Postmenopausal OsteoporosisPhase 3NCT00165698
Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women
A Phase 3 study testing menatetranone and alfacalcidol in people with Postmenopausal Osteoporosis, run by Eisai Co., Ltd. at 5 sites in China.
Trial summary
To determine the effect and safety of menatetrenone on treatment of postmenopausal osteoporosis comparing with alfacalcidol. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- menatetranone and alfacalcidol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 5 sitesChina
- Study dates
- May 2005to Jul 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 75 years
- Women only
- Adult, Older adult
Who may be able to join
- Postmenopausal women with menopause duration more than 5 years and with age between 45-75 years old (menopausal age ≥40), or if hysterectomy operated before natural menopause, the age of women between 60-75 years old.
- Subject with BMD (L2-4 or neck of femur) being more than 2 Standard Deviation (SD) below the young female adult mean (According to the standard of each center)
- BMI between 18 kg/m2-30 kg/m2.
- The anatomic structure of lumbar spine must be available for Dual-energy X-ray Absorptiometry (DEXA) examination, patient with serious scoliosis, bone trauma or sequela after orthopedics surgery, which makes BMD measurement difficult, should be excluded
- Subject who have given informed consent prior to participation in the trial and who undertake to comply with the protocol.
Who cannot join
- Subject with conditions that are considered to effect osteoporosis, such as clear definite diabetes mellitus, rheumatoid arthritis, rheumatoid arthritis, hyperparathyroidism or other bone metabolic diseases.
- Subjects who have received treatment with active-type vitamin D3 preparation, other vitamin D preparations (>1000IU per day）, calcitonin, corticosteroid hormone, androgen, estrogen, other hormone, vitamin K preparation, in the 3 months prior to inanition of this study; Subjects who have received treatment with bisphosphonate preparation or Sodium Fluoride in the 1 year prior to inanition of this study; Subjects who have received treatment with Selective Estrogen Receptor Modulator (SERM) in the 6 months prior to inanition of this study
- Concurrent serious renal disease, hepatic disease, uncontrolled hypertension （≥150/100mmHg）, symptomatic ischemic heart disease, cerebral infarction or arteriosclerosis obliterans.
- Cancer history within 5 years.
- Subjects who take antacid containing aluminum in the preparation, warfarin or thrombolytic agents.
- Subject with any known abnormality in laboratory tests, which is deemed to be clinically significant by the investigator, which include:
Show all 12Show fewer
- Serum alkaline phosphatace (ALP) > upper normal limit 10% (calculated according to the range of normal values of each center);
- Glutamic Oxalacetic Transaminase (AST)/ Glutamic Pyruvic Transaminase (ALT) > upper normal limit 50％(calculated according to the range of normal values of each center);
- Serum creatinine >1.5mg/dL (133μmol/L);
- Blood-fasting sugar ≥ 7mmol/L (126mg/L)
- Inability of subject to return for scheduled visits or to comply with any other aspect of the protocol.
- Subject who, in the opinion of the investigator, are poor medical candidates or pose any other risk for therapy with an investigational drug.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Beijing Hospital
Beijing
Chinese PLA General Hospital
Beijing
Peking Union Medical College Hospital
Beijing
Hua Dong Hospital
Shanghai
The Sixth People's Hospital affiliated to Shanghai Jiaopong University
Shanghai
About this study
To determine the effect and safety of menatetrenone on treatment of postmenopausal osteoporosis comparing with alfacalcidol.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- menatetranone, alfacalcidol
- Keywords
- Postmenopausal, osteoporosis
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
menatetranoneDrug
15 mg three times a day orally for 12 months
alfacalcidolDrug
0.25 μg twice a day orally for 12 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: menatetranone |
| 2 | Active comparator | Not described Receives: Drug: alfacalcidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months
Measured: Baseline and 12 months
Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months
Measured: Baseline and 12 months
Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months
Measured: Baseline and 12 months
Secondary outcomes (7)
Bone Mineral Content BMC (Percentage) Change in Lumber Spine After 12 Months
Measured: Baseline and 12 months
Bone Mineral Content BMC (Percentage) Change in Collum Femoris After 12 Months
Measured: Baseline and 12 months
Bone Biomarker Osteocalcin (OC) Percentage Change After 12 Months
Measured: Baseline and 12 months
Bone Biomarker Undercarboxylated Osteocalcin (UCOC) Percentage Change After 12 Months
