Study of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis, Post-Menopausal
Intervention: teriparatide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): 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), Study Director, Affiliation: Eli Lilly and Company
Summary
To see if using teriparatide for 12 months will increase Bone Mineral Density at the
lumbar spine in postmenopausal women with osteoporosis
Clinical Details
Official title: Efficacy and Safety of Teriparatide 20 Micrograms in the Treatment of Postmenopausal Women With Osteoporosis
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To test the hypothesis that therapy for 12 months with once daily subcutaneous PTH 1-34 (teriparatide; TPTD) 20 micrograms will increase Bone Mineral Density (BMD) at the lumbar spine in postmenopausal women with osteoporosis
Secondary outcome: To test the hypothesis that therapy for 3 months with once daily subcutaneous teriparatide 20 micrograms will increase markers of bone formation (P1NP, BSAP) and bone resorption (serum CTX) in postmenopausal women with osteoporosisTo test the hypothesis that therapy for 12 months with once daily subcutaneous teriparatide 20 micrograms will increase markers of bone formation (P1NP, BSAP) and bone resorption (serum CTX) in postmenopausal women with osteoporosis. To evaluate safety of once daily subcutaneous teriparatide 20 micrograms for 12 months. To evaluate effect of teriparatide on changing in femoral neck and total hip BMD To test the hypothesis that treatment with TPTD will favorably affect back pain within the natural course of the disease To test the hypothesis that treatment with TPTD will favorably affect quality of life within the natural course of the disease
Eligibility
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Are postmenopausal women at least 55 years old and at least 2 years postmenopausal at
the time of entry into the trial, and who have given informed consent before entering
the study and after being informed of the risks, medications, and procedures to be
used in the study. In addition, women below the age of 60 years with indeterminate
menopause due to premenopausal hysterectomy must have their postmenopausal status
confirmed with a serum FSH level > 30 IU/L.
- Posterior-anterior lumbar spine (L1-L4) BMD and/or femoral neck BMD measurement at
least < 2. 5 standard deviation (SD) from the mean of healthy, pre-menopausal women.
- Results of lumbar BMD (L1-L4) measurement must be available. The initial lumbar spine
assessment and the determination of the patient's eligibility for entry into the
screening phase will be made by the individual investigator. If the L-1 vertebra
cannot be analyzed due to artifact, vertebral fracture, osteophytes, or other
abnormalities, that vertebra should be excluded from the analysis.
- Normal or clinically insignificant abnormal laboratory values (as defined by the
investigator) including serum calcium, 25 hydroxyvitamin D levels and alkaline
phosphatase.
- Willing to be trained on and use a pen type injection delivery system on a daily
basis for 12 months.
Exclusion Criteria:
- Active liver disease - liver enzymes (ALT, AST) more than three times the upper
normal range, or a bilirubin of > 2. 0 mg/dl, or clinical jaundice.
- Abnormal thyroid function not corrected by therapy. Normal thyroid function will be
documented by a normal TSH during screening phase
- History of active nephrolithiasis or urolithiasis in the prior 2 years. Patients with
any documented history of nephro- or urolithiasis must have had an appropriate
imaging procedure within the prior 6 months, such as, an intravenous pyelography
(IVP), supine radiograph of the kidney ureter bladder (KUB), or renal ultrasound,
which must document the absence of stones
- History of malignant neoplasms within the prior 5 years, with the exception of
superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been
definitively treated. If malignant neoplasm was ever diagnosed, patient must
presently be free of disease.
- Current pharmacological treatment for osteoporosis, other than calcium and Vitamin D
- History of Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes
of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption
Locations and Contacts
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., Moscow, Russian Federation
Additional Information
Lilly Clinical Trial Registry
Starting date: November 2003
Last updated: September 18, 2007
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