A Study in Older Patients Undergoing Elective Total Hip Replacement

• Register: EUCTR
• Last refreshed on: 17 March 2014
• Main ID: EUCTR2011-000426-29-FI
• Date of registration: 19/07/2011
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study in Older Patients Undergoing Elective Total Hip Replacement
• Scientific title: A Phase 2 Randomized Study to Investigate the Efficacy and Safety of LY2495655 Versus Placebo in Older Patients Undergoing Elective Total Hip Arthroplasty (eTHA) - JDDE
• Date of first enrolment: 06/09/2011
• Target sample size: 384
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000426-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4

Countries of recruitment

Canada, Denmark, Estonia, Finland, France, Japan, Sweden, United States

Contacts

• Name: Clinical Trial Information
• Affiliation: Eli Lilly

• Name: Clinical Trial Information
• Affiliation: Eli Lilly

Key inclusion & exclusion criteria

Inclusion criteria:
Males or females age 50 years or older.

Elective total hip arthroplasty (eTHA) is scheduled.

Have a body mass index of <40 kg/ m² and a weight <136.4 kg.

Can climb at least 6 stairs with or without holding the handrail (but without human assistance), according to the patient at the screening visit.

Can stand up from a chair and walk more than 10 meters without human assistance

Take at least 12 seconds to perform the Timed Up and Go (TUG) test at the screening visit.
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 324

Exclusion criteria:
1. Another inpatient surgical procedure is planned in the 6 months following the randomization visit.
2. Lower extremity amputation.
3. Lower limb fracture within 6 months prior to the screening visit or any major lower limb surgery within 3 months prior to randomisation.
4. Simultaneous bilateral eTHA.
5. The planned surgical procedure will preclude weight bearing for at least 4 weeks postoperatively (for instance, the planned procedure will involve extensive bone grafting). “Partial weight bearing” and “weight bearing as tolerated” are acceptable, but “non weight-bearing,” “touch weight bearing,” or “feather weight bearing” are exclusive.
6. Underlying muscle disease (for example, polymyositis or muscular dystrophy) or a history of muscle disease other than age-associated muscle waste or disuse atrophy.
7. Recent neurologic injury (<6 months prior to randomization) such as stroke or spinal cord injury, or unstable neurologic disorders that are likely to confound physical performance tests during the course of the study (such as unstable Parkinson disease or hemiplegia).
8. History of positive testing for human immunodeficiency virus (HIV).
9. Current use or previous use of any drugs known to influence muscle mass or performance within 6 months prior to randomization (this includes anabolic steroids, replacement therapy for gonadal deficiency, anti-androgens, luteinizing hormone-releasing hormone (LHRH) agonists and antagonists, growth hormone, IGF1, or creatine supplements), or systemic corticosteroid use for at least 3 months (in the last year) prior to randomization at a daily dose =10 mg prednisone equivalent.
10. Severe Vitamin D deficiency defined as 25-hydroxy-vitamin D levels <9.2 ng/mL or <23 nmol/L at the screening visit.
11. History of a malignant neoplasm in the 5 years prior to the screening visit, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to screening may enter the study.
12. History of any of the following conditions within 90 days of the screening visit: Unstable angina, myocardial infarction, coronary artery bypass graft surgery, or percutaneous coronary intervention (eg, angioplasty or stent placement).
13. Any current supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate >100 beats per minute) at rest despite medical or device therapy, or any history of spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for 30 seconds) despite medical or device therapy, or any history of resuscitated cardiac arrest or the presence of an automatic internal cardioverter-defibrillator.
14. Any history of congestive heart failure within 6 months of the screening visit.
15. Systolic blood pressure >160 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg at randomisation visit (if stress is suspected, retest under basal conditions), or malignant hypertension.
16. An abnormality in the locally read 12-lead electrocardiogram (ECG) that in the opinion of the investigator increases the risk of participating in the study.
17. Have either or both of the following: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 times the upper limit of normal (ULN), or alkaline phosphatase >1.5 times ULN, or total bilirubin >1.5 times ULN. The liver tests above may be re

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Disuse atrophy
MedDRA version: 14.1 Level: LLT Classification code 10013521 Term: Disuse muscle atrophy System Organ Class: 100000004859

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

Intervention(s)

Product Name: LY2495655 for Injection
Product Code: LY2495655
Pharmaceutical Form: Lyophilisate for solution for injection
Current Sponsor code: LY2495655
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 53-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: The primary objective of this study is to test the hypothesis that appendicular lean body mass (aLBM) will increase after 12 weeks of LY2495655 treatment versus placebo in older patients undergoing elective total hip arthroplasty (eTHA).

Primary end point(s): Change from baseline in appendicular lean body mass.

Secondary Objective: see Exploratory objectives in the study protocol.

Timepoint(s) of evaluation of this end point: 12 weeks after the first injection

Secondary Outcome(s)

Secondary end point(s): pls see in the study protocol: exploratory endpoints

Timepoint(s) of evaluation of this end point: pls see in the study protocol: exploratory endpoints

Secondary ID(s)

I1Q-MC-JDDE

Source(s) of Monetary Support

Eli Lilly and Company