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The Forteo Alendronate Comparator Trial (FACT)

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Teriparatide

Alendronate

Calcium

Vitamin D

Placebo-Oral

Placebo-SC

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Teriparatide

Alendronate

Arm Description

20 micrograms per day teriparatide subcutaneous (SC) injection plus oral placebo for 18 months.

10 milligrams/day alendronate orally plus SC injection placebo for 18 months.

Outcomes

Primary Outcome Measures

Percent Change from Baseline to 18 Months in Lumbar Spine BMD

Secondary Outcome Measures

Percent Change from Baseline in Lumbar Spine BMD

Percent Change from Baseline in Total Hip and Femoral Neck BMD

Percent Change from Baseline in Trabecular Volumetric BMD at the Lumbar Spine

Percent Change from Baseline in Cortical BMD at the Femoral Neck

Percent Change from Baseline in Trabecular BMD at the Femoral Neck

Percent Change from Baseline in Biochemical Marker -Serum Procollagen I C-Terminal Propeptide (PICP)

Percent Change from Baseline in Biochemical Marker -Serum Procollagen I N-Terminal Propeptide (PINP)

Percent Change from Baseline in Biochemical Marker -Bone-Specific Alkaline Phosphatase (BSAP)

Percent Change from Baseline in Biochemical Marker -Urinary N-Telopeptide (NTX)

Percentage of Participants with Nonvertebral Fractures

Percentage of Participants with Clinical Fractures

Change from Baseline on the Back Pain Questionnaire

Full Information

NCT ID

NCT02416271

First Posted

April 9, 2015

Last Updated

April 9, 2015

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02416271

Brief Title

The Forteo Alendronate Comparator Trial

Acronym

FACT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

April 2001 (undefined)

Primary Completion Date

May 2003 (Actual)

Study Completion Date

May 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

203 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Teriparatide

Arm Type

Experimental

Arm Description

20 micrograms per day teriparatide subcutaneous (SC) injection plus oral placebo for 18 months.

Arm Title

Alendronate

Arm Type

Active Comparator

Arm Description

10 milligrams/day alendronate orally plus SC injection placebo for 18 months.

Intervention Type

Drug

Intervention Name(s)

Teriparatide

Other Intervention Name(s)

LY333334, Forteo, Forsteo

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Alendronate

Intervention Description

Administered orally

Intervention Type

Dietary Supplement

Intervention Name(s)

Calcium

Intervention Description

Administered orally

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Placebo-Oral

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Placebo-SC

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

Percent Change from Baseline to 18 Months in Lumbar Spine BMD

Time Frame

Baseline, 18 Months

Secondary Outcome Measure Information:

Title

Percent Change from Baseline in Lumbar Spine BMD

Time Frame

Baseline, 3 Months, 6 Months, 12 Months

Title

Percent Change from Baseline in Total Hip and Femoral Neck BMD

Time Frame

Baseline, 12 Months, 18 Months

Title

Percent Change from Baseline in Trabecular Volumetric BMD at the Lumbar Spine

Time Frame

Baseline, 6 Months, 18 Months

Title

Percent Change from Baseline in Cortical BMD at the Femoral Neck

Time Frame

Baseline, 6 Months, 18 Months

Title

Percent Change from Baseline in Trabecular BMD at the Femoral Neck

Time Frame

Baseline, 6 Months, 18 Months

Title

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

Title

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

Title

Percent Change from Baseline in Biochemical Marker -Bone-Specific Alkaline Phosphatase (BSAP)

Time Frame

Baseline, 1 Month, 3 Months, 6 Months, 12 Months

Title

Percent Change from Baseline in Biochemical Marker -Urinary N-Telopeptide (NTX)

Time Frame

Baseline, 1 Month, 3 Months, 6 Months, 12 Months

Title

Percentage of Participants with Nonvertebral Fractures

Time Frame

18 Months

Title

Percentage of Participants with Clinical Fractures

Time Frame

18 Months

Title

Change from Baseline on the Back Pain Questionnaire

Time Frame

Baseline, 3 Months, 6 Months, 18 Months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36693

Country

United States

Facility Name

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

City

Lakewood

State/Province

Colorado

ZIP/Postal Code

80227

Country

United States

Facility Name

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

City

West Boylston

State/Province

Massachusetts

ZIP/Postal Code

01583

Country

United States

Facility Name

City

Arden Hills

State/Province

Minnesota

ZIP/Postal Code

55126

Country

United States

Facility Name

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07960

Country

United States

Facility Name

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

City

Pittsburg

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

City

Recife

ZIP/Postal Code

52051

Country

Brazil

Facility Name

City

Sao Paulo

ZIP/Postal Code

040024

Country

Brazil

Facility Name

City

Mexico City

ZIP/Postal Code

14000

Country

Mexico

Facility Name

City

Mezzanine

ZIP/Postal Code

06100

Country

Mexico

Facility Name

City

San Juan

ZIP/Postal Code

00935

Country

Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

The Forteo Alendronate Comparator Trial

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