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Study of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

NCT ID: NCT00532207

Last Updated: 2007-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2004-12-31

Brief Summary

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To see if using teriparatide for 12 months will increase Bone Mineral Density at the lumbar spine in postmenopausal women with osteoporosis

Detailed Description

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Conditions

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Osteoporosis, Post-Menopausal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

teriparatide

Intervention Type DRUG

subcutaneous 20 micrograms

Interventions

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teriparatide

subcutaneous 20 micrograms

Intervention Type DRUG

Other Intervention Names

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LY333334

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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.

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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B3D-MW-GHCR

Identifier Type: -

Identifier Source: secondary_id

8736

Identifier Type: -

Identifier Source: org_study_id