Measured: Baseline and 12 months
Bone Biomarker Undercarboxylated Osteocalcin/Osteocalcin (UCOC/OC) Percentage Change After 12 Months
Measured: Baseline and 12 months
New Fracture and Fall
Measured: 12 months
Height (Meter)
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionJan 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postmenopausal OsteoporosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hong Di, Study director, Eisai China Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165698
- Sponsor's protocol ID
- AS-012 (GLA-CHN-05-01)
- Status last verified
- Jul 2014
- First submitted
- 12 Sep 2005
- Last updated
- 22 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women
- ClinicalTrials.gov ID
- NCT00165698
- Acronym / sponsor ID
- AS-012 (GLA-CHN-05-01)
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- Postmenopausal, osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Posted 11 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effect and safety of menatetrenone on treatment of postmenopausal osteoporosis comparing with alfacalcidol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: menatetranone |
| 2 | Active comparator | Drug: alfacalcidol |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal women with menopause duration more than 5 years and with age between 45-75 years old (menopausal age ≥40), or if hysterectomy operated before natural menopause, the age of women between 60-75 years old.
- Subject with BMD (L2-4 or neck of femur) being more than 2 Standard Deviation (SD) below the young female adult mean (According to the standard of each center)
- BMI between 18 kg/m2-30 kg/m2.
- The anatomic structure of lumbar spine must be available for Dual-energy X-ray Absorptiometry (DEXA) examination, patient with serious scoliosis, bone trauma or sequela after orthopedics surgery, which makes BMD measurement difficult, should be excluded
- Subject who have given informed consent prior to participation in the trial and who undertake to comply with the protocol.
Key exclusion criteria (12 listed)
- Subject with conditions that are considered to effect osteoporosis, such as clear definite diabetes mellitus, rheumatoid arthritis, rheumatoid arthritis, hyperparathyroidism or other bone metabolic diseases.
- Subjects who have received treatment with active-type vitamin D3 preparation, other vitamin D preparations (>1000IU per day）, calcitonin, corticosteroid hormone, androgen, estrogen, other hormone, vitamin K preparation, in the 3 months prior to inanition of this study; Subjects who have received treatment with bisphosphonate preparation or Sodium Fluoride in the 1 year prior to inanition of this study; Subjects who have received treatment with Selective Estrogen Receptor Modulator (SERM) in the 6 months prior to inanition of this study
- Concurrent serious renal disease, hepatic disease, uncontrolled hypertension （≥150/100mmHg）, symptomatic ischemic heart disease, cerebral infarction or arteriosclerosis obliterans.
- Cancer history within 5 years.
- Subjects who take antacid containing aluminum in the preparation, warfarin or thrombolytic agents.
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 |
|---|---|---|
| menatetranone15 mg three times a day orally for 12 months | Drug | 1 |
| alfacalcidol0.25 μg twice a day orally for 12 months | Drug | 2 |
Primary outcome
Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months
Time frame: Baseline and 12 months
Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months
Time frame: Baseline and 12 months
Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months
Time frame: Baseline and 12 months
7 secondary outcomes
Bone Mineral Content BMC (Percentage) Change in Lumber Spine After 12 Months
Time frame: Baseline and 12 months
Bone Mineral Content BMC (Percentage) Change in Collum Femoris After 12 Months
Time frame: Baseline and 12 months
Bone Biomarker Osteocalcin (OC) Percentage Change After 12 Months
Time frame: Baseline and 12 months
Bone Biomarker Undercarboxylated Osteocalcin (UCOC) Percentage Change After 12 Months
Time frame: Baseline and 12 months
Bone Biomarker Undercarboxylated Osteocalcin/Osteocalcin (UCOC/OC) Percentage Change After 12 Months
Time frame: Baseline and 12 months
New Fracture and Fall
Time frame: 12 months
Height (Meter)
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hong Di study director
Eisai China Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing menatetranone and alfacalcidol in people with Postmenopausal Osteoporosis, run by Eisai Co., Ltd. at 5 sites in China.
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 12 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 22 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months (time frame: Baseline and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2014.