Osteoporosis
Conditions
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.
Interventions
DRUGTeriparatide
Administered SC
DRUGAlendronate
Administered orally
DIETARY_SUPPLEMENTCalcium
Administered orally
DIETARY_SUPPLEMENTVitamin D
Administered orally
DRUGPlacebo-Oral
Administered orally
DRUGPlacebo-SC
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline to 18 Months in Lumbar Spine BMD | Baseline, 18 Months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Brazil, Mexico, Puerto Rico, United States
Outcome results
None listed