The Forteo Alendronate Comparator Trial

Eli Lilly and Company203 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

203

Conditions

Osteoporosis

Interventions

TeriparatideDRUG

Administered SC

AlendronateDRUG

Administered orally

CalciumDIETARY_SUPPLEMENT

Administered orally

Vitamin D

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (20)

Outcomes

Primary Outcomes

Percent Change from Baseline to 18 Months in Lumbar Spine BMD

Time frame: Baseline, 18 Months

Secondary Outcomes

Percent Change from Baseline in Lumbar Spine BMD

Time frame: 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

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

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 -Serum Procollagen I C-Terminal Propeptide (PICP)

Time frame: 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

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)

Data from ClinicalTrials.gov

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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

Tustin, California, United States

Lakewood, Colorado, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Springfield, Illinois, United States

Indianapolis, Indiana, United States

West Boylston, Massachusetts, United States

Arden Hills, Minnesota, United States

St Louis, Missouri, United States

...and 10 more locations