Trial to Evaluate Tibolone in the Treatment of Osteoporosis (P06468) (LIFT)

Organon

Status and phase

Completed

Phase 3

Conditions

Osteoporosis

Treatments

Drug: Tibolone

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00519857

32962

P06468

Details and patient eligibility

About

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.

Enrollment

4,534 patients

Sex

Female

Ages

60 to 85 years old

Volunteers

No Healthy Volunteers

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