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-SE

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.