Study of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00532207
First received: September 18, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

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


Condition Intervention Phase
Osteoporosis, Post-Menopausal
Drug: teriparatide
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Teriparatide 20 Micrograms in the Treatment of Postmenopausal Women With Osteoporosis

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 50
Study Start Date: November 2003
Study Completion Date: December 2004
Arms Assigned Interventions
Experimental: A Drug: teriparatide
subcutaneous 20 micrograms
Other Name: LY333334

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532207

Locations
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.
Moscow, Russian Federation
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00532207     History of Changes
Other Study ID Numbers: 8736, B3D-MW-GHCR
Study First Received: September 18, 2007
Last Updated: September 18, 2007
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014