Osteoporosis and Paget's disease
Conditions
Interventions
Product Name: Zoledronate (Aclasta)
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Zoledronate
Concentration unit: mg milligram(s)
Sponsors
Research and Development Office Cardiff and Vale NHS Trust
Research and Development Office Cardiff and Vale NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed