The Forteo Alendronate Comparator Trial
Phase 4
Completed
- Conditions
- Osteoporosis
- Interventions
- Dietary Supplement: CalciumDietary Supplement: Vitamin DDrug: Placebo-OralDrug: Placebo-SC
- Registration Number
- NCT02416271
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 203
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Teriparatide Vitamin D 20 micrograms per day teriparatide subcutaneous (SC) injection plus oral placebo for 18 months. Alendronate Vitamin D 10 milligrams/day alendronate orally plus SC injection placebo for 18 months. Teriparatide Calcium 20 micrograms per day teriparatide subcutaneous (SC) injection plus oral placebo for 18 months. Teriparatide Placebo-Oral 20 micrograms per day teriparatide subcutaneous (SC) injection plus oral placebo for 18 months. Alendronate Calcium 10 milligrams/day alendronate orally plus SC injection placebo for 18 months. Alendronate Placebo-SC 10 milligrams/day alendronate orally plus SC injection placebo for 18 months. Teriparatide Teriparatide 20 micrograms per day teriparatide subcutaneous (SC) injection plus oral placebo for 18 months. Alendronate Alendronate 10 milligrams/day alendronate orally plus SC injection placebo for 18 months.
- Primary Outcome Measures
Name Time Method Percent Change from Baseline to 18 Months in Lumbar Spine BMD Baseline, 18 Months
- Secondary Outcome Measures
Name Time Method Percent Change from Baseline in Lumbar Spine BMD Baseline, 3 Months, 6 Months, 12 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 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 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
Trial Locations
- Locations (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.
🇵🇷San Juan, Puerto Rico