Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Teriparatide Use in Hip Replaced Subjects
This study has been completed.
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00191321
  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 III

MedlinePlus related topics: Back Pain Fractures Hip Injuries and Disorders Hip Replacement Osteoporosis
Drug Information available for: Teriparatide Teriparatide acetate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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

Ages Eligible for Study:   55 Years to 85 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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.
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.
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.
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.
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.
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.
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.
Udine, 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.
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.
Monza, 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

Study ID Numbers: 9151, B3D-IT-GHCU
Study First Received: September 12, 2005
Last Updated: January 24, 2007
ClinicalTrials.gov Identifier: NCT00191321  
Health Authority: Italy: Ministry of Health

Study placed in the following topic categories:
Hip Fractures
Musculoskeletal Diseases
Teriparatide
Fractures, Bone
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009