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Gamma Delta T Cells and their role in the acute phase reaction to intravenous bisphosphonates

Gamma Delta T Cells and their role in the acute phase reaction to intravenous bisphosphonates

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-005647-14-GB
Enrollment
120
Registered
2008-02-22
Start date
2009-03-16
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with osteoporosis or Paget's disease of bone MedDRA version: 9.1 Level: LLT Classification code 10031282 Term: Osteoporosis MedDRA version: 9.1 Level: LLT Classification code 10033362 Term: Paget's disease

Interventions

Trade Name: Bonviva Pharmaceutical Form: Injection* Other descriptive name: IBANDRONIC ACID MONOSODIUM SALT, MONOHYDRATE Concentration unit: mg milligra

Sponsors

Cardiff University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Due to receive or currently receiving or have received intravenous bisphosphonates for the treatment of osteoporosis or paget's disease of bone Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: Unable to give informed consent Poor venous access

Design outcomes

Primary

MeasureTime frame
Main Objective: to determine whether the presence acute phase reaction to aminobisphosphonates can be predicted by exanination of the gamma delta T cells of a patient;Secondary Objective: ;Primary end point(s): donation of blood sample(s) for analysis of gamma delta t cell response

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026