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Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

NCT00670501 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1637

Last updated 2008-05-01

No results posted yet for this study

Summary

The primary objective of this study is to demonstrate a reduction in the proportion of new vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and vitamin D alone.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

DRUG

teriparatide

40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase

DRUG

teriparatide

20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase

DRUG

Placebo

Placebo for subcutaneous injection will be supplied in a prefilled injection device with a cartridge identical in appearance to the LY333334 device.

DRUG

Calcium Supplement

Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement

DRUG

Vitamin D Supplement

Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-08-31
Primary Completion
1999-04-30
Completion
1999-04-30

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Finland
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
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 NCT00670501 on ClinicalTrials.gov