Please select the eligibility criteria that correspond to the clinical trial below.
Title: Early Rehabilitation After Hip Fracture: A Randomized Controlled Trial Comparing Different Vitamin D and Rehabilitation Programs
Brief Summary: The aim of this study is to compare a low versus high intensity physiotherapy early rehabilitation program combined with a low versus high dose vitamin D early rehabilitation program in a randomized controlled trial among elderly patients with acute hip fracture in an acute care setting. The primary outcome to be compared between treatment arms is the rate of falls during a 12-month follow-up. Secondary outcomes are injurious falls, number of persons who fell, low-trauma fractures (at the hip, forearm, humerus, pelvis, ankle, spine, femur, tibia), disability, quality of life (Euro-Qol), mortality and health care utilization. Another secondary outcome will be admission to nursing home compared between treatment arms among subjects, who are community-dwelling prior to the index hip fracture. Admission to nursing home is the marker of loss of independence for the individual, but also triggers high cost for the society.

The study will provide new early rehabilitation guidelines to allocate health care resources efficiently in the acute care setting. Eventually and most importantly, the study will help improve outcomes in patients with hip fractures.


Options:
A: Inclusion Criteria:

* Age 65 years or older
* Acute hip fracture admitted to one hospital center

Exclusion Criteria:

* A Folstein Mini Mental Score of less than 15 as an indicator of significant dementia
* Primary hyperparathyroidism
* Current cancer with wasting or bone metastases
* Hyperparathyroidism
* Sarcoidosis
* A kidney stone in the past 5 years or significant renal disease (creatinine clearance below 15 ml/min)
* Hypercalcemia (albumin adjusted) of more than 2.8 mmol/l
* non-surgical treatment
* no German language skills
* severe hearing or visual impairment
B: Inclusion Criteria:

* BMI 30 - 40
* serum calcium \< 2.55 mmol/L

Exclusion Criteria:

* serious diseases
* reduced kidney function
* renal stone disease
* using psychopharmaca
* using drugs for weight reduction
C: Inclusion Criteria:

* Men or women, between 18 and 65 years of age, who are capable of providing informed consent.
* BMI of 25 to 35 kg/m2.
* Non-smoker (for at least 6 months).
* In good health, as determined by the principal investigator based on medical history and physical examination.
* Clinical laboratory evaluations (including Biochemistry, Hematology, Endocrinology) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator.
* Because of the calorie-restricted diet and radiation exposure from the CT scan, females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile for at least 3 months, or be willing to use an approved method of contraception (which may include use of abstinence; intrauterine device; female condom with spermicide; diaphragm with spermicide; cervical cap with spermicide; oral or transdermal hormonal contraceptives; a condom with spermicide by the sexual partner; or a sterile sexual partner) from 35 days prior to study entry (i.e., Day -1) until 30 days following Study Completion. For all females, the pregnancy test result must be negative at the screening visit and at visits when a CT scan will be done.
* Ability to comprehend and willingness to sign the Informed Consent Form for this study.
* Ability to comply with study restrictions regarding diet and exercise.
* Stable weight (+ 5%) for at least 3 months prior to study entry.

Exclusion Criteria:

* Diabetes mellitus.
* History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders which in the opinion of the investigator would be expected to interfere with the study or increase risk to the subject.
* Participation in any other investigational diet study within 90 days prior to study entry.
* History of a medical or psychological condition or social circumstances that would impair the subject's ability to participate reliably in the study.
* Use within the last six months of medications that can result in significant weight gain or weight loss, including antipsychotics, selective serotonin reuptake inhibitors, anti-epileptic drugs, appetite-suppressants such as phentermine and sibutramine, and the lipase-inhibitor orlistat. (see Appendix 1 for detailed list)
* Active eating disorder.
* History of alcoholism or substance abuse within 5 years prior to study entry.
* Recommendation by a physician to avoid calcium supplements because of a history of kidney stones or other medical condition.
* History of hyperparathyroidism or sarcoidosis.
* Osteoporosis or other medical condition for which a physician has recommended taking a multivitamin or calcium supplementation.
* High calcium intake (more than 2 servings of dairy products per day or taking calcium supplements \> 3x/wk ) for 1 month prior to study start date and for duration of study. (If participant is taking calcium supplement \> 3x/wk or more than 2 servings of dairy products per day, they are eligible to participate if they agree to stop for 1 month prior to study start date and for the duration of the study. Participants will similarly be asked to stop multivitamins as the majority of these supplements contain calcium.)
* General medical conditions that are well-controlled will not be a basis for exclusion in the study. Subjects with uncontrolled conditions that are not adequately controlled or that might pose an unacceptable risk for participation, as clinically determined by the investigators, will be excluded.
D: Inclusion Criteria:

* Daily calcium intake below 800mg/day
* Stable body weight
* Body mass index (BMI) between 27-40kg/m2
* Less than 3 periods of 20 minutes of physical exercise/week
* General good health
* Normal blood pressure values
* Normal cholesterol levels
* Normal thyroid hormone levels
* No participation in another clinical trial within 6 months of screening
* Coffee consumption ≤ 5 cups/day.

Exclusion Criteria:

* Breast feeding, pregnant or menopaused women
* Use of calcium supplements within 30 days of screening
* Cholesterol levels requiring pharmaceutical treatment
* Smoking
* Use of medication that could affect body weight

Answer: A