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

Osteoporosis Clinical Trial

— LIFT  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519857
• Other study ID #: P06468
• Secondary ID: 32962
• Status: Completed
• Phase: Phase 3
• Start date: July 2001
• Est. completion date: August 2006

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4534
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Tibolone
1.25 mg p.o, once daily for 3 years
• Placebo
Tablet p.o, once daily for 3 years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy parameter was reduction in incident new vertebral fractures assessed by spinal radiographs (anterior-posterior and lateral)		3 years
Secondary	Bone mineral density of lumbar vertebrae (L1-L4) and left proximal femur for total hip density measured by means of dual-energy X-ray absorptiometry (DXA).		3 years