This is a single-blinded, one-treatment, combination dose escalation and pharmacokinetic
study done in healthy volunteers. The investigators want to determine whether Parathyroid
Hormone related Protein (1-36) [PTHrP(1-36)] shares anabolic properties with the only
currently approved anabolic agent, parathyroid hormone(1-34) [PTH(1-34)], which stimulates
both osteoblastic bone resorption and formation. In a previous study done by the
investigators, postmenopausal osteoporotic women on estrogen received 6.56 mcg/kg PTHrP(1-36)
subcutaneously for three months daily. They experiences a 4.7% increase in bone mineral
density (BMD) of the lumbar spine when compared with those taking placebo. They also
displayed an increase in serum osteocalcin, a marker of bone formation, with no change in
several markers of bone resorption. It is believed that the rapid absorption and clearance of
PTHrP(1-36) likely plays a central role in its anabolic effect In order to further assess
absorption, we are combining both pharmacokinetic and dose escalation methods for studying
intravenous PTHrP given via a one-time bolus injection. The purpose is to define the maximum
safe dose and measure the pharmacokinetic parameters of a single intravenous dose of
Parathyroid Hormone-related Protein (1-36)[PTHrP(1-36)]. The results will be useful in
determining future treatment options for osteoporosis.
Phase:
Phase 1
Details
Lead Sponsor:
University of Pittsburgh
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Treatments:
Hormones Parathyroid Hormone Parathyroid Hormone-Related Protein