NCT00262392

Brief Summary

The purpose of this study is to determine whether Bisphosphonates in comparison to radiation therapy are effective in the prophylaxis and treatment of heterotopic ossification in high risk patients.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2005

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

5 years

First QC Date

December 5, 2005

Last Update Submit

March 9, 2015

Conditions

Heterotopic Ossification

Keywords

heterotopic ossification,prevention,high risk,bisphosphonates,radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint is the radiological Heterotopic Ossification recurrence rate.

    6 month

Secondary Outcomes (1)

  • Secondary endpoints are the clinical, functional and biochemical outcome (as assessed by several clinical and laboratory markers).

    6 month

Study Arms (2)

Pamidronate

EXPERIMENTAL

Pamidronate

Drug: Pamidronate (AREDIA)

radiation

ACTIVE COMPARATOR

radiation

Drug: Pamidronate (AREDIA)

Interventions

Pamidronate (AREDIA)DRUG

Pamidronate (AREDIA) vs radiation

Pamidronateradiation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients with established HO (Brooker grade III-IV), hospitalized for resection of HO lesions

You may not qualify if:

  • Age \<20 years
  • Vitamin D deficiency (25OH-Vitamin D \<30 ng/ml)
  • Renal insufficiency (Clearance \<50 ml/min)
  • Intolerance of bisphosphonates
  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Schuetz P, Mueller B, Christ-Crain M, Dick W, Haas H. Amino-bisphosphonates in heterotopic ossification: first experience in five consecutive cases. Spinal Cord. 2005 Oct;43(10):604-10. doi: 10.1038/sj.sc.3101761.

    PMID: 15867938BACKGROUND

MeSH Terms

Conditions

Ossification, Heterotopic

Interventions

Pamidronate

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • philipp schuetz, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

  • Christian Meier, MD

    University Hospital in Basel

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2005

First Posted

December 6, 2005

Study Start

June 1, 2005

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

March 10, 2015

Record last verified: 2015-03