An in-vitro observational pilot study of the role of gamma delta T cells in the acute phase reaction to intravenous bisphosphonate; in blood samples donated by patients receiving intravenous bisphosphonate treatment for Paget’s disease or Osteoporosis final Version 1.6 - Gamma Delta T cells and the APR to IV bisphosphonate final v1.6

Phase 1

• Conditions: Osteoporosis and Paget's disease

• Registration Number: EUCTR2009-017369-47-GB
• Lead Sponsor: Research and Development Office Cardiff and Vale NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-14
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Inclusion Criteria
Attending outpatients for an infusion of intravenous bisphosphonate, as treatment for osteoporosis or Paget’s disease of bone.
No contraindications to treatment with intravenous bisphosphonates.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria
Mentally or legally incapacitated and unable to give informed consent.
Participation in another therapeutic trial within 20 days of consent
History of hypersensitivity to investigational product
History of illness which might compromise participation
Drug or alcohol abuse
Hypocalcaemia.
Impaired renal function (Cr clearance <35 ml/min)
Current use of Oral steroids or other immunosuppressant

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Patients who are treated with intravenous bisphosphonates frequently report a mild flu like illness after the first dosing (the acute phase reaction). We wish to determine whether this reaction is related to the activity of one particular type of white blood cell.;Secondary Objective: We wish to assess the quality of life of our patients using the EQ5D questionaire;Primary end point(s): Is there a change in activity and numbers of circulating gamma delta T cells when patients receive intravenous bisphosphonate and does this correlate with the patient experiencing an acute phase reaction.