At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 61 enrolled

Drug / intervention

Parathyroid Hormone-related Protein +1 moredrug

Likely dose

Parathyroid Hormone-related Protein 500 microgramsfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00222872

NCT00222872Phase 1Completed

Compare CT.gov

A Three Week Dose Escalation Study of PTHrP(1-36) in Postmenopausal Women

University of Pittsburgh·interventional·Posted Sep 22, 2005·Updated Apr 28, 2014

In Brief

A Phase 1 clinical trial evaluating Parathyroid Hormone-related Protein and Placebo for Osteoporosis and Osteoporosis, Postmenopausal. Completed, enrolled 61 participants across 1 site.

Detailed Summary

The main purpose of this study is to determine the safety and effectiveness of three week daily subcutaneous injections of Parathyroid Hormone-related Protein (1-36). Previous studies indicated that PTHrP has a skeletal 'anabolic' or bone-building effect, and has shown to increase bone mineral density in postmenopausal women with osteoporosis. Safety of PTHrP will be determined by measurements of blood pressure and pulse, serum blood calcium levels and subjective symptoms. Effectiveness will be measured by changes in measurements of blood and urine markers of bone turnover.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsOsteoporosis, Osteoporosis, Postmenopausal

CountriesUnited States

CollaboratorsNational Institutes of Health (NIH), Department of Health and Human Services

Timeline

Phase 1CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2005

First PostedSep 2005

Primary CompletionSep 2008

TodayJul 2026

First PostedSep 22, 2005

Enrollment StartJul 1, 2005

Primary CompletionSep 1, 2008

TodayJul 2, 2026

Enrollment to primary: 3.2 yearsPosted 20.8 years ago

Interventions

Parathyroid Hormone-related Proteindrug

PTHrP(1-36) starting at 500 micrograms, then increasing by 125 micrograms up to a maximum of 1,500 micrograms.

Placebodrug

Placebo drug via subcutaneous injection in single blinded fashion daily for 3 weeks