The Relationship between Osteoporosis and Aortic Calcification in Postmenopausal Women

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2008-001865-28-GB
• Date of registration: 04/04/2008
• Prospective Registration: Yes
• Primary sponsor: King's College London
• Public title: The Relationship between Osteoporosis and Aortic Calcification in Postmenopausal Women
• Scientific title: The Relationship between Osteoporosis and Aortic Calcification in Postmenopausal Women - Osteoporosis and Aortic Calcification
• Date of first enrolment: 30/05/2008
• Target sample size: 50
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001865-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Calcium and vitamin D supplements Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

United Kingdom

Contacts

• Name: Osteoporosis Unit
• Affiliation: King's College London

• Name: Osteoporosis Unit
• Affiliation: King's College London

Key inclusion & exclusion 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 < -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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

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

Intervention(s)

Product Name: Alendronic acid
Pharmaceutical Form: Tablet
CAS Number: 121268175
Other descriptive name: ALENDRONATE SODIUM
Concentration unit: IU/mg international unit(s)/milligram
Concentration type: equal
Concentration number: 70-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Baseline, month 3, month 6, month 12, month 18, month 24

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.

Main Objective: To evaluate the effects of bisphosphonate alendronate on aortic calcification in postmenopausal women with osteoporosis and severe osteopenia.

Primary end point(s): Changes in pulse wave velocity (aortic stiffness).
Changes in aortic calcification.

Secondary Outcome(s)

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

Secondary ID(s)

08/H0802/9

Source(s) of Monetary Support

King's College London

Guy's & St Thomas' NHS Foundation Trust

National Osteoporosis Society

Secondary Sponsor(s)

Guys and St Thomas NHS Foundation Trust

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 08/11/2018
• Date Completed: 24/10/2014
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2008-001865-28/results