Trials Sponsors Conditions Drugs Pricing

Conditions

Femur Neck Fracture

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture
Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.
12 months

Secondary Outcomes (13)

Percentage of Participants With Radiographic Evidence of Healing
Randomization up to 12 months
Percentage of Participants With Pain Control During Ambulation
Up to 12 months
Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit
Up to 12 months
Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing
Up to 12 months
Percentage of Participants With Functional Evidence of Healing
Up to 12 Months
+8 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Administered once daily by subcutaneous (SC) injection for 6 months

Drug: PlaceboDietary Supplement: Calcium supplementationDietary Supplement: Vitamin D supplementation

Teriparatide

EXPERIMENTAL

20 microgram (µg) administered once daily by SC injection for 6 months

Drug: TeriparatideDietary Supplement: Calcium supplementationDietary Supplement: Vitamin D supplementation

Interventions

TeriparatideDrug

Administered by SC injection

Also known as: Forteo, Forsteo, LY333334

Teriparatide

PlaceboDrug

Administered by SC injection

Placebo

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Community dwelling men and postmenopausal women who were ambulatory before sustaining a low-trauma, unilateral femoral neck fracture (displaced or nondisplaced)
Other than femoral neck fracture, be free of incapacitating conditions and have a life expectancy of at least 2 years

Sponsors & Collaborators

Eli Lilly and Company
Industrylead

Study Sites (75)

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.

San Diego, California, 92103, United States

Golden, Colorado, 80401, United States

Washington D.C., District of Columbia, 20037, United States

Gainesville, Georgia, 30501, United States

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptides

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Enrollment

39 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 14, 2011

First Posted

November 17, 2011

Study Start

January 2012

Date type not reported

This date has not been verified as actual or estimated.

Second Study of the Effect of Teriparatide on Hip Fracture Healing

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (2)

Placebo

Teriparatide

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (75)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (2)

Placebo

Teriparatide

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (75)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations