Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multinational, Multicenter, Randomized, Double-Blind, Parallel Group,Placebo Controlled Clinical Trial of the Effects of Tibolone (Org OD-14 1.25mg) on the Incidence of New Vertebral Fractures in Osteoporotic Postmenopausal Women.
Brief Summary: Tibolone 1.25 mg is an effective treatment for the prevention of osteoporosis and is expected to be effective in preventing fractures in osteoporotic women. Tibolone could be more acceptable for long-term use, in particular since it does not induce a regular withdrawal bleed.

The objective of this trial is to compare placebo and tibolone, a steroid with tissue specific activity, in the prevention of spinal fractures in women meeting the WHO criteria for osteoporosis or who have asymptomatic vertebral fractures.


Options:
A: Inclusion Criteria:

* Voluntary written informed consent, and who were willing and able to make reasonable efforts to observe all clinical trial requirements were to be enrolled
* Subjects were to be postmenopausal (naturally or surgically) women, from 60 to 85 years of age (inclusive) at entry
* Screening BMD of the total hip and/or spine had to be equal to or lower than 2.5 SD T-score for subjects without an asymptomatic fracture or equal to or lower than -2.0 SD T-score for subjects with an asymptomatic fracture
* Subjects were to have a Body Mass Index (BMI) = 34 kg/m\^2.

Exclusion Criteria:

Subjects with any of the following conditions were not to be enrolled into the trial:

* Recent acute vertebral fracture (diagnosed within the last year) documented by spinal radiograph requiring medication for osteoporosis treatment, in the judgment of the investigator
* More than two prevalent asymptomatic vertebral fractures at baseline
* Screening BMD of the total hip or spine lower than -4 SD T-score
* Unsuitable anatomy on spinal radiographs (lumbar and thoracic vertebrae) e.g., excessive scoliosis
* Not ambulatory
* History or presence of any malignancy within the past five years except for nonmelanoma skin cancer. Subjects with ever history of ovarian cancer or estrogen dependent tumors particularly breast or endometrial cancer were to be excluded
* Trans vaginal ultrasound (TVUS) endometrial double wall thickness \>4 mm
* Unexplained abnormal vaginal bleeding in the past year prior to screening
* Abnormal cervical Papanicolaou (Pap) smear (including low grade squamous intraepithelial lesion (LSIL), high grade squamous intraepithelial lesion (HSIL), atypical squamous cells of undetermined significance (ASCUS), atypical glands of undetermined significance (AGCUS))
* Mammography finding that was suspicious of malignancy
* Bone disease other than osteoporosis such as Paget's disease, osteomalacia, hyperparathyroidism, or bone metastases
* Treatment with anabolic steroids, calcitonin, raloxifene, tamoxifen, or calcitriol within the last six months prior to screening BMD or spinal X-ray measurements.
* Treatment with systemic estrogen and/or progestin within the last three months prior to screening BMD or spinal X-ray measurements (occasional use of estriol containing vaginal cream was allowed)
* Treatment with bisphosphonates for one month or more within the last year
* Ever use of estrogen and/or progestin containing implants
B: 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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C: Inclusion Criteria:

* Female, 65-89 years old
* No history of severe liver, kidney or eye disease

Exclusion Criteria:

* Current bisphosphonate users such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel® (risedronate), Skelid® (tiludronate)
* Using hip protectors

Other protocol-defined inclusion/exclusion criteria may apply.
D: Inclusion Criteria:

* Patients with type II diabetes mellitus as defined by 1999 World Health Organisation criteria.
* Glycated haemoglobin (HbA1c) \>7.0 % to = 9.0 % at visit 1.
* Use of an oral glucose lowering agent for a minimum of 6 months prior to screening and unchanged for 2 months prior to screening.
* Body mass index \>25.0 kg/m2.

Exclusion Criteria:

* Patients receiving any other glucose lowering therapy which is not metformin or a sulfonylurea.
* Patients with systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg.
* Patients who have required the use of insulin for glycaemic control at any time in the past.
* Hospitalisation for any major cardiovascular event in the last 3 months.

Answer: A