The Forteo Alendronate Comparator Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 20 April 2015
• Main ID: NCT02416271
• Date of registration: 09/04/2015
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company
• Public title: The Forteo Alendronate Comparator Trial FACT
• Scientific title: Teriparatide Compared With Alendronate on Spine Bone Mineral Density in Postmenopausal Women With Osteoporosis
• Date of first enrolment: April 2001
• Target sample size: 203
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02416271
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Brazil, Mexico, Puerto Rico, United States

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion 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.



Age minimum: 45 Years
Age maximum: 85 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Osteoporosis

Intervention(s)

Dietary Supplement: Calcium

Dietary Supplement: Vitamin D

Drug: Alendronate

Drug: Placebo-SC

Drug: Placebo-Oral

Drug: Teriparatide

Primary Outcome(s)

Percent Change from Baseline to 18 Months in Lumbar Spine BMD [Time Frame: Baseline, 18 Months]

Secondary Outcome(s)

Percent Change from Baseline in Lumbar Spine BMD [Time Frame: Baseline, 3 Months, 6 Months, 12 Months]

Percent Change from Baseline in Trabecular BMD at the Femoral Neck [Time Frame: Baseline, 6 Months, 18 Months]

Percent Change from Baseline in Biochemical Marker -Bone-Specific Alkaline Phosphatase (BSAP) [Time Frame: 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]

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]

Percent Change from Baseline in Trabecular Volumetric BMD at the Lumbar Spine [Time Frame: Baseline, 6 Months, 18 Months]

Percent Change from Baseline in Cortical BMD at the Femoral Neck [Time Frame: Baseline, 6 Months, 18 Months]

Change from Baseline on the Back Pain Questionnaire [Time Frame: Baseline, 3 Months, 6 Months, 18 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]

Percentage of Participants with Clinical Fractures [Time Frame: 18 Months]

Percentage of Participants with Nonvertebral Fractures [Time Frame: 18 Months]

Percent Change from Baseline in Total Hip and Femoral Neck BMD [Time Frame: Baseline, 12 Months, 18 Months]

Secondary ID(s)

4943

B3D-MC-GHBM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors