Please select the eligibility criteria that correspond to the clinical trial below.
Title: Calcium and Vitamin D Malnutrition in Elderly Women
Brief Summary: This study is designed to test whether calcium supplementation alone or calcium plus vitamin D reduces the incidence of fractures, reduces high parathyroid secretory activity, and halts bone loss in a population-based sample of women 55+ years of age.

* A calcium supplement of 1400 mg/d will significantly reduce the cumulative incidence of spine and appendicular fractures over four years for independently living, rural women 55 years of age and older compared to similar women on their usual diets.
* A calcium supplement of 1400 mg/d plus 1100 IU vitamin D/d will significantly reduce the cumulative incidence of spine and appendicular fractures compared to a calcium supplement only.


Options:
A: Inclusion Criteria: healthy women ages 55 and older who were at least four years postmenopausal living independently in a nine-county rural area of Nebraska

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Exclusion Criteria:

1) chronic kidney disease, 2) Paget's metabolic bone disease, and 3) history of cancer except for superficial basal or squamous cell carcinoma of the skin and

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B: Inclusion Criteria:

* Aged over 65 years with normal renal function
* Normal transaminase levels
* Normal calcium blood levels
* Not homebound (not immobilized) nor in socio-healthcare institutions.

Exclusion Criteria:

* Need for medical treatment with calcium or vitamin D
* Hypersensitivity to or contraindication for calcium or vitamin D
* Medical treatment that includes calcium or vitamin D
* Physical disability that impedes their collaboration
* Taking thiazide diuretics
* Oral anticoagulants
* Hormone replacement therapy
* Digitalis drugs
* Anticonvulsants or barbiturates
* Having any of the following diseases:

  * Lithiasis
  * Renal impairment (serum creatinine \>1.4 mg/dl)
  * Hypo or hyperthyroidism
  * Paget's disease
  * Chronic liver disease
  * Tumors
  * Sarcoidosis
  * Impaired intestinal absorption or chronic alcoholism (\>40 g/day).
C: Inclusion Criteria:

1. Community dwelling men and women age ≥ 65 years.
2. Able and willing to sign informed consent.
3. Serum 25OHD concentration ≥ 10 and less than 60 ng/ml by HPLC.
4. Willing to avoid use of cod-liver oil and non-study vitamin D supplementation; standard multiple vitamins containing ≤ 400 IU used no more than once daily will be allowed

Exclusion Criteria:

1. Current hypercalcemia (serum calcium \> 10.5 mg/dl) or untreated primary hyperparathyroidism.
2. History of nephrolithiasis.
3. Screening 25OHD concentration ≥ 60 ng/ml.
4. Baseline 24-hour urine calcium \> 250 mg if female, \> 300 mg if male.
5. Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis, Paget's disease
6. History of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin cancer.
7. Renal failure defined as a calculated creatinine clearance (Cockroft-Gault method) ≤ 25 ml/minute
8. Severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which may limit ability to complete the study
9. Known malabsorption syndromes, e.g., celiac disease, radiation enteritis, active inflammatory bowel disease, etc.
10. Use of medications known to alter bone turnover including bisphosphonates, estrogen, selective estrogen receptor modulators, PTH, testosterone or calcitonin
11. Vitamin D intake greater than 5,000 IU daily
12. Treatment with any active metabolites of vitamin D within six months of screening
13. Treatment with any drug which may interfere with vitamin D metabolism, e.g., phenobarbital, phenytoin.
D: Inclusion Criteria:

* At least 7 years post-menopause
* Serum 25OHD level 5 ng/ml to 20 ng/ml
* BMI less than or equal to 40 kg/m2
* Willing to discontinue multivitamins that contain vitamin D during the study

Exclusion Criteria:

* Cancer (except basal cell carcinoma) or terminal illness
* Previous hip fracture
* Hemiplegia (paralysis of one side of the body)
* Uncontrolled type I diabetes or fasting blood sugar greater than 140 mg in type II
* Kidney stones more than twice in a lifetime
* Chronic renal failure
* Evidence of chronic liver disease, including alcoholism
* Physical conditions such as severe osteoarthritis, rheumatoid arthritis, heart failure severe enough to prevent reasonable physical activity
* Previous treatment with bisphosphonates (more that 3 months), PTH or PTH derivatives, (e.g. Teriparatide or Fluoride) in the last 6 months
* Previous treatment within the last 6 months with calcitonin or estrogen
* Chronic high dose corticosteroid therapy (more than 10 mg per day) for over 6 months and not within the last 6 months
* Anticonvulsant therapy
* High dose thiazide therapy (more than 37.5 mg)
* 24 hour urine calcium greater than 290 mg on 2 baseline tests
* Serum calcium exceeding upper normal limit on 2 baseline tests
* Bone Mineral Density T-score less than -3.0 for spine or hip

Answer: A