A Study in Older Patients who have fallen recently and have muscle weakness

Conditions: Disuse atrophy
MedDRA version: 14.1Level: LLTClassification code 10013521Term: Disuse muscle atrophySystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2011-006062-40-DE

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 172

Inclusion Criteria

- Males or females aged 75 years or older.
- Sustained at least 1 fall within 1 calendar year prior to the screening visit.
- Requires greater than or equals to12 seconds to perform a repeated chair stands test or is unable to complete this test at the screening visit.
- Hand grip strength is less than or equal to 37 kg for men or less than or equal to 21 kg for women at the screening visit.
- Can stand up from a chair and walk greater than or equal to10 meters without human assistance at the screening visit.
- Able to climb at least 1 step on a staircase without human assistance according to the patient at the screening visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 172

Exclusion Criteria

- Have a major active vestibular vertigo or a major neurologic disorder severely reducing their mobility.
- Are unable to safely perform the protocol-specified tests of physical performance due to a major visual impairment.
- Severe vitamin D deficiency before the randomization visit.
- Current use or previous use of any drugs known to influence muscle mass or performance.
- Have had a recent neurologic injury.
- Have a history or presence of unstable cardiovascular comorbidities.
- Have a positive fecal occult blood (FOB) test at screening or the patient cannot provide a stool sample for FOB testing prior to randomization.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study, in older patients who have fallen recently and have muscle weakness, is to test the hypothesis that LY2495655 will increase appendicular lean body mass( aLBM) versus placebo 24 weeks after starting treatment.;Secondary Objective: To assess the effects of LY2495655 versus placebo on the following measures of physical function over the course of the study:<br>•Stair climbing (StC)<br>•Repeated chair stands (RCS)<br>•Usual gait speed (uGS) ;Primary end point(s): Change from baseline in appendicular lean body mass.;Timepoint(s) of evaluation of this end point: 24 weeks after the first injection

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Stair climbing<br>Repeated chair stands<br>Usual gait speed;Timepoint(s) of evaluation of this end point: 12, 24 and 36 weeks (after 1st injection)