The Relationship between Osteoporosis and Aortic Calcification in Postmenopausal Wome

Phase 1

• Conditions: Osteoporosis; Aortic Calcification; MedDRA version: 14.1 Level: PT Classification code 10054208 Term: Aortic calcification System Organ Class: 10047065 - Vascular disorders; MedDRA version: 14.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2008-001865-28-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: 2008-04-04
• Study Completion: 2014-10-24
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

Ambulatory postmenopausal women.
Aged 50 years and over.
Lumbar spine, femoral neck or total hip bone mineral density measurement more than 2 standard deviations below the young adult mean for healthy women (T-score < -2).
Normal or clinically insignificant laboratory values.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

Current or recent (within 1 year of enrolment) metabolic bone disorders other than postmenopausal osteoporosis including Paget's disease, renal osteodystrophy, osteomalacia or any other disease known to influence bone metabolism.

Treatment with oestrogens, progestins or selective estrogen receptor modulators (SERMS) for longer than 3 months in the past or within 3 months of study enrolement.

Previous or current use of oral or intravenous bisphosphonates.

Current treatment with corticosteroids, calcitonins, strontium ranelate, anticonvulsants, vitamin D >50,000IU/week, teripatide, PTH 1-84 or any other treatment known to influence bone metabolism.

Current use of lipid lowering agents.

Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia

Hypersensitivity to alendronic acid or to any of the excipients

Hypocalcaemia

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effects of bisphosphonate alendronate on aortic calcification in postmenopausal women with osteoporosis and severe osteopenia.;<br> Secondary Objective: - To examine the relationship between BMD and aortic calcification<br> - To investigate the potential clinical utility of the two non-invasive techniques of PWV measurements and lateral DXA scans of the spine for measuring AC by direct comparison with the gold standard of CT.<br> - To investigate the association between AC and several of the important endocrine and molecular factors that have been implicated in the link between osteoporosis and AC.<br> ;<br> Primary end point(s): Changes in pulse wave velocity (aortic stiffness).<br> Changes in aortic calcification.<br> ;Timepoint(s) of evaluation of this end point: Baseline, month 3, month 6, month 12, month 18, month 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To investigate the potential clinical utility of the two non-invasive techniques of PWV measurements and lateral DXA scans of the spine for measuring AC by direct comparison with the gold standard of CT.;Timepoint(s) of evaluation of this end point: Baseline, month 6, month 12, month 18, month 24