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Main
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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. |
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Register:
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EUCTR |
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Last refreshed on:
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30 April 2019 |
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Main ID: |
EUCTR2010-019656-41-GB |
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Date of registration:
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15/07/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of Zoledronic acid on making blood vessels stiff in women by comparing twins, where one is taking the medicine and the other is taking a placebo
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Scientific title:
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Effects of Zoledronic Acid on arterial calcification and arterial stiffness in women – a co-twin randomised double blind, placebo-controlled parallel group, clinical trial - Effects of zoledronic acid on arterial calcification/stiffness Vers2.1 |
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Date of first enrolment:
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24/08/2011 |
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Target sample size:
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220 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019656-41 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Professor P J Chowienczyk
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Address:
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Clinical Pharmacology, North Wing, St Thomas' Hospital
SE1 7EH
London
United Kingdom |
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Telephone:
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004402071884642 |
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Email:
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phil.chowienczyk@kcl.ac.uk |
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Affiliation:
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King's College London |
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Name:
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Professor P J Chowienczyk
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Address:
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Clinical Pharmacology, North Wing, St Thomas' Hospital
SE1 7EH
London
United Kingdom |
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Telephone:
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004402071884642 |
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Email:
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phil.chowienczyk@kcl.ac.uk |
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Affiliation:
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King's College London |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Monzygotic female twin pairs from the Twins UK cohort; dizygotic twin pairs will also be recruited from the same cohort if the initial recruitment of monozygotic twins pairs is inadequate.
Written informed consent
Age > 50 years.
T-score for femoral neck BMD < -1.0 and > -2.5
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 220
Exclusion criteria:
Women already on treatment with a bisphosphonate or who have been treated with a bisphosphonate in the last 5 years.
Women for whom there is a clinical indication for treatment with a bisphosphonate.
Known intolerance to bisphosphonates.
Renal impairment with estimated glomerular filtration rate < 35 ml/hr.
Corrected serum calcium < 2.0 mmol/L or > 2.8 mmol/L.
Hyper or hypoparathyroidism.
Thyrotoxicosis or untreated hypothyroidism.
Other metabolic bone disease (other than osteoporosis).
Clinically significant liver function abnormalities.
Clinically significant haematological abnormalities other than mild anaemia (Hb>10.0 g/dl).
Active malignancy.
Participation in a CTIMP within the last four months.
Pregnancy or lactation.
Ongoing dental problems.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Arterial stiffness and arterial calcification
MedDRA version: 14.0
Level: LLT
Classification code 10059123
Term: Arterial calcification
System Organ Class: 10047065 - Vascular disorders
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Intervention(s)
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Trade Name: Aclasta® 5 mg solution for infusion
Pharmaceutical Form: Solution for injection
INN or Proposed INN: zoledronic acid monohydrate
CAS Number: 165800-06-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous drip use (Noncurrent)
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Primary Outcome(s)
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Main Objective: Does Zoledronic Acid 5 mg once yearly compared to placebo reduces arterial stiffness?
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Primary end point(s): Reduction in arterial stiffness over time.
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Secondary Objective: Does the administration of Zoledronic Acid within the same cohort reduce the progression, or reversal of arterial calcification? If no presence of arterial calcification is initially detected, does the use of Zoledronic Acid prevent the condition from occuring?
Does Zoledronic acid reduce the change in carotid intima-media thickness from baseline to final visit in the active treatment group compared to placebo group?
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Timepoint(s) of evaluation of this end point: 3 years
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 3 years
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Secondary end point(s): Secondary outcomes will be arterial calcification (as measured by aortic CT), common carotid intima-media thickness (CIMT) and high sensitivity CRP (hsCRP).
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Secondary ID(s)
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ZA/CP/0210
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Source(s) of Monetary Support
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NIHR ARTISTIC programme award to artherosclerosis theme
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Ethics review
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Status: Approved
Approval date:
Contact:
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