated completion	1 November 2015
Sites	1 location across United States

Drugs / interventions tested

• Teriparatide — full drug profile →
• Placebo

Conditions studied

• Implant — all drugs for Implant →

Sponsor

University of Michigan

Who can join

Adults 30 to 85, any sex, with Implant. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Bone Formation Rate
  Time frame: 10 weeks
  To determine the impact of PTH on bone quality and bone turnover in the oral cavity. The primary outcome variable will be bone formation rate.

Sponsor's own description

Good bone healing and bone build-up are necessary for the success of dental implants. Research in animals and humans has shown that a drug, called Forteo, can increase bone build-up and bone strength over time. 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. The investigators do not know, however, whether Forteo is effective for use in humans for improving bone healing after implant placement, and whether it will have the same bone-building and bone-strengthening effects as for patients with osteoporosis. This research study is being done to learn what effect 7 weeks of treatment with Forteo will have on bone build-up and strengthening of bone for patients receiving implants.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Bioactive peptides and proteins for tissue repair: microenvironment modulation, rational delivery, and clinical potential.
   Hao ZW, Zhang ZY, Wang ZP, Wang Y, et al · · 2024 · cited 24× · PMID 39639374 · DOI 10.1186/s40779-024-00576-x