Parathyroid hormone-related protein for the treatment of postmenopausal osteoporosis: defining the maximal tolerable dose.

ABSTRACT:

Context

PTH is the only approved skeletal anabolic agent for the treatment of human osteoporosis. Unlike PTH, which is a mixed anabolic and catabolic agent, PTHrP displays features suggesting that it may be a pure anabolic agent when intermittently administered. The full dose range of PTHrP is unknown.

Objectives

The primary objective of the study was to define the complete therapeutic window and dose-limiting toxicities of PTHrP. The secondary objective was to determine whether PTHrP retains a pure anabolic profile at the highest usable doses.

Design

This was a single-blinded, two-part, dose-escalating clinical trial.

Setting

The study was conducted in a university academic setting.

Patients or other participants

Participants included 41 healthy postmen

SUBMITTER: Horwitz MJ 

PROVIDER: S-EPMC2841539 | biostudies-literature | 2010 Mar

REPOSITORIES: biostudies-literature