A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture

NCT00887354 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2019-09-25

Study results available
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Summary

This study will evaluate whether teriparatide is superior to the active comparator in the change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal women with low bone mass and a recent pertrochanteric hip fracture.

Conditions

Interventions

DRUG

Teriparatide

Administered subcutaneously

DRUG

Risedronate

Administered orally

DRUG

Placebo

Weekly: Administered orally Daily: Administered subcutaneously

DIETARY_SUPPLEMENT

Calcium

Approximately 500 to 1000 mg/day administered orally throughout study.

DIETARY_SUPPLEMENT

Vitamin D

Approximately 800 International Units per day (IU/day) administered orally throughout study.

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM eastern time (UTC/GMT-5hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States
  • Canada
  • Croatia
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Italy
  • Mexico
  • Norway
  • Spain

Study Locations

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Entities

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 NCT00887354 on ClinicalTrials.gov