CClinicalTrials.gg
CompletedNCT00190944Updated Oct 12, 2007

Effects of Teriparatide on Distal Radius Fracture Healing

A Phase 2 interventional study of Teriparatide and placebo in Colles' Fracture, sponsored by Eli Lilly and Company. Completed at 7 sites in 5 countries. Open to female participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2007-10-12.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
45 Years to 85 Years
Sex
Female
01

Study summary

Effects of Teriparatide on Distal Radius Fracture Healing

02

Conditions studied

03

In context

Colles' Fracture

30 studies on the registry are indexed under Colles' Fracture; 4 are open to participants now.

This study's enrollment of 105 is above the median of 80 across 27 interventional studies indexed under Colles' Fracture.

Browse Colles' Fracture studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
105 participants

Interventions

  • DrugTeriparatide
  • Drugplacebo
06

What researchers measure

Primary outcomes

  1. Time to radiographic healing

Secondary outcomes

  1. There are no secondary outcomes for this trial

07

Study locations

7 sites
  • 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
  • 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
08

References and documents

Publications

  • 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. PubMed 19594305 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00190944
Lead sponsor
Eli Lilly and Company
First posted
Sep 19, 2005
Start date
Dec 2004
Completion
Jun 2007
Last update
Oct 12, 2007

Study contacts

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 · Eli Lilly and Company
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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