The Relationship between Osteoporosis and Aortic Calcification in Postmenopausal Women

The Relationship between Osteoporosis and Aortic Calcification in Postmenopausal Women - Osteoporosis and Aortic Calcification

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001865-28-GB

Enrollment

Registered

2008-04-04

Start date

2008-05-30

Completion date

Unknown

Last updated

2019-02-28

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

Conditions

Osteoporosis

Interventions

Product Name: Alendronic acid Pharmaceutical Form: Tablet CAS Number: 121268175 Other descriptive name: ALENDRONATE SODIUM Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effects of bisphosphonate alendronate on aortic calcification in postmenopausal women with osteoporosis and severe osteopenia.; Secondary Objective: - To examine the relationship between BMD and aortic calcification - 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. - 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. ; Primary end point(s): Changes in pulse wave velocity (aortic stiffness). Changes in aortic calcification. ;Timepoint(s) of evaluation of this end point: Baseline, month 3, month 6, month 12, month 18, month 24	—

Measure

Time frame

Main Objective: To evaluate the effects of bisphosphonate alendronate on aortic calcification in postmenopausal women with osteoporosis and severe osteopenia.; Secondary Objective: - To examine the relationship between BMD and aortic calcification - 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. - 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. ; Primary end point(s): Changes in pulse wave velocity (aortic stiffness). Changes in aortic calcification. ;Timepoint(s) of evaluation of this end point: Baseline, month 3, month 6, month 12, month 18, month 24

—

Secondary

Measure	Time frame
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	—

Countries

United Kingdom

Contacts

Public ContactOsteoporosis Unit

King's College London

0044207 1887188

Outcome results

None listed

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