Please select the eligibility criteria that correspond to the clinical trial below.
Title: Proprietary Information - Exploratory (Non-Confirmatory) Trial
Brief Summary: The purpose of this study is to demonstrate an improvement in physical functional recovery, following administration of Drug for 24 weeks, in patients who have recently experienced a hip fracture. This study will also evaluate the safety and tolerability of Drug.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).


Options:
A: Inclusion Criteria:

* Hip fracture

Exclusion Criteria:

* Male
* Under 65 years old
* Non-surgical repair of hip fracture
* Non-community dwelling
* Fractured more than 72 hours before admission to the hospital
* Pathologic fracture
* Resides more than 70 miles from the hospital of admission
* Recent diagnosis (in past 6 months) of angina or myocardial infarction
* Myocardial infarction or stroke concurrent with hip fracture
* Diagnosis of ventricular arrhythmia, third degree heart block, atrial fibrillation or if vital signs equal heart less than 60 or greater than 100
* Active or suspected myocarditis or pericarditis in the past year
* Recent (within past 6 months) deep venous thrombosis or intracardiac thrombi
* Persistent pulmonary edema during hospitalization
* Poorly controlled blood pressure w/ resting systolic greater than 180 mm Hg or resting diastolic greater than 100 mm Hg (3 or more readings with 24- hour period)
* Presence of ventricular aneurysm
* Paget's Disease
* Diabetes--blood sugar consistently greater than 300
* Diagnosis of thyrotoxicosis or myxedema within past year
* Any diagnosis of hyperparathyroidism, hypoparathyroidism, or osteomalacia
* Parkinson's, multiple sclerosis, or ALS (Lou Gehrig's disease)
* New (past 6 months) onset seizure disorder or seizure within the past 6 months
* Diagnosis of schizophrenia
* Recent (within past 6 months) GI hemorrhage or bleeding
* Preadmission coumadin therapy
* Cirrhosis or end stage renal disease (ESRD)
* Advanced hepatitis, AIDS, or endocarditis
* Cancer with metastases, or cancer under active treatment (chemotherapy with cytotoxic agents) other than non-melanomic skin cancers
* Current diagnosis of chronic alcohol abuse
* Preadmission narcotic use or preadmission benzodiazepine use more than 1 dose or tablet a day
* Required human assistance to walk prior to fracture
* Prior fracture
* Chest pains when climbing a flight of stairs, while walking on level ground, or at rest prior to the hip fracture
* Use of supplemental oxygen prior to fracture
* Other (Non-English speaking, severe blindness, paraplegia, hemiplegia
* Mini-Mental Status Exam score less than 20
B: Inclusion Criteria:

* Patient has had surgery for a unilateral hip fracture, and is considered to be partially or fully weight bearing after the surgery
* Surgical repair of the fracture has occurred no more than 4 days post hip fracture
* Prior to starting the study medication, the patient is enrolled in a rehabilitation program (as an in-patient or as an out-patient)
* Patient is judged to have been able to ambulate independently at home prior to their hip fracture (able to walk indoors in a familiar setting with little or no aid from another person)

Exclusion Criteria:

* Patient has an unstable medical condition
* Patient has a hip fracture that is due to bone pathology other than osteoporosis (e.g., malignancy, or Paget's Disease), or major trauma (e.g. motor vehicle accident).
* Patient has Type I diabetes
* Patient has Type II diabetes with any of conditions;

  1. Patient is currently taking more than one anti-hyperglycemic agent, or is taking a single combination anti-hyperglycemic drug containing more than one anti-hyperglycemic medication
  2. Patient is currently receiving insulin. Note: A short-term course of insulin required for glycemic control post hip fracture surgery is not exclusionary
  3. Patient has diabetic retinopathy
  4. Patient is unwilling or unable to monitor glucose at home
* Patient has been diagnosed with any neuromuscular or neurological disease causing muscle weakness
* Patient has cancer, or had a diagnosis of any malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or adequately treated in situ cervical cancer
* Patient has active carpal tunnel syndrome
* Patient was living in a nursing home prior to the hip fracture (Note: - Patients who were living in an assisted-living facility prior to the hip fracture are eligible for enrollment)
* Patient was permanently wheelchair bound prior to the hip fracture
C: Inclusion Criteria:

* After the first hip fragility fracture following a fall from standing height or while turning
* Surgically treated in the later stage of rehabilitation phase (6 months up to 2 years after the fracture).

Exclusion Criteria:

* Sustained a hip fracture trauma due to falls from higher surfaces or motor vehicle accidents or due to a tumors or disease (other than osteoporosis)
* Several cognitive impairment, assessed by Mini-Mental State Examination adjusted for educational level \[22\];
* Inability to walk, either with walking aid;
* Progressive or severe neurological disease (e.g., Parkinson's disease, stroke);
* Communication disability (several uncompensated visual or hearing deficits);
* Medical condition contraindications exercise (e.g. unstable angina, severe valvular heart disease, large or expanding aortic aneurysm, etc.) \[23\];
* Engaged in a regular exercise program, with a frequency more or equal than twice a week, 30 minutes a day (excluding walking and senior dance) \[24\].
D: Inclusion Criteria:

* Home dwelling prior to fracture
* age\>70yr
* able to walk 10m

Exclusion Criteria:

* expected life expectancies \<3 months
* exercises contraindicated due to medical conditions

Answer: B