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Comparison Study of PTHrP and PTH to Treat Osteoporosis

NCT00853723 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2016-03-24

Study results available
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Summary

This is a three month comparison trial of standard dose parathyroid hormone (PTH) (1-34) and two different doses of Parathyroid Hormone-related Protein (PTHrP) (1-36). The investigators want to to demonstrate that daily subcutaneous injection of PTHrP (1-36) in postmenopausal women with osteoporosis stimulates bone formation to the same or greater degree than PTH (1-34) but with less bone resorption.

Conditions

Interventions

DRUG

Parathyroid hormone related protein (1-36)

PTHrP (1-36) 400 micrograms / day administered subcutaneously for 3 months

DRUG

Parathyroid hormone related protein(1-36)

PTHrP(1-36)600 micrograms subcutaneously administered daily for 3 months

DRUG

Parathyroid hormone (1-34)

PTH(1-34)20 micrograms subcutaneously administered daily for 3 months

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Mara J Horwitz, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-02-29
Completion
2012-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00853723 on ClinicalTrials.gov