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Teriparatide Use in Hip Replaced Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00191321
First Posted: September 19, 2005
Last Update Posted: January 26, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  Purpose

A pilot study on the use of Teriparatide in severe osteoporotic women with hip fracture and submitted to hip replacement

The primary objective of this study is to obtain preliminary data, in a pilot group of postmenopausal women with established osteoporosis and a recent hip fracture, who underwent hip replacement 3-6 months before screening phase, about the effect of teriparatide on:

  • bone turnover markers: CTx, PINP and BSAP when given at the dose of 20 mcg/day by subcutaneous route for 18 months.

The secondary objectives of the study are as follows:

  • Effects of teriparatide on lumbar spine and non-prosthetic femur bone density, as assessed by BMD measurement with dual energy x-ray absorptiometry (DXA)
  • Effects of teriparatide on quality of life and back pain during treatment.

Condition Intervention Phase
Osteoporosis Drug: Teriparatide Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TUHRS Study - Teriparatide Use in Hip Replaced Subjects A Pilot Study on the Use of Teriparatide in Severe Osteoporotic Women With Hip Fracture and Submitted to Hip Replacement

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Effect of Teriparatide (20 mcg/day for 18 months ) on bone turnover markers: CTx, PINP and BSAP

Secondary Outcome Measures:
  • Effects of teriparatide on lumbar spine and non-prosthetic femur bone density, as assessed by BMD measurement with dual energy x-ray absorptiometry (DXA)
  • Effects of teriparatide on quality of life and back pain during treatment.

Estimated Enrollment: 60
Study Start Date: July 2004
Estimated Study Completion Date: December 2005
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ambulatory postmenopausal women with established osteoporosis, based on the disease diagnostic criteria
  2. Presence of more than 1 clinical and/or radiological vertebral fractures OR more than 1 non-vertebral fracture
  3. Presence of hip fracture with hip replacement surgical procedure (both uncemented or cemented total hip arthroplastics or endoprosthesis) in the 3-6 months before screening phase
  4. Age range 55-85 years
  5. Normal or clinically insignificant abnormal laboratory values (as determined by the investigator) including serum calcium, PTH(1 84), and 25 hydroxyvitamin D concentrations, and alkaline phosphatase activity.

Exclusion Criteria:

  1. History of diseases which affect bone metabolism, other than primary postmenopausal osteoporosis, such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis (included glucocorticoid-induced osteoporosis), hypoparathyroidism, hyperparathyroidism, hyperthyroidism
  2. Actual cancer disease or history of malignant neoplasms in the 5 years prior to Visit 2, with the exception of superficial basal cell or squamous cell carcinomas of the skin that have been definitively treated. Subjects with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may be enrolled.
  3. Increased baseline risk of osteosarcoma: Paget's disease of the bone or unexplained elevations of alkaline phosphatase; Prior radiation therapy involving the skeleton
  4. Significantly impaired renal function
  5. Significantly impaired hepatic function
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00191321


Locations
Italy
For additional information regarding investigative sites for thsi 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.
Alghero, Italy
For additional information regarding investigative sites for thsi 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.
Bergamo, Italy
For additional information regarding investigative sites for thsi 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.
Firenze, Italy
For additional information regarding investigative sites for thsi 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.
Genova, Italy
For additional information regarding investigative sites for thsi 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.
Milano, Italy
For additional information regarding investigative sites for thsi 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.
Monza, Italy
For additional information regarding investigative sites for thsi 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.
Palermo, Italy
For additional information regarding investigative sites for thsi 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.
Pietra Ligure, Italy
For additional information regarding investigative sites for thsi 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.
Siena, Italy
For additional information regarding investigative sites for thsi 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.
Treviglio, Italy
For additional information regarding investigative sites for thsi 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.
Udine, Italy
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

ClinicalTrials.gov Identifier: NCT00191321     History of Changes
Other Study ID Numbers: 9151
B3D-IT-GHCU
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: January 26, 2007
Last Verified: January 2007

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