Effects of Teriparatide on Distal Radius Fracture Healing
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colles' Fracture
Intervention: Teriparatide (Drug); placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): 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, Study Director, Affiliation: Eli Lilly and Company
Summary
Effects of Teriparatide on Distal Radius Fracture Healing
Clinical Details
Official title: Effects of Teriparatide on Distal Radius Fracture Healing
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Time to radiographic healing
Secondary outcome: There are no secondary outcomes for this trial
Eligibility
Minimum age: 45 Years.
Maximum age: 85 Years.
Gender(s): Female.
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.
Locations and Contacts
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 64461, 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., Lublin 20-954, 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 PL-02-0500, 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., Bucharest 0500988, 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 300736, 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., Linkoping 58185, 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., New York, New York 10032, United States
Additional Information
Lilly Clinical Trial Registry
Starting date: December 2004
Last updated: October 10, 2007
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