FACT: The Forteo Alendronate Comparator Trial
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| 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:
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
|
Outcome Measures
Primary Outcome Measures
- Percent Change from Baseline to 18 Months in Lumbar Spine BMD [Baseline, 18 Months]
Secondary Outcome Measures
- Percent Change from Baseline in Lumbar Spine BMD [Baseline, 3 Months, 6 Months, 12 Months]
- Percent Change from Baseline in Total Hip and Femoral Neck BMD [Baseline, 12 Months, 18 Months]
- Percent Change from Baseline in Trabecular Volumetric BMD at the Lumbar Spine [Baseline, 6 Months, 18 Months]
- Percent Change from Baseline in Cortical BMD at the Femoral Neck [Baseline, 6 Months, 18 Months]
- Percent Change from Baseline in Trabecular BMD at the Femoral Neck [Baseline, 6 Months, 18 Months]
- Percent Change from Baseline in Biochemical Marker -Serum Procollagen I C-Terminal Propeptide (PICP) [Baseline, 1 Month, 3 Months, 6 Months, 12 Months]
- Percent Change from Baseline in Biochemical Marker -Serum Procollagen I N-Terminal Propeptide (PINP) [Baseline, 1 Month, 3 Months, 6 Months, 12 Months]
- Percent Change from Baseline in Biochemical Marker -Bone-Specific Alkaline Phosphatase (BSAP) [Baseline, 1 Month, 3 Months, 6 Months, 12 Months]
- Percent Change from Baseline in Biochemical Marker -Urinary N-Telopeptide (NTX) [Baseline, 1 Month, 3 Months, 6 Months, 12 Months]
- Percentage of Participants with Nonvertebral Fractures [18 Months]
- Percentage of Participants with Clinical Fractures [18 Months]
- Change from Baseline on the Back Pain Questionnaire [Baseline, 3 Months, 6 Months, 18 Months]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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 |
| 2 | 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 |
| 3 | 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 |
| 4 | 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 |
| 5 | 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 |
| 6 | 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 |
| 7 | 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 |
| 8 | 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 |
| 9 | 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 |
| 10 | 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 |
| 11 | 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 |
| 12 | 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 |
| 13 | 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 |
| 14 | 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 |
| 15 | 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 |
| 16 | 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 | |
| 17 | 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 | |
| 18 | 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 | |
| 19 | 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 | |
| 20 | 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
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4943
- B3D-MC-GHBM