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Effects of Teriparatide on Distal Radius Fracture Healing

Primary Purpose

Colles' Fracture

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Teriparatide
placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colles' Fracture

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Ambulatory, postmenopausal, women 45 to 85 years of age. Postmenopausal is defined as at least 2 years without regular menses Sustained a unilateral, dorsally angulated fracture of the distal radius within 10 days Received conservative treatment of her distal radius fracture, including closed reduction and immobilization device (such as cast, splint, or brace) Free of severe or chronically disabling conditions other than a distal radius fracture as determined by the investigator Without language barrier, cooperative, expected to return for all follow-up procedures, and has given informed consent before entering the study and after being informed of the risks, medications and procedures to be used in the study. In the opinion of the investigator, the patient is willing to be trained and use the pen-injector daily, is able to satisfactorily use a pen-type injection delivery system, or is willing to receive daily subcutaneous injections from a care partner who has been trained to use the pen injector Exclusion Criteria: Increased baseline risk of osteosarcoma History of a malignant neoplasm in the 5 years prior to visit 2, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated Have currently known, suspected, or history of other diseases that affect bone metabolism other than postmenopausal osteoporosis or cause secondary osteoporosis that has been clinically active in the 1 year prior to visit 2 Have elevated serum calcium values Active liver disease or clinical jaundice History of symptomatic nephro-or urolithiasis in the 2 years prior to visit 2 Previous fractures or bone surgery in the currently fractured distal forearm Joint disease such as rheumatoid arthritis or disabling osteoarthritis that clearly affect the function of the wrist and/or hand of the injured arm Requirement for chronic treatment with nonsteroidal anti-inflammatory drugs defined as more than 3 consecutive months of any NSAID treatment Treatment with: Oral bisphosphonates for more than 18 months during the prior 3 years, or have received any oral or intravenous biphosphonate therapy within the last 2 months prior to screening. Oral strontium ranelate for any duration Systemic corticosteroids for more than 30 days (total) in the 6 months prior to visit 2, or any systemic corticosteroid dose in the 1 month prior to visit 2. Ophthalmic, oric, topical, or nasally inhaled corticosteroid therapy may be used without these restrictions. Fluoride at therapeutic doses (greater than or equal to 20mg/day) for more than 3 months during the last 2 years or for more than a total of 2 years, or any dosages within the 6 months prior to visit 2.

Sites / Locations

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Outcomes

Primary Outcome Measures

Time to radiographic healing

Secondary Outcome Measures

There are no secondary outcomes for this trial

Full Information

First Posted
September 12, 2005
Last Updated
October 10, 2007
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00190944
Brief Title
Effects of Teriparatide on Distal Radius Fracture Healing
Official Title
Effects of Teriparatide on Distal Radius Fracture Healing
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
Effects of Teriparatide on Distal Radius Fracture Healing

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colles' Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
105 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Teriparatide
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Time to radiographic healing
Secondary Outcome Measure Information:
Title
There are no secondary outcomes for this trial

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ambulatory, postmenopausal, women 45 to 85 years of age. Postmenopausal is defined as at least 2 years without regular menses Sustained a unilateral, dorsally angulated fracture of the distal radius within 10 days Received conservative treatment of her distal radius fracture, including closed reduction and immobilization device (such as cast, splint, or brace) Free of severe or chronically disabling conditions other than a distal radius fracture as determined by the investigator Without language barrier, cooperative, expected to return for all follow-up procedures, and has given informed consent before entering the study and after being informed of the risks, medications and procedures to be used in the study. In the opinion of the investigator, the patient is willing to be trained and use the pen-injector daily, is able to satisfactorily use a pen-type injection delivery system, or is willing to receive daily subcutaneous injections from a care partner who has been trained to use the pen injector Exclusion Criteria: Increased baseline risk of osteosarcoma History of a malignant neoplasm in the 5 years prior to visit 2, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated Have currently known, suspected, or history of other diseases that affect bone metabolism other than postmenopausal osteoporosis or cause secondary osteoporosis that has been clinically active in the 1 year prior to visit 2 Have elevated serum calcium values Active liver disease or clinical jaundice History of symptomatic nephro-or urolithiasis in the 2 years prior to visit 2 Previous fractures or bone surgery in the currently fractured distal forearm Joint disease such as rheumatoid arthritis or disabling osteoarthritis that clearly affect the function of the wrist and/or hand of the injured arm Requirement for chronic treatment with nonsteroidal anti-inflammatory drugs defined as more than 3 consecutive months of any NSAID treatment Treatment with: Oral bisphosphonates for more than 18 months during the prior 3 years, or have received any oral or intravenous biphosphonate therapy within the last 2 months prior to screening. Oral strontium ranelate for any duration Systemic corticosteroids for more than 30 days (total) in the 6 months prior to visit 2, or any systemic corticosteroid dose in the 1 month prior to visit 2. Ophthalmic, oric, topical, or nasally inhaled corticosteroid therapy may be used without these restrictions. Fluoride at therapeutic doses (greater than or equal to 20mg/day) for more than 3 months during the last 2 years or for more than a total of 2 years, or any dosages within the 6 months prior to visit 2.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
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.
City
Monterrey
ZIP/Postal Code
64461
Country
Mexico
Facility Name
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.
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
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.
City
Warsaw
ZIP/Postal Code
PL-02-0500
Country
Poland
Facility Name
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.
City
Bucharest
ZIP/Postal Code
0500988
Country
Romania
Facility Name
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.
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
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.
City
Linkoping
ZIP/Postal Code
58185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
19594305
Citation
Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia-Hernandez PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010 Feb;25(2):404-14. doi: 10.1359/jbmr.090731.
Results Reference
derived

Learn more about this trial

Effects of Teriparatide on Distal Radius Fracture Healing

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