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Trial · Interventional

CompletedPhase 2Registry data

Effects of Teriparatide on Distal Radius Fracture Healing

NCTNCT00190944 (opens ClinicalTrials.gov in a new tab)Other id8175Other idB3D-MC-GHCN

Overview

Status
Completed
Phase
Phase 2
Enrollment
105 participants
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
5 countries

United States, Mexico, Poland, Romania, Sweden

Start
Dec 2004
Primary completion
Not stated
Completion
Jun 2007
First posted
19 Sept 2005 (estimated)
Last update posted
12 Oct 2007 (estimated)
Conditions
Colles' Fracture

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20042005200620072008
  1. Ph 2

    Effects of Teriparatide on Distal Radius Fracture Healing

    NCT00190944

    Dec 2004 to Jun 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Effects of Teriparatide on Distal Radius Fracture Healing

Interventions

  • TeriparatideDrug
  • placeboDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time to radiographic healing

Secondary outcomes(1)
  1. There are no secondary outcomes for this trial

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2010

3 results

Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures.

Aspenberg et al. 2010Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 368

PMID 19594305DOI 10.1359/jbmr.090731PUB-19594305

Full text at the publisher3 results

Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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