The Forteo Alendronate Comparator Trial (FACT)

April 9, 2015 updated by: Eli Lilly and Company

Teriparatide Compared With Alendronate on Spine Bone Mineral Density in Postmenopausal Women With Osteoporosis

The main purpose of this study is to evaluate the effects of teriparatide with those of alendronate on spine bone mineral density (BMD) and other osteoporosis factors in postmenopausal women with osteoporosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Recife, Brazil, 52051
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sao Paulo, Brazil, 040024
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Mexico
      • Mexico City, Mexico, 14000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mezzanine, Mexico, 06100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36693
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • California
      • Tustin, California, United States, 92780
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Colorado
      • Lakewood, Colorado, United States, 80227
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Illinois
      • Chicago, Illinois, United States, 60611
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Springfield, Illinois, United States, 62704
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Massachusetts
      • West Boylston, Massachusetts, United States, 01583
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Minnesota
      • Arden Hills, Minnesota, United States, 55126
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Missouri
      • St Louis, Missouri, United States, 63110
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Oregon
      • Portland, Oregon, United States, 97213
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Pennsylvania
      • Pittsburg, Pennsylvania, United States, 15213
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal women with osteoporosis.
  • Ambulatory, 5 years or more past menopause.
  • BMD T score between -2.5 and -4.0 at the lumbar spine or femoral neck.
  • Normal or clinically insignificant abnormal laboratory values, including serum calcium, parathyroid hormone (PTH) 1-84, 25-hydroxyvitamin D, and alkaline phosphatase.

Exclusion Criteria:

  • Prior treatment with PTH or a PTH analogue.
  • Treatment with bisphosphonates within 12 months, anabolic corticosteroids or calcitriol or vitamin D analogues or agonists within 6 months, estrogens or selective estrogen receptor modulators within 3 months, or calcitonin within 2 months; therapeutic doses of fluoride; systemic corticosteroid use within 1 month or for more than 30 days in the prior year; use of anticoagulants within 1 month.
  • History of diseases other than postmenopausal osteoporosis that affect bone metabolism.
  • History of an increased risk of osteosarcoma (ie, patients with Paget disease of bone, previous skeletal exposure to external beam radiotherapy, or previous malignant neoplasm involving the skeleton).
  • Malignant neoplasms within 5 years; carcinoma in situ of the uterine cervix within 1 year.
  • Nephrolithiasis or urolithiasis within 2 years, or impaired renal function.
  • Abnormal uncorrected thyroid function.
  • Liver disease or clinical jaundice.
  • Alcohol or other drug abuse.
  • Poor medical or psychiatric risk for treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Teriparatide
20 micrograms per day teriparatide subcutaneous (SC) injection plus oral placebo for 18 months.
Drug: Teriparatide
Administered SC
Other Names:
  • Forteo
  • LY333334
  • Forsteo
Dietary supplement: Calcium
Administered orally
Dietary supplement: Vitamin D
Administered orally
Drug: Placebo-Oral
Administered orally
Active Comparator: Alendronate
10 milligrams/day alendronate orally plus SC injection placebo for 18 months.
Dietary supplement: Calcium
Administered orally
Dietary supplement: Vitamin D
Administered orally
Drug: Alendronate
Administered orally
Drug: Placebo-SC
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline to 18 Months in Lumbar Spine BMD
Time Frame: Baseline, 18 Months
Baseline, 18 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Lumbar Spine BMD
Time Frame: Baseline, 3 Months, 6 Months, 12 Months
Baseline, 3 Months, 6 Months, 12 Months
Percent Change from Baseline in Total Hip and Femoral Neck BMD
Time Frame: Baseline, 12 Months, 18 Months
Baseline, 12 Months, 18 Months
Percent Change from Baseline in Trabecular Volumetric BMD at the Lumbar Spine
Time Frame: Baseline, 6 Months, 18 Months
Baseline, 6 Months, 18 Months
Percent Change from Baseline in Cortical BMD at the Femoral Neck
Time Frame: Baseline, 6 Months, 18 Months
Baseline, 6 Months, 18 Months
Percent Change from Baseline in Trabecular BMD at the Femoral Neck
Time Frame: Baseline, 6 Months, 18 Months
Baseline, 6 Months, 18 Months
Percent Change from Baseline in Biochemical Marker -Serum Procollagen I C-Terminal Propeptide (PICP)
Time Frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percent Change from Baseline in Biochemical Marker -Serum Procollagen I N-Terminal Propeptide (PINP)
Time Frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percent Change from Baseline in Biochemical Marker -Bone-Specific Alkaline Phosphatase (BSAP)
Time Frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percent Change from Baseline in Biochemical Marker -Urinary N-Telopeptide (NTX)
Time Frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percentage of Participants with Nonvertebral Fractures
Time Frame: 18 Months
18 Months
Percentage of Participants with Clinical Fractures
Time Frame: 18 Months
18 Months
Change from Baseline on the Back Pain Questionnaire
Time Frame: Baseline, 3 Months, 6 Months, 18 Months
Baseline, 3 Months, 6 Months, 18 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

May 1, 2003

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

April 9, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4943
  • B3D-MC-GHBM (Other Identifier: Eli Lilly and Company)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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