Study of AZD4017 on markers of bone turnover in post-menopausal osteopaenia

• Conditions: Post-menopausal Osteopaenia; MedDRA version: 16.1Level: PTClassification code 10049088Term: OsteopeniaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-003387-32-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-29
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1.Provision of informed consent prior to any study specific procedures.

2.Aged >50 and post-menopausal based on amenorrhoea for >12 months.

3.Documented presence of osteopaenia (bone density T-score at lumbar spine or hip of less than -1 and greater than -2.5 by Dual-energy X-ray Absorptiometry (DXA) criteria).

4.Placebo treatment for the duration of the study must not be considered detrimental to the study subject.

5.Must be able to understand the patient information sheet and consent form and comply with study requirements.

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Bone Related Exclusion Criteria:
1Clinical or biochemical evidence of secondary causes of bone loss

2.25-OH vitamin D level <20nmol/L

3.The current or recent use (within 2 years) of medication likely to have an impact on bone (oestrogens, aromatase inhibitors, bisphosphonates, fluoride, denosumab, strontium ranelate, anti-convulsants, teriparatide; and oral, inhaled or nasal glucocorticoids). Patients already on calcium/vitamin D supplementation will continue this for the study. Those with a 25-OH vitamin D level of 20-50nmol/L at screening will be supplemented prior to inclusion.

General Exclusion Criteria:
1.Women of child-bearing potential.

2.eGFR calculated by MDRD equation <60ml/min/1.73m2.

3.Any endocrine disorder, eg, thyroid dysfunction.

4.Suspicion of or known Gilbert's disease.

5.CK >twice upper limit normal on 2 consecutive measurements.

6.Liver transaminases > upper limit normal.

7.Alkaline phosphatase > upper limit normal.

8.Bilirubin (total) > upper limit normal.

9.User of recreational or illicit drugs (including marijuana) or has had a recent history (within the last year) of drug or alcohol abuse or dependence.

10.Uncontrolled systemic hypertension (BP >150/90); on 3 successive measurements on the morning of the screening visit.

11.Systemic (including vaginal/rectal) or inhaled glucocorticoid treatment at the time of the screening visit.

12.Probenicid therapy at the time of the screening visit.

13.Any screening laboratory abnormality that, in the investigator’s judgement, is considered to be clinically significant

14.History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject’s ability to participate in the study. Specifically, a diagnosis of any inflammatory disorder that might reasonably need treatment with glucocorticoids during the course of the study.

15.History of any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.

16.Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP as judged by the investigator.

17.Hypersensitivity or intolerance to 11ß-HSD1 antagonists or to AZD4017.

18.Involvement in the planning and/or conduct of the study

19.Participation in any other clinical study within 1 month prior to the screening visit.

20.Previous randomisation for treatment in the present study.

Study & Design

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