Non-Traumatic OsteonecrosisPhase 4NCT00265252
Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis
A Phase 4 study testing Alendronate in people with Non-Traumatic Osteonecrosis, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
To determine the cumulative incidence of total hip replacement, time to event after treatment with Fosamax or placebo during the study peroid Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Non-Traumatic Osteonecrosis
- What is being tested?
- Alendronate
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2005to Jun 2008
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteonecrosis of femoral head
- be able to provide singed informed consent
Who cannot join
- prior bisphosphonate use
- pregnant or lactating woman
- bilateral hip replacement
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
About this study
To determine the cumulative incidence of total hip replacement, time to event after treatment with Fosamax or placebo during the study peroid
Read the detailed description
To determine the cumulative incidence of total hip replacement and collpase of femoral head, time to event after treatment with Fosamax or placebo during the study peroid
- Conditions
- Non-Traumatic Osteonecrosis
- Being tested
- Alendronate
- Keywords
- osteonecrosis, total hip replacement
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlendronateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
the cumulative of total hip replacement
Secondary outcomes (2)
necrotic area
Harris hip score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2005 (estimated)
- Study startJun 2005
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Traumatic OsteonecrosisStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, National Cheng-Kung University Hospital, National Taiwan University Hospital
- Investigators
- Gwo-Jaw Wang, MD, Study chair, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265252
- Sponsor's protocol ID
- fosamax 01
- Status last verified
- Apr 2007
- First submitted
- 12 Dec 2005
- Last updated
- 27 Feb 2008
- Results posted
- No
Publications
Lai KA, Shen WJ, Yang CY, Shao CJ, Hsu JT, Lin RM. The use of alendronate to prevent early collapse of the femoral head in patients with nontraumatic osteonecrosis. A randomized clinical study. J Bone Joint Surg Am. 2005 Oct;87(10):2155-9. doi: 10.2106/JBJS.D.02959.
PubMed 16203877Chen CH, Chang JK, Lai KA, Hou SM, Chang CH, Wang GJ. Alendronate in the prevention of collapse of the femoral head in nontraumatic osteonecrosis: a two-year multicenter, prospective, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2012 May;64(5):1572-8. doi: 10.1002/art.33498.
PubMed 22127729
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis
- ClinicalTrials.gov ID
- NCT00265252
- Acronym / sponsor ID
- fosamax 01
- Conditions
- Non-Traumatic Osteonecrosis
- Keywords
- osteonecrosis, total hip replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, National Cheng-Kung University Hospital, National Taiwan University Hospital
- Study start
- Jun 2005
- Study completion
- Jun 2008 (estimated)
- First posted
- 14 Dec 2005 (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.
To determine the cumulative incidence of total hip replacement, time to event after treatment with Fosamax or placebo during the study peroid
Detailed description
To determine the cumulative incidence of total hip replacement and collpase of femoral head, time to event after treatment with Fosamax or placebo during the study peroid
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- osteonecrosis of femoral head
- be able to provide singed informed consent
Key exclusion criteria (3 listed)
- prior bisphosphonate use
- pregnant or lactating woman
- bilateral hip replacement
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 | Drug | – |
Primary outcome
the cumulative of total hip replacement
2 secondary outcomes
necrotic area
Harris hip score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2008.
- Background: PubMed 16203877Lai KA, Shen WJ, Yang CY, Shao CJ, Hsu JT, Lin RM. The use of alendronate to prevent early collapse of the femoral head in patients with nontraumatic osteonecrosis. A randomized clinical study. J Bone Joint Surg Am. 2005 Oct;87(10):2155-9. doi: 10.2106/JBJS.D.02959.
- Derived from this study: PubMed 22127729Chen CH, Chang JK, Lai KA, Hou SM, Chang CH, Wang GJ. Alendronate in the prevention of collapse of the femoral head in nontraumatic osteonecrosis: a two-year multicenter, prospective, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2012 May;64(5):1572-8. doi: 10.1002/art.33498.
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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.
Gwo-Jaw Wang, MD study chair
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alendronate in people with Non-Traumatic Osteonecrosis, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 3 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 27 Feb 2008. 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 Taiwan. 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 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?
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?
the cumulative of total hip replacement. 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 NCT00265252, which also lists 2 linked publications.
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 27 Feb 2008.