OsteopeniaPhase 4STEPNCT00431431
Comparison of Tibolone and Raloxifene on Bone Mineral Density in Osteopenic Postmenopausal Women (P06090)
A Phase 4 study testing tibolone and raloxifen in people with Osteopenia, run by Organon and Co.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 79 years, women only
- Conditions the study is for
- Osteopenia
- What is being tested?
- tibolone and raloxifen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2000to 15 Feb 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 1.0 SD of the T-score.
- Subjects should have a Body Mass Index (BMI) >19 and < 30 kg/m2.
Who cannot join
- 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
Show all 29Show fewer
- 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.
- Treatment with etidronate for 1 year a wash-out period of 6 months is necessary. If treatment period of more than 1 year a wash -out period of 12 months is necessary.
- Treatment with oral estrogen and/or progestin therapy (including contraceptives) or transdermal therapy and local estrogen applications within 6 months prior to screening/baseline BMD measurements (i.e. the wash -out period of 6 months must have been completed before the screening / baseline BMD assessments are made). A 20-week wash-out for injections of MPA-containing contraceptives (e.g. Depo-Provera®) is required.
- Ever use of estrogen and/or progestin containing implants.
- The use of cholesterol-lowering medicine cholestyramine or colestipol.
- Subjects with a change in thyroid medication within the last 6 weeks prior to screening.
- Subjects who have had fluoride treatment for 2 weeks or more (> 2 mg/day fluorideion) at any time (NaF tablets for caries prevention is allowed).
- Subjects who have undergone systemic glucocorticoid treatment (> 5 mg prednisone or equivalent/day) for more than one month within the past 6 months (prior to BMD screening assessments).
- Subjects who are receiving or require medication for the treatment of osteoporosis except Calcium / Vit D.
- The use of coumarin products.
- Type I diabetes mellitus.
- Presence or history of thromboembolic disorders.
- Serious decompensated renal or liver disease.
- Abnormal laboratory values
- Any condition or disease that could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the investigational product.
About this study
Official title: A Multinational, Randomized, Double-Blind, Parallel Group Comparative Trial on the Effects of 2 Years Treatment With Tibolone (1.25 mg Org OD 14) and Raloxifene (60 mg) on Bone Mineral Density in Osteopenic Postmenopausal Women
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.
- Conditions
- Osteopenia
- Being tested
- tibolone, raloxifen
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tiboloneDrug
2 years treatment with tibolone (1.25 mg Org OD-14)
raloxifenDrug
2 years treatment with raloxifene (60 mg)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | tibolone Receives: Drug: tibolone |
| 2 | Active comparator | raloxifene Receives: Drug: raloxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure BMD to evaluate the effects of treatment on bone mineral density of the lumbar vertebrae L1-L4
Measured: At screening, after 52 weeks and 104 weeks
Secondary outcomes (6)
To measure the effects on hot flushes by using diary booklets
Measured: Throughout trial and up to week 52
To measure the economic impact during the whole trial period by using Medical resource utilization forms
Measured: Baseline and week 52 and 104
Bone mineral density of the total hip
Measured: At screening, week 52 and week 104
A vaginal smear to determine vaginal atrophy
Measured: At screening, week 52 and week 104
Biochemical markers of bone metabolism
Measured: At baseline, week 12, week 24, week 52 and week 104
McCoy Female Sexuality Questionnaire, Short -Form to assess sexual functioning, Women's Health Questionnaire to assess quality of life, Health Utility Index Mark 2 and 3 (HUI2/HUI3) to confirm the health status
Measured: At baseline, week 12, week 24, week 52 and week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study start31 Jul 2000
- Primary completion15 Feb 2005
- Study completion15 Feb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431431
- Sponsor's protocol ID
- P06090
- Other IDs
- E-1693
- Acronym
- STEP
- Status last verified
- Feb 2022
- First submitted
- 2 Feb 2007
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18256777
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Randomized, Double-Blind, Parallel Group Comparative Trial on the Effects of 2 Years Treatment With Tibolone (1.25 mg Org OD 14) and Raloxifene (60 mg) on Bone Mineral Density in Osteopenic Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00431431
- Acronym / sponsor ID
- STEP / P06090
- Conditions
- Osteopenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2000 (actual)
- Primary completion
- 15 Feb 2005 (actual)
- Study completion
- 15 Feb 2005 (actual)
- First posted
- 5 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tibolonetibolone |
| 2 | Active comparator | Drug: raloxifenraloxifene |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Subjects should have a Body Mass Index (BMI) >19 and < 30 kg/m2.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tibolone2 years treatment with tibolone (1.25 mg Org OD-14) | Drug | 1 |
| raloxifen2 years treatment with raloxifene (60 mg) | Drug | 2 |
Primary outcome
Measure BMD to evaluate the effects of treatment on bone mineral density of the lumbar vertebrae L1-L4
Time frame: At screening, after 52 weeks and 104 weeks
6 secondary outcomes
To measure the effects on hot flushes by using diary booklets
Time frame: Throughout trial and up to week 52
To measure the economic impact during the whole trial period by using Medical resource utilization forms
Time frame: Baseline and week 52 and 104
Bone mineral density of the total hip
Time frame: At screening, week 52 and week 104
A vaginal smear to determine vaginal atrophy
Time frame: At screening, week 52 and week 104
Biochemical markers of bone metabolism
Time frame: At baseline, week 12, week 24, week 52 and week 104
McCoy Female Sexuality Questionnaire, Short -Form to assess sexual functioning, Women's Health Questionnaire to assess quality of life, Health Utility Index Mark 2 and 3 (HUI2/HUI3) to confirm the health status
Time frame: At baseline, week 12, week 24, week 52 and week 104
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Results publication: PubMed 18256777Delmas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tibolone and raloxifen in people with Osteopenia, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure BMD to evaluate the effects of treatment on bone mineral density of the lumbar vertebrae L1-L4 (time frame: At screening, after 52 weeks and 104 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00431431, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.