Study of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

September 18, 2007 updated by: Eli Lilly and Company

Efficacy and Safety of Teriparatide 20 Micrograms in the Treatment of Postmenopausal Women With Osteoporosis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: teriparatide
subcutaneous 20 micrograms
Other Names:
  • LY333334

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Measures

Outcome Measure
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 osteoporosis
To 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

September 18, 2007

First Submitted That Met QC Criteria

September 18, 2007

First Posted (Estimate)

September 20, 2007

Study Record Updates

Last Update Posted (Estimate)

September 20, 2007

Last Update Submitted That Met QC Criteria

September 18, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8736
  • B3D-MW-GHCR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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