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The Forteo Alendronate Comparator Trial (FACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02416271
Recruitment Status : Completed
First Posted : April 14, 2015
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Teriparatide Drug: Alendronate Dietary Supplement: Calcium Dietary Supplement: Vitamin D Drug: Placebo-Oral Drug: Placebo-SC Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Teriparatide Compared With Alendronate on Spine Bone Mineral Density in Postmenopausal Women With Osteoporosis
Study Start Date : April 2001
Actual Primary Completion Date : May 2003
Actual Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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:
  • LY333334
  • Forteo
  • 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.
Drug: Alendronate
Administered orally

Dietary Supplement: Calcium
Administered orally

Dietary Supplement: Vitamin D
Administered orally

Drug: Placebo-SC
Administered SC




Primary Outcome Measures :
  1. Percent Change from Baseline to 18 Months in Lumbar Spine BMD [ Time Frame: Baseline, 18 Months ]

Secondary Outcome Measures :
  1. Percent Change from Baseline in Lumbar Spine BMD [ Time Frame: Baseline, 3 Months, 6 Months, 12 Months ]
  2. Percent Change from Baseline in Total Hip and Femoral Neck BMD [ Time Frame: Baseline, 12 Months, 18 Months ]
  3. Percent Change from Baseline in Trabecular Volumetric BMD at the Lumbar Spine [ Time Frame: Baseline, 6 Months, 18 Months ]
  4. Percent Change from Baseline in Cortical BMD at the Femoral Neck [ Time Frame: Baseline, 6 Months, 18 Months ]
  5. Percent Change from Baseline in Trabecular BMD at the Femoral Neck [ Time Frame: Baseline, 6 Months, 18 Months ]
  6. 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 ]
  7. 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 ]
  8. Percent Change from Baseline in Biochemical Marker -Bone-Specific Alkaline Phosphatase (BSAP) [ Time Frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months ]
  9. Percent Change from Baseline in Biochemical Marker -Urinary N-Telopeptide (NTX) [ Time Frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months ]
  10. Percentage of Participants with Nonvertebral Fractures [ Time Frame: 18 Months ]
  11. Percentage of Participants with Clinical Fractures [ Time Frame: 18 Months ]
  12. Change from Baseline on the Back Pain Questionnaire [ Time Frame: Baseline, 3 Months, 6 Months, 18 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416271


Locations
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United States, Alabama
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.
Mobile, Alabama, United States, 36693
United States, California
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.
Tustin, California, United States, 92780
United States, Colorado
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.
Lakewood, Colorado, United States, 80227
United States, Hawaii
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.
Honolulu, Hawaii, United States, 96814
United States, Illinois
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.
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
United States, Indiana
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.
Indianapolis, Indiana, United States, 46260
United States, Massachusetts
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.
West Boylston, Massachusetts, United States, 01583
United States, Minnesota
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.
Arden Hills, Minnesota, United States, 55126
United States, Missouri
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.
St Louis, Missouri, United States, 63110
United States, New Jersey
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.
Morristown, New Jersey, United States, 07960
United States, North Carolina
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.
Greenville, North Carolina, United States, 27834
United States, Oregon
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.
Portland, Oregon, United States, 97213
United States, Pennsylvania
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.
Pittsburg, Pennsylvania, United States, 15213
United States, Rhode Island
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.
Providence, Rhode Island, United States, 02903
Brazil
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.
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
Mexico
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 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
Puerto Rico
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.
San Juan, Puerto Rico, 00935
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02416271    
Other Study ID Numbers: 4943
B3D-MC-GHBM ( Other Identifier: Eli Lilly and Company )
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Alendronate
Teriparatide
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents