Bone DensityETODNCT01020253
The Effectiveness of Two Osteoporosis Drugs on Prosthetic Bone Mineral Density (BMD) Loss After Total Hip Arthroplasty(THA)
A study testing alendronate, alfacalcidol in people with Bone Density and Arthroplasty, Replacement, Hip, run by Yokohama City University Medical Center at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate whether alendronate and alfacalcidol are effective on prosthetic or lumbar spine BMD after total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 44 to 82 years
- Conditions the study is for
- Bone Density, Arthroplasty, Replacement, Hip
- What is being tested?
- alendronate, alfacalcidol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2006to Apr 2008
- Phase
- Interventional
- 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 44 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoarthritis of the hip
- patients after total hip arthroplasty
Who cannot join
- diseases related to bone metabolism
- patients taking drugs which affect bone metabolism
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of orthopaedic surgery, Yokohama City University
Yokohama, Kanagawa
About this study
Official title: A Comparison of Alendronate vs. Alfacalcidol Medication for the Preservation of Bone Mineral Density Around the Femoral Implant and in the Lumbar Spine After a Total Hip Arthroplasty
The purpose of this study is to evaluate whether alendronate and alfacalcidol are effective on prosthetic or lumbar spine BMD after total hip arthroplasty.
- Conditions
- Bone Density, Arthroplasty, Replacement, Hip
- Being tested
- alendronate, alfacalcidol
- Keywords
- bisphosphonate, vitamin D3, Total Hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alendronate, alfacalcidolDrug
Alendronate: 5mg per day, Tablet, Duration is 48 weeks. Alfacalcidol: 1μg per day, Tablet, Duration is 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Alendronate medication | Active comparator | Not described Receives: Drug: alendronate, alfacalcidol |
| Alfacalcidol medication | Active comparator | Not described Receives: Drug: alendronate, alfacalcidol |
| Non-medication | No intervention | Not described Receives: Drug: alendronate, alfacalcidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
DEXA QDR 2000, Hologic Co.
Measured: 1, 12, 24 and 48 weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startJan 2006
- Primary completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DensityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yokohama City University Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020253
- Sponsor's protocol ID
- YCU07-122
- Acronym
- ETOD
- Status last verified
- Dec 2009
- First submitted
- 24 Nov 2009
- Last updated
- 3 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Alendronate vs. Alfacalcidol Medication for the Preservation of Bone Mineral Density Around the Femoral Implant and in the Lumbar Spine After a Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01020253
- Acronym / sponsor ID
- ETOD / YCU07-122
- Conditions
- Bone Density, Arthroplasty, Replacement, Hip
- Keywords
- bisphosphonate, vitamin D3, Total Hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yokohama City University Medical CenterUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Apr 2008 (actual)
- First posted
- 25 Nov 2009 (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.
The purpose of this study is to evaluate whether alendronate and alfacalcidol are effective on prosthetic or lumbar spine BMD after total hip arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alendronate medication | Active comparator | Drug: alendronate, alfacalcidol |
| Alfacalcidol medication | Active comparator | Drug: alendronate, alfacalcidol |
| Non-medication | No intervention | Drug: alendronate, alfacalcidol |
Who may qualify
- Ages
- 44 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- osteoarthritis of the hip
- patients after total hip arthroplasty
Key exclusion criteria (2 listed)
- diseases related to bone metabolism
- patients taking drugs which affect bone metabolism
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 |
|---|---|---|
| alendronate, alfacalcidolAlendronate: 5mg per day, Tablet, Duration is 48 weeks. Alfacalcidol: 1μg per day, Tablet, Duration is 48 weeks. | Drug | Alendronate medication, Alfacalcidol medication, Non-medication |
Primary outcome
DEXA QDR 2000, Hologic Co.
Time frame: 1, 12, 24 and 48 weeks after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alendronate, alfacalcidol in people with Bone Density and Arthroplasty, Replacement, Hip, run by Yokohama City University Medical Center at 1 site in Japan.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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.
Are results available for this study?
Results are not available in the source record.
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?
DEXA QDR 2000, Hologic Co. (time frame: 1, 12, 24 and 48 weeks after operation). 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 3 Dec 2009.