Effects of Teriparatide on Distal Radius Fracture Healing

Colles' Fracture Clinical Trial

Official title:

Effects of Teriparatide on Distal Radius Fracture Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190944
• Other study ID #: 8175
• Secondary ID: B3D-MC-GHCN
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: October 10, 2007
• Start date: December 2004
• Est. completion date: June 2007

Study information

• Verified date: October 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Effects of Teriparatide on Distal Radius Fracture Healing

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colles' Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Drug:
• Teriparatide

• placebo

Locations

Country	Name	City	State
Mexico	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.	Monterrey
Poland	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.	Lublin
Poland	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.	Warsaw
Romania	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.	Bucharest
Romania	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.	Timisoara
Sweden	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.	Linkoping
United States	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.	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Mexico,  Poland,  Romania,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to radiographic healing
Secondary	There are no secondary outcomes for this trial

External Links

•   Lilly Clinical Trial Registry