OsteoporosisPhase 4NCT00460057
The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women With Bone Loss
A Phase 4 study testing Alendronate in people with Osteoporosis, run by Eulji University Hospital.
Trial summary
High bone turnover with the bone resorption exceeding bone formation is a major mechanism of postmenopausal osteoporosis. Therefore, inhibition of bone resorption is a rational approach for the prevention. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Alendronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Feb 2007
- 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 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- postmenopausal women (the ages between 50-65 year) with lumbar spine BMD at least 2.0 SD below the peak young adult mean
Who cannot join
- severe osteoporosis
- current medication of osteoposis
- metabolic bone disease
- cancer, stroke etc.
About this study
Official title: The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women
High bone turnover with the bone resorption exceeding bone formation is a major mechanism of postmenopausal osteoporosis. Therefore, inhibition of bone resorption is a rational approach for the prevention. The Objective of the current study was to determine the short-term efficacy of once-weekly low dose alendronate in the prevention of bone loss in early postmenopausal Korean women with moderate bone loss via bone turnover markers.
This study was a 12-week, randomized, double-blind clinical trial compared the effects of placebo with alendronate 20 mg once weekly. All subjects received supplemental calcium 600 mg and vitamin D 400 IU daily. Fifty two postmenopausal women (the ages between 50-65 year) with lumbar spine BMD at least 2.0 SD below the peak young adult mean were recruited at Eulji University Hospital, Daejeon, Korea. BMD was measured by DXA at baseline and serum alkaline phosphatase, osteocalcin and C-terminal telopeptide of type I collagen was measured at baseline and 12 weeks after treatment.
- Conditions
- Osteoporosis
- Being tested
- Alendronate
- Keywords
- osteoporosis, alendronate, bone marker
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlendronateDrug
Also called Bisphosphonate
Take two tablets (alendronate 10 mg) once weekly with a full glass of plain water in the morning after an overnight fast and to refrain from lying down or taking any other beverage or food for at least 1 h thereafter
| Study group | Role | What they receive |
|---|---|---|
| Alendronate, Placebo | Placebo comparator | All subjects were given 600 mg of calcium and 400 IU of vitamin D supplements. The subjects were randomized to receive weekly alendronate 20 mg (n = 31) or placebo (n = 32). Receives: Drug: Alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of bone turnover markers
to determine the short-term efficacy of once-weekly low-dose alendronate, via bone turnover markers and OPG, in the prevention of bone loss in early postmenopausal Korean women with moderate bone loss.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startMar 2006
- Primary completionDec 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eulji University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Jeong Choi, Eulji University Hospital
- Investigators
- Hee-Jeong Choi, MD, PhD, Principal investigator, Department of Family medicine, Eulji University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460057
- Sponsor's protocol ID
- EJRG-06-001-11E32
- Status last verified
- Aug 2014
- First submitted
- 12 Apr 2007
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00460057
- Acronym / sponsor ID
- EJRG-06-001-11E32
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, alendronate, bone marker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Eulji University HospitalUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 13 Apr 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.
High bone turnover with the bone resorption exceeding bone formation is a major mechanism of postmenopausal osteoporosis. Therefore, inhibition of bone resorption is a rational approach for the prevention. The Objective of the current study was to determine the short-term efficacy of once-weekly low dose alendronate in the prevention of bone loss in early postmenopausal Korean women with moderate bone loss via bone turnover markers.
This study was a 12-week, randomized, double-blind clinical trial compared the effects of placebo with alendronate 20 mg once weekly. All subjects received supplemental calcium 600 mg and vitamin D 400 IU daily. Fifty two postmenopausal women (the ages between 50-65 year) with lumbar spine BMD at least 2.0 SD below the peak young adult mean were recruited at Eulji University Hospital, Daejeon, Korea. BMD was measured by DXA at baseline and serum alkaline phosphatase, osteocalcin and C-terminal telopeptide of type I collagen was measured at baseline and 12 weeks after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alendronate, Placebo | Placebo comparator | Drug: AlendronateAll subjects were given 600 mg of calcium and 400 IU of vitamin D supplements. The subjects were randomized to receive weekly alendronate 20 mg (n = 31) or placebo (n = 32). |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- postmenopausal women (the ages between 50-65 year) with lumbar spine BMD at least 2.0 SD below the peak young adult mean
Key exclusion criteria (4 listed)
- severe osteoporosis
- current medication of osteoposis
- metabolic bone disease
- cancer, stroke etc.
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 |
|---|---|---|
| AlendronateAlso: BisphosphonateTake two tablets (alendronate 10 mg) once weekly with a full glass of plain water in the morning after an overnight fast and to refrain from lying down or taking any other beverage or food for at least 1 h thereafter | Drug | Alendronate, Placebo |
Primary outcome
Changes of bone turnover markers
Time frame: 12 weeks
to determine the short-term efficacy of once-weekly low-dose alendronate, via bone turnover markers and OPG, in the prevention of bone loss in early postmenopausal Korean women with moderate bone loss.
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 5 Aug 2014.
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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.
Hee-Jeong Choi, MD, PhD principal investigator
Department of Family medicine, Eulji University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alendronate in people with Osteoporosis, run by Eulji University Hospital.
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 1 inclusion and 4 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 5 Aug 2014. 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. Some participants in this study may receive a placebo. 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?
Changes of bone turnover markers (time frame: 12 weeks). 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 5 Aug 2014.