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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	25 November 2019
Main ID:	EUCTR2007-005647-14-GB
Date of registration:	22/02/2008
Prospective Registration:	Yes
Primary sponsor:	Cardiff University
Public title:	Gamma Delta T Cells and their role in the acute phase reaction to intravenous bisphosphonates
Scientific title:	Gamma Delta T Cells and their role in the acute phase reaction to intravenous bisphosphonates
Date of first enrolment:	16/03/2009
Target sample size:	120
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005647-14
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:	Human pharmacology (Phase I): Therapeutic exploratory (Phase II): Therapeutic confirmatory - (Phase III): Therapeutic use (Phase IV): yes

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion 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:
Unable to give informed consent
Poor venous access

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Trade Name: Bonviva
Pharmaceutical Form: Injection*
Other descriptive name: IBANDRONIC ACID MONOSODIUM SALT, MONOHYDRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-

Trade Name: Aclasta
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: ZOLEDRONIC ACID
CAS Number: 118072938
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Primary end point(s): donation of blood sample(s) for analysis of gamma delta t cell response

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:

Secondary Outcome(s)

Secondary ID(s)

07/cmc/4088e

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Results

Results available:	Yes
Date Posted:	29/06/2019
Date Completed:	14/05/2008
URL:	https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-005647-14/results

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