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Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use

NCT00221299 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-06-25

Study results available
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Summary

The purpose of the study is to learn if one year of treatment with parathyroid hormone (PTH), either alone or with risedronate, will increase the thickness of the bones in the hip and spine in subjects with osteoporosis from chronic low dose steroid use. During the second year, the study will also look at whether taking risedronate will preserve the bone thickness created by one year of rhPTH 1-34 treatment.

Conditions

Interventions

DRUG

Risedronate

One 35mg tab of risedronate/placebo taken once a week for one year.

DRUG

Parathyroid Hormone

This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year.

Sponsors & Collaborators

Principal Investigators

  • Nancy E Lane, MD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2009-03-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00221299 on ClinicalTrials.gov