Clinical trial: Trial to Evaluate Tibolone in the Treatment of Osteoporosis (P06468) (NCT00519857)

Eligibility criteria:
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
Female
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? Contradiction