NCT00191321

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

January 26, 2007

Status Verified

January 1, 2007

First QC Date

September 12, 2005

Last Update Submit

January 24, 2007

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • 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.

Interventions

TeriparatideDRUG

Eligibility Criteria

Age55 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ambulatory postmenopausal women with established osteoporosis, based on the disease diagnostic criteria
  • Presence of more than 1 clinical and/or radiological vertebral fractures OR more than 1 non-vertebral fracture
  • 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
  • Age range 55-85 years
  • 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.

You may not qualify if:

  • 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
  • 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.
  • Increased baseline risk of osteosarcoma: Paget's disease of the bone or unexplained elevations of alkaline phosphatase; Prior radiation therapy involving the skeleton
  • Significantly impaired renal function
  • Significantly impaired hepatic function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

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

Location

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

Location

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.

Florence, Italy

Location

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

Location

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.

Milan, Italy

Location

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

Location

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

Location

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

Location

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

Location

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

Location

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

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

July 1, 2004

Study Completion

December 1, 2005

Last Updated

January 26, 2007

Record last verified: 2007-01

Locations

IT(11)