NCT00431431

Brief Summary

Both tibolone and raloxifene have been demonstrated to prevent postmenopausal bone loss. During treatment with tibolone bone mineral density (BMD) of the spine has been shown to be increased between 1.8 and 5.8 % above baseline in two years, depending on the population studied. Since treatments aimed at prevention should ideally be used long-term, compliance with the treatment is crucial. Efficacy of and compliance with the two treatments will be measured and evaluated.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2000

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2000

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2007

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

4.5 years

First QC Date

February 2, 2007

Last Update Submit

August 13, 2024

Conditions

Osteopenia

Outcome Measures

Primary Outcomes (1)

  • Measure BMD to evaluate the effects of treatment on bone mineral density of the lumbar vertebrae L1-L4

    At screening, after 52 weeks and 104 weeks

Secondary Outcomes (6)

  • To measure the effects on hot flushes by using diary booklets

    Throughout trial and up to week 52

  • To measure the economic impact during the whole trial period by using Medical resource utilization forms

    Baseline and week 52 and 104

  • Bone mineral density of the total hip

    At screening, week 52 and week 104

  • A vaginal smear to determine vaginal atrophy

    At screening, week 52 and week 104

  • Biochemical markers of bone metabolism

    At baseline, week 12, week 24, week 52 and week 104

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

tibolone

Drug: tibolone

2

ACTIVE COMPARATOR

raloxifene

Drug: raloxifen

Interventions

tiboloneDRUG

2 years treatment with tibolone (1.25 mg Org OD-14)

1
raloxifenDRUG

2 years treatment with raloxifene (60 mg)

2

Eligibility Criteria

Age60 Years - 79 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Only subjects who give voluntary written informed consent, and who are willing and able to make reasonable efforts to observe all clinical trial requirements are to be enrolled.
  • Subjects will be osteopenic but otherwise healthy postmenopausal women, from 60 to 79 years of age (inclusive) at entry.
  • Screening BMD of the lumbar vertebrae (L1-L4) must be between -2.5 SD and
  • SD of the T-score.
  • Subjects should have a Body Mass Index (BMI) \>19 and \< 30 kg/m2.

You may not qualify if:

  • Spinal X -ray with symptomatic vertebral fracture (more than 20% reduction in expected vertebral height).
  • History of bilateral hip replacements.
  • Subjects who are not ambulatory.
  • History or presence of any malignancy, except non-melanoma skin cancers.
  • TVUS double wall thickness \> 4 mm, or any other undiagnosed abnormalities visualized by TVUS.
  • Abnormal cervical Pap smear result
  • Undiagnosed abnormal (in the investigator's opinion) vaginal bleeding in the past year prior to screening.
  • Mammography or physical examination finding that is suspicious of malignancy.
  • Uncontrolled hypertension
  • Bone disease other than osteoporosis such as Paget's disease, osteomalacia or bone metastases.
  • Drinking more than 4 glasses of alcohol containing drinks per day.
  • Smoking more than 20 cigarettes a day.
  • Current or recent prolonged use of hepatic microsomal enzyme-inducing anticonvulsant medication or other drugs known to interfere with or otherwise alter the pharmacokinetics of steroids.
  • Treatment with anabolic steroids, calcitonin or raloxifene within the last 6 months.
  • Treatment with alendronate and risedronate more than 6 months. If treatment duration was less than 6 months a wash-out period of 12 months is necessary.
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Delmas PD, Davis SR, Hensen J, Adami S, van Os S, Nijland EA. Effects of tibolone and raloxifene on bone mineral density in osteopenic postmenopausal women. Osteoporos Int. 2008 Aug;19(8):1153-60. doi: 10.1007/s00198-007-0545-3. Epub 2008 Feb 7.

    PMID: 18256777RESULT

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

tibolone

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2007

First Posted

February 5, 2007

Study Start

July 31, 2000

Primary Completion

February 15, 2005

Study Completion

February 15, 2005

Last Updated

August 15, 2024

Record last verified: 2022-02