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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019656-41-GB

Enrollment

220

Registered

2011-07-15

Start date

2011-08-24

Completion date

Unknown

Last updated

2019-04-30

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

Conditions

Arterial stiffness and arterial calcification MedDRA version: 14.0 Level: LLT Classification code 10059123 Term: Arterial calcification System Organ Class: 10047065 - Vascular disorders

Interventions

Trade Name: Aclasta® 5 mg solution for infusion Pharmaceutical Form: Solution for injection INN or Proposed INN: zoledronic acid monohydrate CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

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 -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

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 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Does Zoledronic Acid 5 mg once yearly compared to placebo reduces arterial stiffness? ; 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? ;Primary end point(s): Reduction in arterial stiffness over time.;Timepoint(s) of evaluation of this end point: 3 years	—

Measure

Time frame

Main Objective: Does Zoledronic Acid 5 mg once yearly compared to placebo reduces arterial stiffness? ; 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? ;Primary end point(s): Reduction in arterial stiffness over time.;Timepoint(s) of evaluation of this end point: 3 years

—

Secondary

Measure	Time frame
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).;Timepoint(s) of evaluation of this end point: 3 years	—

Countries

United Kingdom

Contacts

Public ContactProfessor P J Chowienczyk

King's College London

phil.chowienczyk@kcl.ac.uk004402071884642

Outcome results

None listed

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