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

Phase 1

• Conditions: Arterial stiffness and arterial calcification; MedDRA version: 14.0 Level: LLT Classification code 10059123 Term: Arterial calcification System Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-019656-41-GB
• Lead Sponsor: King’s College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-15
• Study Completion: 2014-10-21
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 99999

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified